AT	DEPARTMENT OF HEALTH AND HUMAN SERVICES PRIVATE

	FOOD AND DRUG ADMINISTRATION

	CENTER FOR DRUG EVALUATION AND RESEARCH

	PUBLIC MEETING:

	PROPOSED CHANGES

	TO THE NATIONAL DRUG CODE (NDC) SYSTEM

	Monday, December 11, 2006

	9 o'clock a.m.

	Advisors and Consultants Conference Room 1066

	5630 Fishers Land

	Rockville, Maryland

	PARTICIPANTS

Panel Members:

Michael Bernstein

  	 Director, Division of Regulatory Policy II

   	 Office of Regulatory Policy, CDER, FDA

	John Gardner, M.D., DrPH

	 Director, Division of Compliance, Risk

	 Management and Surveillance, CDER/FDA

	Judith A. Geisler, R.Ph.

	 Acting Director, Division of Finance and

	 Operations, Centers for Medicare and

	 Medicaid Services

	Charise S. Kasser

	 Consumer Safety Officer, Division of

	 Surveillance HFV-212, Center for

	 Veterinary Medicine

	Randy Levin, M.D.

	 Director for Health and Regulatory Data

 Standards, FDA, Associate Director of

 Medical Informatics, CDER

	Anita Richardson

	 Associate Director for Policy, Office of

	 Compliance and Biologics Quality,

	 CBER/FDA

	C O N T E N T S

Opening Remarks:

	Michael Bernstein	5

Overview:

	John Gardner, M.D., DrPH	7

Introduction of the Panel:

	Michael Bernstein	29

Public Speakers:

	Kay Morgan

	 NCPDP	31

	John M. Coster, Ph.D., R.Ph.

	 NACDS	36

	John Klimek, R.Ph.

	 Super Valu	43

	John Roberts

	 GS1 US BarCodes and eCOM	51

	Diane Servello

	 Watson Laboratories, Inc.	65

	Dr. Thomas F. Willer

	 Hospira, Inc.	74

	Scott M. Melville

	 Healthcare Distribution Management

	 Association	84

Open Discussion	104

Public Speakers:

	Heidi Horn

	 Perrigo Company 	111

	Madeline Palla

	 Animal Health Institute	162

	Marc J. Meteyer

	 Compressed Gas Association	169

	C O N T E N T S (Continued)

	John K. Willenbrock

	 Gas Regs, Inc.	176

	Paul J. Larsen

	 Consumer Healthcare Products Association	182

	A. Wes Siegner, Jr.

	 Hyman, Phelps & McNamara, P.C.	199

	Carolyn D. Jones

	 Advamed	204

	Pat Distler

	 ICCBBA	211

	M. Allene Carr-Greer, MT (ASCP)SBB

	 AABB	229

Open Discussion 	245

Closing Remarks 	253

	P R O C E E D I N G S

	Opening Remarks

	MR. BERNSTEIN:  I'm Michael Bernstein.  I am the Director of the
Division of Regulatory Policy II in the Office of Regulatory Policy in
CDER.  I will be moderating today's meeting on the National Drug Code
System.

	As you all know, FDA published its electronic drug registration and
listing proposed rule at the end of August and we recently extended the
comment period to January 26th.  We also announced that we would hold
this public meeting on the NDC Code topic.

	The purpose of this meeting is to solicit public input on the proposed
changes to the National Drug Code system that is contained in that
proposed rule.  We have a large number of speakers who have requested
time today and time is limited, as I said, so please try to limit
yourself to the allotted time on the agendas that I think have
circulated.  If, after you are introduced, you could state your name and
affiliation and move right to your presentation, that would be
appreciated.

	We also have a panel of FDA staffers and a representative from CMS.
They are largely going to listen today although they may ask some
questions of presenters.  But we are going to try to keep those
questions limited to clarification questions.

	The role of FDA here today is to listen to the speakers and consider
your concerns and your viewpoints on issues relating to the National
Drug Code system.  So please don't expect to hear guidance, substantive
guidance, from the panelists.

	We have also tried to schedule some time for audience comments and
participation at the end of both sessions.  Time permitting, we will do
that.  There will be two microphones.

	Before we get to the presentations, Dr. John Gardner, of the Office of
Compliance, is going to open the meeting with a very brief overview of
the electronic drug registration and listing proposal on the NDC issues
and review the specific discussion topics very briefly that were raised
in the meeting notice.

	After that, we will introduce the panel and then we will get right to
the public presentations.  So, without further ado, Dr. Gardner?

	Overview

	DR. GARDNER:  Good morning.  I wanted to briefly give you an overview
of what we are trying to propose and where we are going in terms of
electronic drug registration and listing.  I want to emphasize that
where we are going is very flexible.  We are not moving forward with
anything definitive until we are through reviewing all the comments that
have come in on the proposed rule and that resolve a lot of the issues
that are raised there.

	So the rule, itself, really has five major components that are changes.
 The first is that there is electronic submission of the registration
listing information.  We are developing two systems to do that, one for
electronic registration, which we call the Drug Facility Registration
Module, which is a component of the FDA Uniform Registration and Listing
System.

	The second is a program we call eLIST which has been formulated and is
about to be developed.

	The second piece is electronic submission of the content of labeling.
That is already a requirement for application prescription drugs.  This
rule would extend that requirement to all drugs that the content of
labeling, what we call the structured product labeling (SPL), would be
required to be submitted electronically.

	The third change is that FDA would issue the complete NDC number, not
just the labeler code as we currently do.  I will talk to you a little
bit more about that later.  The NDC directory will then become the
public posting of all FDA-issued NDC numbers and that will be
coordinated with the DailyMed website.

	The fourth change is that the NDC number will be required to be printed
on product labels.  That requirement is proposed to be the appropriate
NDC number which is the last firm which has handled the product--that
is, changed the product.

	Let me now clarify the difference between a drug and drug product.  A
drug is, for example ampicillin.  A drug product example ampicillin, 250
milligram tablets made by a specific company and marketed by a specific
company in bottles of 30.  Each drug product has a unique NDC number and
there are often many, and sometimes, hundreds of NDC numbers for each
drug.

	This product would have to have the NDC number printed on it and the
reason, our thinking on why it has to be the most recent, is so that we
can trace that back from the private-label distributor to the relabeler,
to the repacker, to the manufacturer so we can deal with specific
product issues.

	Then, finally, the final change proposed is that firms must recertify
their listing information every six months.  Currently, they have to
update their information in June and December if it has changed, then
this would require that they come in and certify that it has not changed
or change it if it has changed.

	So those are the five major components of the proposed rule.  I want to
now talk to you about our drug registration listing system.  This
program comes under my division in the Office of Compliance.

	Drug-establishment registration and drug-product listing was enacted to
protect the public from adulterated and misbranded drugs.  Drug
establishments must register annually to provide contact and location
information.  Firms must list each of their drug products that are being
marketed in the United States, giving names and ingredients, et cetera.

	We use these data in the system for many purposes. I think it is
central to almost everything we do, being able to identify the drug
products.  It is the repository of NDC numbers.  Registration currently
provides, and in the future would provide, the labeler component of the
NDC.  Registration gives us location and contact information so that we
can identify who is making drugs and it identifies sites for inspection.

	Listing provides the manufacturing information, ingredients
information, for marketed drugs.  It helps us to identify violative drug
products.  It assists with control of drug imports.  The electronic
system will support the SPL DailyMed initiative.  Its key role is to
provide linkage of a drug product, a specific drug product, with the
labeling, with the approval status, with the marketer and with the
manufacturer so that we can know each of these components related to
each specific drug product.

	It helps counterterrorism, supports our FDA safety databases by, again,
linking the specific products to the issues, helps us in drug shortages.
 We have used it frequently to identify products containing an
ingredient is being recalled; we use this system to identify the
manufacturers and the products that are out there that have that
ingredient.

	In Hurricane Katrina, we were one of the first people who were called,
saying, "What firms might be impacted by the hurricane? Is that a
problem we need to worry about in terms of drug supply and shortages?"
and so on.

	We also have the repository of drug-product labeling which currently is
in paper system but, under the proposed rule, we would make electronic.

	The NDC is also used in drug billing and reimbursement.  The Centers
for Medicaid and Medicare Services use our information to determine drug
eligibility for their rebate and reimbursement programs.  The NDC
directory is widely used for lots of reasons.  Nearly all pharmacy
billing systems and reimbursement systems use the NDC.  So we think it
is extremely important to keep that information complete and accurate.

	The history started way back in the '70s, a paper system.  Our current
Oracle system was developed in 1991 and we are now developing the new
electronic system with the two components that I mentioned.

	We have about 25,000 active facilities registered.  We are estimating
approximately 200,000 specific drug products on the market.  We do not
have all of those in our electronic system.  Due to resource
limitations, part of those are still in paper systems.  One of the
reasons for this rule is to change that and get everything electronic.

	We spent a lot of money processing about 10,000 registration forms and
30,000 listing forms each year.  Just the data-entry process, itself, is
nearly a million dollars a year that we are struggling to maintain.
Because of limitations, we haven't been able to maintain everything in
the electronic system.

	This slide provides a list for you of the information we have for each
firm and each manufacturer and of the products and the functions related
to those product.  You can read these on the slides when we post them.

	In the future, we are already moving toward an electronic drug
registration and listing system.  We would provide the electronic
submission on an on-line basis for registration and, as I will mention,
through submission of electronic labeling for drug-product listing, this
will greatly improve the accuracy and completeness of our system,
minimize data-input requirements (I think both for us and for industry),
and allow more focus on the safety and regulatory issues.

	Our plans are to implement these new features of registration listing
and, in the process, implement partially automated validation of the
listings so that we can avoid a lot of the manual review that would be
necessary otherwise.

	First, let me talk about drug-establishment registration.  This is
already in the works.  Our system is already partially developed and
implemented internally, the drug-facility registration module (DFRM).
We will soon be providing access for industry so that industry will be
able to get an account in FURLS, log in to DFRM and then enter and/or
update their registration electronically.  All paper forms will
eventually be eliminated and annual updating will be greatly simplified.
 I will show you that in just a minute.

	This will be the central system through FURLS that will be the master
inventory of drug establishments and their official contact and importer
information.

	This is a screen shot of FURLS, with hypothetical data.  Basically, as
you enter, you go through an eight-step process that takes about ten
minutes if you have the information ready.  When you update, you will go
back and pull up the information that is already there through this
process shown on the slide.

	As you see here, you just scroll down through the page.  You get to
Section 1.  You look at it.  If you have changes, you click the edit
button that takes you to this section to do the editing.  Section 1
gives you the type of registration and the type of facility and your
registration number.  It will be controlled by a password system so that
only you will be able to access it.

	Then you get to Section 2 which gives the name, address and so on.
Then you get to Section 3 which goes through your preferred contacts and
contact, address.  Then you go to Section 4 which gives your
parent-company information. Section 5 is your official contact
information and section 6 is trade names.

	Section 7 is your U.S. agent information if you are a foreign firm.
Then Sections 8, 9 and 10, I didn't give you slides of, but they are
importers in Section 8.  Section 9 is the type of activities conducted
in the facility and Section 10 is a certification statement.

	So let me move from registration toward listing.  I’m presenting the
way we are designing Listing, and our current thinking is to run this
using structured product labeling that is, your electronic product
label. The electronic SPL requirement in XML format is already in place
for the content of labeling for application prescription drugs. It
allows electronic edit, search, review, and archiving of drug labeling.
That drug labeling is the prescriber package insert or the content of
labeling, as we define it.

	In October of last year (2005), industry started providing SPL for
application human prescription drugs and, through their annual reports,
should have submitted all of those by now.  Those are being processed
and posted, once their processing is complete, at the National Library
of Medicine’s DailyMed website. You can go to that website and see the
information there that gives you the entire content of labeling.

	Of most interest right now is, at the end, you will see a table, a data
table.  That data table is basically the listing information.  So our
proposed eLIST system will capture that data table and utilize that for
electronic drug listing.

	So this listing information and the SPL information will all integrate
eventually with electronic prescribing and public drug information
access programs.

	So our eLIST system is being designed around these SPL submissions and
will extract the coded data elements from the SPL and then, for the
small amount of information that is not in the product labeling,
industry will log in, through FURLS, and add that additional
information.

	Then the system we are developing will electronically validate as much
of the listing information as possible including the structure and
format of the NDC number.  Our current thinking is that we will have the
SPL submitted with the company's proposed NDC number on it.  It will
validate and verify that it meets the required rules--that is, the
format and the structure.

	The labeler code has to be the right labeler code.  The product code
has to be the same for the same product and different for a different
product, and so on.  Then, if it validates the format and structure, it
will be accepted and the company immediately notified that that NDC
number is accepted.

	It will not be legal NDC number until the entire drug-approval and
listing process is complete.  Once that is done, then it will be
issued--that same number will be issued and posted in the NDC Directory
and the DailyMed website along with electronic labeling and other FDA
information systems.

	eLIST will also electronically validate that that drug has been
approved or that the OTC Monograph requirements have been met and then
also we will check on the labeling approval.  Once that is completed
then, as I mentioned, all this will be posted.

	So this system is designed to greatly facilitate drug listing both for
industry and for us and it will improve the accuracy and completeness of
the information.  It will eliminate having to enter information twice.
You do it once on your drug label and never have to do it again.

	Every time you change your drug label, you resubmit that to FDA and it
will automatically validate through the same process again.  Parts of
the process may require manual validation.  Those may take a little bit
longer, but the automated validation components will happen immediately.

	The validation will have to be implemented so we maintain flexibility.
Our current thinking is that the validation would verify that the NDA is
approved, or ANDA, or that the product meets the over-the-counter drug
monograph requirements if it is an over-the-counter drug without an NDA.

	This year, we recalled two brands of vapor patches, over-the-counter
vapor patches. These companies really should have been notified at the
time they listed the products that these require an NDA, as do all
extended-release products, for example.  So if the system automatically
determined that you have an extended-released product without an NDA,
then you would get a notification back that this requires an NDA to be
legally marketed.

	It would also provide the accurate linkage with the NDC Directory, with
FDA's drug-information systems, and tie together everything we have
about drugs and link them specifically to those individual unique drug
products.

	This is all a part of a larger program whose goals are to provide
accessible electronic medication information--DailyMed is a big piece of
that--and eventually to provide for electronic drug prescribing and,
secondly, to provide accurate identification of drug products and
biologic products on the market.

	This goes back to the electronic labeling rule which applies to
application prescription drugs.  It goes back to the Physician Labeling
Rule which prescribes the format of that electronic label.  Then this is
the drug listing rule.  Through this process of information collection,
the manufacturers, repackers, relabelers, submit the types of
information and the data coding of that information, the electronic
listing and medication information comes forward.

	The drug labels (the SPLs) are processed through a program called
ELIPS, where they are reviewed, edited and approved.  The electronic
listing would be processed through eLIST.  Once all of this validation
and quality control is determined, then they become public and are made
publicly available in standardized form to populate standardized
electronic data systems such as DailyMed which then could be downloaded
to use as a source for other information systems.

	This illustrates this listing process for application drugs that have
their SPL submitted through the application process.  That information
will be captured through this listing system. The NDC will be pulled and
validated and that can happen as soon as the labels have been submitted
at any time, even with a preliminary label being submitted.  Then the
validation of the approval status goes through the NDA or ANDA process.
For drugs that don't go through that process we will have some
electronic validation of labeling structure, format and, perhaps,
content, to the extent we can do it electronically.  But some of that
will have to be done manually.  What I was talking about there is non
application drugs with SPL. Then you have certain categories of drugs
without SPL, like bulk ingredients, that would come in.  We would have a
system there for them to enter that information or submit in XML or a
to-be-specified format.

	Then you have the repacker, relabelers, who would come in with their
products.  They simply have to submit the NDC number of the listed
product.  If they have a properly listed product, they simply submit
that NDC number and then we pull the information from that listed
product and they would add what they need to change this to the drug
labeling, like the name and how supplied section.  Then their SPL would
be created for them.

	Again, the NDCs that they submit will all be validated.  The listing
and labeling information would be validated.  Then those would be posted
to FDA and NLM sites for access electronically to the healthcare
community.

	The other piece of this is to go in and update information and the
semi-annual certification.  Our thinking, at present, is that, since the
law says June and December, on June 1, you would get an e-mail that
says, here is your product that needs to be updated.

	You click a button on that e-mail.  It brings you right to the
certification statement where you review your information.  Then you can
review your information and update at that time.

	That is another piece I didn't mention.  Part of the electronic
submission proposed rule requires e-mail addresses and fax numbers,
which are not in the current regulation.

	So that is really an overview of our thinking and where we are trying
to go with electronic registration and listing.

	Now I want to talk just a little bit about the scope of the meeting.
We are holding this meeting to get comment on the NDC issues related to
the proposed rule.  We have listed a few of them that are major points.
The rule is open for comment until January 26th. At this meeting, we are
trying to limit our discussion to the NDC-related issues.

	One is that the NDC number is printed on the product label and that it
be the appropriate NDC number of the last firm handling the product.
Again, that is for the public-health purpose of being able to trace the
specific product back to the original manufacturer.

	The format of the printed NDC number--that is, it will be preceded by
an “NDC”.  The example I have given here is not a current legal NDC.
 But I put it up this way because this is how we carry it in our
database.  We carry it in our database as three separate fields, the
labeler code, the product code and the package code. Under current
regulations, that has to collapse to 10 digits by using a 5-4-1 or 5-3-2
or 4-4-2 configuration.  That collapsing, then, causes a lot of
confusion.  So, in the bottom bullet, we are requesting comment on the
impact of expanding to 11 digits which, I believe, is the
Medicare-Medicaid standard.

	We felt like we are constrained to 10 digits because of barcode issues.
 But, if that is not the case, I think it might be better for everyone
if we go to 11 digits.  We would like to hear comment on that issue.

	The second point is that FDA assigns and issues the full NDC number and
we feel that that is critically important to do in order to control the
use of these NDC numbers and make sure that they are formatted properly.
 Again, with the automated validation, we would then be able to inform
firms immediately of product requirements they may not have been aware
of, such as they require a new drug application or they are not
compliant with the OTC monograph, and so on.  Again, we would publish,
in the NDC Directoy, the listing of all legal or valid FDA-issued NDC
numbers.

	The third point is NDC number use and restrictions; that is, the
product code must change if the product changes, if the formulation
changes or the manufacturer changes.  That, again, is identifying unique
products.

	I know there is an issue with inactive ingredients but there are
certain inactive ingredients that some patients are allergic to, and so
on.  So we need to be able to identify those products that have
different inactive ingredients as different products and, therefore,
different NDC numbers.

	The NDC number must be the same if it is the same formulation and
manufacturer or if you discontinue a product and reintroduce that
product without change, then it has to be the same NDC number and not a
new one.  Also, you can't use the same NDC number for different
products.  I think that is a necessary part of uniquely identifying each
drug product on the market.

	Finally, that it is not used for non-drugs. I know there are concerns
here about reimbursement issues.  We have no role in reimbursement, but
we do want to assure that reimbursement systems understand which
products are drugs and which are not.  Non-drugs do not have NDC
numbers.  So devices or human foods that are not considered drugs by FDA
then would be reimbursed under their appropriate device or other
category, rather than as drugs.

	We have worked with the Centers for Medicaid and Medicare Services over
the last several years to remove thousands of products from their drug
reimbursement system because they are medical devices or human dietary
supplements.

	There is tremendous confusion because the initial assumption is always
that, if a product has an NDC number, then it is a drug.  That has not
been the case, but we think inappropriately so.  So we want to fix that
in this rule.  So we would appreciate having comment on that issue as
well.

	Fourth, another issue is the NDC chain; that is the chain of NDC
numbers from the private-label distributor's product back to the
relabeled product back to the repackaged product back to the
manufacturer.  It is currently proposed that this chain be confidential
because it might violate some proprietary business information.

	So we, at FDA, would be able to be able to trace back every product,
but the public wouldn't.  Whether we should make that publicly available
is an issue we would like to hear comment on because we feel that, for
public-health purposes, it might be appropriate to make that information
public.

	Finally, we have already talked about the configuration of the NDC.  We
are not proposing changing the basic configuration of the NDC
number--that is labeler code, product code and package code, but rather
that we make the format consistent for all drugs.  If we could go to
eleven digits it might eliminate confusion, if it doesn't cause a lot of
problems.  So we would like to hear comment on that issue.

	That is all I have.  I will turn the time back to Michael.

	MR. BERNSTEIN:  Thank you, John.

	Introduction of the Panel

	MR. BERNSTEIN:  At this point, I just want to introduce the panel.
Before I do that, I wanted to give some thanks, I don't know if any of
you have ever been involved in the planning for a meeting like this, but
there are an incredible number of details and things that need to be
taken care of to make sure that things run smoothly.

	I just wanted to extend special thanks to Lakshmi Cherukuri in the
Office of Compliance who, among many other people, worked exceptionally
hard to put all the details together so everything is functioning today,
so the microphones are working and everything else.  Thank you, Lakshmi,
and all of your co-workers.

	The panel today; you just heard from John Gardner.  He is the Director
of the Division of Compliance of Risk Management and Surveillance in the
Office of Compliance at CDER.  Also on my left is Dr. Randy Levin.  He
is the Director for Health and Regulatory Data Standards and the
Associate Director of Medical Informatics for CDER.

	To his left is Judith Geisler.  She is the Acting  Director of the
Division of Finance and Operations in the Centers for Medicare and
Medicaid Services.  On my right is Anita Richardson, the Associate
Director for Policy in the Office of Compliance and Biologics Quality in
CBER and Charise Kasser who is a consumer safety officer in the Division
of Surveillance in the Center for Veterinary Medicine, also on my right.

	With that, again, if I forgot to say it in my initial remarks, I invite
the registered speakers on the agenda to come up to the podium and speak
from here.

	The first speaker is Kay Morgan with the National Council for
Prescription Drug Programs, NCPDP.

	Public Speakers

	MS. MORGAN:  Good morning.  My name is Kay Morgan.  I am here
representing the National Council of Prescription Drug Programs or also
known as NCPDP on this NPRM regarding the NDC numbers.  Currently, I am
an NCPDP Workgroup 2 Product Identification Co-Chair and I have formerly
served as a member of the NCPDP Board of Trustees.

	My fellow Co-Chairs, Ann Johnston of Medco and John Klimek of
SuperValu, as well as Lynne Gilbertson, the Director of Standards
Development for NCPDP are in attendance with me.

	In addition to my NCPDP role, my professional responsibilities include
the population of a drug database with information including the NDC
number.  I have previously been responsible for the population of
similar data that include NDCs and to two other databases.

	NCPDP is a nonprofit ANSI-accredited standards development organization
consisting of more than 1300 members who represent computer companies,
drug manufacturers, pharmacy chains, independent pharmacies, drug
wholesalers, insurers, mail-order, prescription-drug companies,
telecommunication vendors, prescription-drug provider softwares,
physician services, service organizations, government agencies and other
parties interested in electronic standardization within the pharmacy
services sector of the healthcare industry.

	NCPDP has sent a written response to the FDA regarding this NPRM.  My
statements will speak to and highlight the NCPDP written response.  The
response was created through NCPDP's process of a task group which is
open to all interested parties.

	They create the initial recommendations for the letter.  The task group
consisted of participants from different sectors of the
pharmacy-services industry.  The letter was then reviewed during an
NCPDP November work group meeting and, again, by different sectors of
the pharmacy-services industry and then was approved by the NCPDP Board
of Trustees.

	The NCPDP comments are: according to its interpretation of NPRM, NCPDP
applauds the recommendation to disallow re-use of an NDC number once it
is discontinued.  Additionally, NCPDP highly approves the retention of
the basic core NDC enumeration system, the requirement of a new NDC when
a physical change is made and when an inactive ingredient change is
made.

	It is our understanding that the NDC will be part of the SPL
initiative; as such, the inclusion of the product image from the
manufacturer as part of the NDC listing would further enhance patient
safety.  Keeping this current system will prevent the disruption in the
electronic exchange of information that occurs today between patients,
pharmacies, processors, insurers and suppliers.

	Disallowing the re-use of an NDC and requiring a new NDC when there is
a significant change to a product will prevent the confusion that occurs
in today's market when an NDC is re-used.  Data for the product that was
represented by the NDC must be stored off and saved so as to not
conflict with the new information for the new product.

	When attributes of a product change without an NDC change, many
databases simply overlay the old information with the new information as
there is no other option and the old product may still be in the
marketplace.  This causes much confusion for the pharmacy and the
patient.

	Regarding the bar-code questions, NCPDP is very pleased to see that
this rule allows for the barcode to be continued as part of the label.
NCPDP encourages the use of the barcode to be used for the container
labeling as well as on the packaging labeling.  Barcoding of products
has been used to help correctly identify that the right product is being
dispensed.  It is vital to many quality-assurance systems and pharmacies
and to patient safety so the product being administered can be verified
as the correct product.

	Regarding the National Drug Code question.  NCPDP agrees with this
restriction cited for the use of the NDC number.  Having seen
inappropriately assigned NDCs, we support the FDA oversight of NDC
assignment.  In this rapid changing medication environment, the
assignment must occur quickly.

	NCPDP also agrees with the requirements for the electronic submission
of the NDC so that the process can occur rapidly and it will minimize
errors in transcription.  	Regarding the other postmarketing reports,
NCPDP supports this requirement that the list remain current with
actively marketed products and would encourage the FDA to use their
existing posting processes, their listservs, to provide notification of
change to the NDC listing.  Additionally, NCPDP encourages the FDA to
apply the same requirements to products listed in Part 330 human drugs
which are generally recognized as safe and effective and not misbranded
and to products listed in Part 610, general biological products
standards.

	Regarding the general conditions for general recognition of safe,
effective and not misbranded, NCPDP agrees with the listing of these
products.

	Regarding Part 601, the licensing of biologicals, NCPDP supports the
requirement for applications for biologics licenses procedures for
filing that the list remains current with actively marketed products and
would, again, encourage the FDA to use their existing posting processes
such as the listserv to provide notifications of changes to the NDC
listing.

	Thank you for the opportunity to present for NCPDP.

	MR. BERNSTEIN:  Do any of the panelists have any follow up questions
for Kay?

	If not, our next speaker is John Coster, Vice President, Policy and
Programs, for the National Association of Chain Drug Stores.

	DR. COSTER:  Thank you very much.  I am John Koster, Vice President of
Policy and Programs with the National Association of Chain Drug Stores.
I am pleased to  present comments today at this public hearing regarding
FDA's proposals to change the way that NDC numbers and used.  We are a
trade association of approximately 188 companies representing about
35,000 community-based retail pharmacies.  We appreciate the opportunity
for the public hearing and the extension of the deadline for submission
of comments given all the other rulemaking things going on in the world
today.

	Our members include small and large chain-operated pharmacies including
traditional chain drugstores, supermarkets and mass merchandise
pharmacies.  We are the largest provider of outpatient retail
prescriptions.  We provide about 70 percent of the approximately 3.1
billion prescriptions dispensed.  But changes to the NDC numbers affect
our industry and independent pharmacies as well which are about,
collectively, 55,000 pharmacies.  We will both be impacted by these
changes.

	As you will probably hear throughout the day today, the entire system,
all the way from the manufacturer to the wholesaler to the payer uses
the NDC number.  I will list these; to order, track, warehouse, account,
distribute, prescribe, dispense, bill, reconcile payment and perform
clinical functions on prescription drugs and healthcare products.  So
changes to this system, obviously, depending upon what they are, have an
impact up and down the line.  No system is perfect, but NDC scheme is
working and has worked well to date.

	NDC changes affect our industry in many ways.  Our entire business
model, as I said, os our ability to provide safe and effective
pharmaceutical care to patients.  It affects us as purchasers of
repackaged drugs, as sellers of medical equipment and supplies such as
diabetic testing supplies, as private-label distributors of
over-the-counter drugs.  Many of our members have their own
private-label brands and many of our members also warehouse their own
drugs as well.

	My colleague from SuperValu, John Klimek, will discuss some of the
operational issues of the changes.  I wanted to focus my remarks on a
particular part of the rule, specifically as it relates to the
requirement that repackagers place their own NDC number on the drugs
that they repackage.

	This is a change in policy that concerns our industry as it relates
specifically to the repackaged drugs that we purchase and use in our own
pharmacies.

	In summary, what we would like to ask is that the agency consider, in
the final regulation, that the current exemption that it has generously
provided to a specific class of repackagers--that is retail pharmacy
service repackagers--be allowed to continue under the final rule when
the rule was made final.

	This exemption has allowed these repackagers to place the originator
manufacturer's number, the NDC number of the originator manufacturer, on
the packaged product rather than their own NDC number.

	It is critical for several reasons.  Based on long-standing FDA
guidance and universal commercial practice, the retail pharmacies'
supply dispensing payment and reimbursement systems currently rely on
the use of the original manufacturer's NDC number for branded
single-source drugs.

	We are not asking the agency to grant a broad exemption for all
repackagers from the requirement that they use their own NDC because
most repackagers, in our view, are acting more like manufacturers than
they are traditional retail pharmacy service repackagers.  We are only
asking that the agency continue this narrow exemption that it has
provided to date for retail pharmacy service repackagers for a limited
number of drugs.

	The services that these repackagers provide us are invaluable.  They
help enhance efficiency in the retail pharmacy marketplace and enhance
patient safety.  If these repackagers were to go away, as we think is
possible under the rule as proposed, they would be eliminated and that
would have patient safety implications.

	The repackaging of drugs for retail pharmacy distribution, in our view,
is different from other repackaging.  All this repackaging is is simply
repackaging activities by pharmacists from hundreds of individual or
thousands of retail pharmacies to a single efficient operation that
repackages drugs into quantities that are typically dispensed to
patients by these same pharmacies.

	While this type of repackaging is done for efficiency reasons, it often
also provides important patient safety benefits.  Rather than having
repackaging occur in hundreds of thousands of different pharmacy sites,
the central retail service repackager operation reduces costs, reduces
the potential for pharmacy-based repackaging errors and reduces the
amount of time that the pharmacy needs to be involved in repackaging
medications rather than interacting with patients.

	Retail pharmacy computer systems use the original manufacturer's NDC
number to determine what product is identified for dispensing purposes.
At this time, in the  retail-pharmacy setting, the repackager NDC
numbers are not used.  In fact, many of them do not have their own.  But
 retail-pharmacy service repackagers do not have their own NDC numbers.

	For them to be used in the retail-pharmacy systems, each would have to
be assigned a number.  The number would have to be maintained by the
repackagers and recognized by different database companies, PBMs,
insurance companies, Medicaid and pharmacy software systems.
Introduction of multiple repackagers into the marketplace for which no
reimbursement metrics exist, such as AWP, WAC or AMP, would create
significant disruption in the pharmacy supply chain.

	Mandatory use of repackager NDC numbers, the retail-service repackager
NDC numbers, will also place a significant burden on retail repackagers
due to the Medicaid drug rebate requirements under Section 1927 of the
Social Security Act.  Because State Medicaid payments and calculations
are linked to NDC numbers, repackagers would be newly obliged to pay a
substantial rebate fee at a statutory minimum of 15.1 percent of the
AMP.  This fact alone could eliminate these repackagers in the
marketplace.

	It is also likely that changes in the FDA policy will create
complications in accurate billing and rebate collections for states.

	In summary, we ask, for the reasons mentioned, that the FDA in its
final rule allow for a continuation of its current policy that allows a
small number of retail-pharmacy service repackagers to continue to place
the original manufacturer's number of the repackaged product rather than
their own.

	We appreciate your consideration of this request.

	MR. BERNSTEIN:  Any questions from the panel?  Thank you.  Next up is
John Klimek, the Manager of RxView SuperValu.

	MR. KLIMEK:  Good morning.  My name is John Klimek.  I work for
SuperValu Pharmacies in the capacity of managed care, third-party
billing and pre- and post-editing of pharmacy claims using an internal
application.

	Thank you for the ability to speak in front of you this morning on the
proposed rule for NDC number.  In response to the agency assignment of
NDC, pharmacies today depend on the integrity, intelligence of the NDC.
We applaud the FDA's efforts in assuring that integrity remains intact.
Additionally, we approve the continuation of the core NDC enumeration
system.  With the advent of Medicare Part D, pharmacy billing for
prescription and non-prescription DMA products accounts for over 90
percent of pharmacies' daily business.  Therefore, it is very important
that pharmacies continue to rely on the intelligence with the NDC for
identification and billing.

	Today, we use and depend on each component of the NDC number; the
labeler, product and package code.  Depending on these individual codes
helps pharmacies and other entities develop formulary
inclusions/exclusions and drug-utilization review.  Also, when product
FDA recalls are sent from the FDA and it usually involves one labeler
and product code and all package sizes, we often use a wild card for the
package code to be certain we are in compliance with that recall
information.

	Systems in some cases use general drug identifiers such as GCN, generic
code number or GPI, generic product identifier, to program for
categories of drugs.  But, it is the structure of NDC number that gives
specificity down to the product and manufacturer level.

	The NDC touches many integral pharmacy systems.  Any change to the
expected 10-digit NDC format will have far-reaching effects both
financially to those company systems as well as potential patient safety
consequences.

	Some examples of pharmacy systems that rely on the current 10-digit NDC
structure are the pharmacy-prescription system for fill and refill,
drug-file data, drug interactions, drug-allergy and patient-counseling
information, drug-order information, prescriptions on file, pricing
formulas, third-party billing and reconciliation, transaction history
reports, reports such as DEA reports, customer-profile reports,
drug-utilization reports, customer-encounter reports, compliance
reports, and so on.

	In response to new NDC number when change of inactive ingredient, we
support the proposal in a rule that would require that a new NDC of drug
products would change when certain changes are made in the composition
of the drug product such as active ingredients.

	We have seen many situations in which a manufacturer has changed the
active ingredient--of the ingredients but has neither changed the NDC
number nor changed the name of the drug.  We agree that the NDC number
of marketed prescription-drug products should change when active
ingredients change.  However, we urge the agency to consider whether the
number of potential modifications listed in the proposed rule would
require an NDC-number  change.

	While we agree the NDC numbers should identify unique products and
packaging, we are concerned that it may be difficult to keep up with all
the NDC changes from a pharmacy system in operational perspective.
These concerns also filter into patient-safety implications.

	The NDC is in most, if not all, pharmacy systems and prescription data
is key indicator.  If an NDC number changes on a standing prescription
order, for whatever reason, it forces that pharmacy to rewrite that
prescription in assigning a new prescription number.  Doing so often
causes confusion with the patient and sometimes the physician.

	In response to dietary supplements and medical devices, many dietary
supplements and medical devices are billed each and every day for many
Medicaid and Medicare patients along with other private payers.  Each of
these products today have either a UPC or an NDC number.  Pharmacies
bill using either the true NDC number or, in some cases, of the UPC,
they use that number to format it to and NDC number.

	CPDP has developed a standard way to convert the UPC to an 11-digit NDC
format that is used for billing purposes.  This standard process is
recognized and used by all major drug compendia such as MediSpan and
First Data Bank.

	Because of the potential impact on billing for these products, any
discontinuation of a true NDC number will have significant impact on the
manufacturers of these products along within possible disruption in
supplying these products to our patients.  Consequently, any changes
should be allowed sufficient lead time to prevent interruption in
servicing our patients.

	Thank you.

	MR. BERNSTEIN:  Any questions for the speaker?

	MR. LEVIN:  Yes; I have a question.  You were mentioning about the
support to changes for the active ingredients.  You said about the other
components that might--what components would you now advocate a change?

	MR. KLIMEK;  There are some situations like when inactive ingredients
would change.  We agree with the FDA that the NDC number should change
but there are other components of that listing that could change which
may not require the NDC to change.

	MR. LEVIN:  Like an example of that?

	MR. KLIMEK:  Whatever is listed, whatever is required for the listing
of the NDC number.  I am trying to think off the top of my head.

	DR. GARDNER:  The inactive ingredients.

	MR. KLIMEK:  Right.

	MR. LEVIN:  And then for the dietary supplements, it would have an
impact if the NDCs were--

	MR. KLIMEK:  If there is no UPC--well, in most cases, where those
prices are either to HRI or UPC numbers which pharmacies today will
format that to an NDC number to bill.  So we really have no issue with
that as long as there is a product identifier that we can bill using
that code.

	DR. GARDNER:  Would you talk a little more about the 10-digit--you
mentioned the 11-digit standard for NCPDP, but then you also talked
about the need for the 10-digit version.

	MR. KLIMEK:  Again, which we had mentioned earlier, Dr. Gardner, was
about the 10-digit number being out there.  We basically take that
10-digit and format it to 11 digits.

	DR. GARDNER:  So if we started with an 11-digit number, you don't think
that would cause a lot of disruption?

	MR. KLIMEK:  Our system handles 11 digits for the NDC number.  I don't
really see where that would cause us an issue.

	DR. GARDNER:  You mentioned drug interaction or other databases that do
use 10-digit, but they convert to 11?

	MR. KLIMEK:  Right.  All systems convert to 11.

	DR. GARDNER:  They all convert to 11?

	MR. KLIMEK:  Right.

	DR. GARDNER:  Okay.  If we could convert to 11, I think we would like
to because I think that would simplify everything for everyone.  But we
need to know whether it will cause problems.

	MR. KLIMEK:  Right.  It is our thought that if it goes anything beyond
11 digits that certainly would cause more issues as far as our database
holding that large a field and, also, then, relating back the original
processing.

	DR. GARDNER:  Thank you.

	MR. BERNSTEIN:  Next up is John Roberts.

	MR. ROBERTS:  Good morning, everyone.  I am the third John in a row you
may have noticed.  I am going to wake you up now.  I am the barcode
person.  UPC is owned by GS1.  It is our standard.  Going from a
10-digit to an 11-digit NDC will cause us great problems, great
problems, indeed.  I will get into that.

	Our formal comments will be coming before January 26th.  I am a staffer
with GS1 US, a director of healthcare.  Normally our healthcare user
group will put together the comments and reply to the FDA from a global
perspective.

	I am glad that John gave the historical perspective of where the NDC
came from.  The UPC came at the same time, roughly in the early '70s.
The world has really changed since then, the National Drug Code and UPC.
 Those of you--I don't see a whole lot of grey hair, but there was a
time when we didn't have barcodes on products at all.  That started in
the early '70s.  Now, 30 years later, 40 years later, there is barcode
on everything.

	These things went on products in the early '60s and '70s.  They were
embedded into our symbols at that time, embedded into our entire system
and it carried forward.  The U.S. is the only country where we allow a
specific drug number to be coded into our system.

	Today, we are heavily integrated with global manufacturers and
distribution.  We are looking for non-standard applications, especially
in healthcare, that really threaten the flow of products information and
raise potential error.  If the FDA wants to go to the 11-digit NDC, that
is completely up to you, within your regulation.

	However, we think you should decouple it from putting in the barcode.
What do I mean by that?  There is no reason an NDC should be in a
barcode.  You could use a G-10 global-traded item number, instead, that
is used everywhere that could be passed back and forth.

	If the FDA changes the NDC from 10 to 11, it will cause serious
disruptions to our entire system.  We suggest, instead, that you delink
it and use as a primary identification a global-traded item number.
Most of us, because of the holiday season, went to the store over the
weekend.  Lots of UPCs were scanned.  How many of you know what numbers
were on them?  None of you.  I don't even look at the ones on there, but
you know what product you bought because it showed up on the computer.

	The G-10 points to the computer record that pops ups what the item is.
There is on reason for an NDC to be in there.  A G-10 works quite well.

	You can remove the NDC requirement in the barcode, use a G-10.  The
companies that are drug companies already have G-10s on other products.
If you don't like this solution, you might the NDC in secondary
information.  We have primary information which is the G-10, the
product, the data structure that is in the barcode, secondary
information like lot expiration date could be an NDC in there.  It could
be an application identifier.  We already have national stock numbers as
a separate AI.

	We also suggest that, if you do this, that you grandfather the NDCs
that are already there and UPCs because they are already there.  Why
change them?  Why have someone relabel an NDC.  But, going forward with
your regulation, we suggest you just go to a G-10.

	Also, as we always say, you should engage the GS1 global-user groups.
I am a staffer from G1.  I can tell you what the standard is.  I can
tell you how it works today.  I don't make it up.  The users get
together and decide how the standard works.

	There are several groups right now.  One is the healthcare users group.
 It is a global user group because we are having these issues in other
companies globally in healthcare because the healthcare issues have been
raised again and again.

	If you go to G-10, I think it will continue to allow your FDA goal for
unique identification of all products to meet it.  We have very strict
rules.  We are a rule-based organization.  Each packaging size has to
have a different G-10, just like a different NDC.  We have worldwide
compliance with our GS1 standards.  Also, we think if you go with the
G-10, rather than marking an NDC in the product, you stop other national
ministries of health looking for their own national requirement.

	Within the last year, we have had three governments come in looking for
their own NDC, if you will, on their own products within their own
country.  This causes problems for the manufacturers because they have
to ship an NDC into the U.S.  But, for Italy, they have to ship
something else, for Germany something else.  There are examples.  That
is not happening right now.

	One example is the Italian example.  If you are a manufacturer, you
ship any drugs into Italy, you must use a serial number.  You have to
get a serial number and barcode from the Italian Ministry of Printing
from Italy.  If every country did like this, this would really disrupt
the smooth flow of healthcare products throughout.

	It also could create possible errors.  How could it?  If you have two
barcodes.  If you had a commercial barcode on the product, a UPC so it
could be scanned and moved forward and you had another barcode with the
NDC.  We have seen this in other countries.  The nurse is confused,
which one do I scan.  It causes problems in the database.  Also, what do
you load in the database?  Do you load the G-10 or the NDC?

	I went very quickly.  That is our overview.  For GS1 US, we are a
standards organization, global.  We are in 155 countries.  There is
roughly a million members, 280,000 within the United States.  18,000 say
that they are in healthcare.  A lot of our marketing material says we
scan 5 million times a day.

	If you do the math on that, that is roughly 200,000 scans of a barcode
an hour, 3,000 a second.  A lot of information being processed very
quickly throughout the entire system.  We are a voluntary in the United
States, not-for-profit, not government but member driven.  Understand
what drives the entire system is members look at it and decide what is
the best as we move forward.

	It has been said in some of the earlier presenters that the barcode is
only one part of the picture.  The barcode is scanned.  It goes into a
database.  That is something that the FDA must remember when they go
forward with this.  The barcode goes into database.  It is a pointer to
the database.  The barcode has no information to it.  The NDC is the
only variation within our system where it actually has logic written
into it for the NDC.

	Most of barcodes are dumb numbers.  Everyone likes dumb numbers because
they just point to the database.  We encourage the FDA to adopt this.

	Why would a move from 10-digits to 11-digits concern us?  Our system is
very structured.  A UPC is 12 digits.  It has been 12 digits since the
1970s.  All the databases are built on this.  The scanners are built on
this.  In the 155 countries where we are giving numbers out to
companies, everything is built on this so we don't have a collision.

	In summary, real quick--I haven't used my entire time but I did use ten
minutes--we suggest that you decouple the NDC number from the barcode.
If you want the item barcoded in there, you could use secondary
information or require a G-10 in there.  We think that dumb numbers are
the best.

	Adopt at GS1 commercial global standard.  That way products can be
shipped throughout the world without these variations in country rules.
We think this will avoid potential errors, avoid the charges of a
U.S.-centric system and will be able to influence the global standards
as we move forward.

	Again, GS1 US appreciates the opportunity to speak at this forum.
Thank you.

	MR. BERNSTEIN:  Thank you.  Any questions from the panel by way of
follow up?

	MR. LEVIN:  I have a question.  Who assigns the G-10 number?

	MR. ROBERTS:  The question is who assigns the G-10 global-trade item
number.  A company comes in, pays a fee and they are assigned a labeler
code.  Similar to your NDC labeler code, we assign a company prefix
code, variable length.

	MR. LEVIN:  So it is assigned similar to what the NDC has done now.

	MR. ROBERTS:  Correct.

	MR. LEVIN:  Can the NDC be used in the G-10?

	MR. ROBERTS:  Yes; it can, in its current configuration.

	DR. GARDNER:  Can you explain that a little bit as to how that--the UPC
is 12 digit.  The first digit is product category and the last digit is
a check-code.  So you have 10 digits in between that we use the current
NDC number; is that correct?

	MR. ROBERTS:  That is correct.  I haven't been in GS1 from the start,
but in the 70's, according to the books, the FDA and UCC, at the
time--actually Uniform Grocery at the time--got together and determined
how to put this together.  The UPC's 12 digits for NDCs and the NHRIC's
number, when you came in with a labeler code, we put a 3 in front of it
so when you pick up an aspirin or something like that, the 3--in our
system, the next 10 digits is either an NDC or an NHRIC number.

	We don't look at how it is configured.  We just give the labeler code.
We also go back and check with the FDA to make sure that that company
does have that code.  We want that piece of paper from you assigning
them or, from the NHRIC, we want a piece of paper because a lot of
companies come in, they like that NDC for all the reasons that you folks
talked about for payment.  It is keyed on something that wasn't part of
our standard originally.

	DR. GARDNER:  If we had to standardize on 10 digits--maybe others could
comment on if we had to standardize on 10 digits--would it simplify
things if we went to a common standard of 5,4,1, for example?  Does it
matter for your--

	MR. ROBERTS:  It doesn't matter.

	DR. GARDNER:  For other people, it might matter a lot.  The conversion
from 10 digits to 11 digits is somewhat complicated because of all the
different standards and confusion.  So all the billing systems, not the
UPC billing systems but the drug and Medicare-Medicaid reimbursement
billing systems, are, I guess, filled by the NCPDP standards convert to
11 digits.

	If we set up a standard way to convert from 10 to 11, would that--like
I said, 5,4,1--would that solve your problem?

	MR. ROBERTS:  I think the question is if you had a standard conversion.
 As long as you retain 10 digits, and digits not alphas, then we
wouldn't have any problem with a barcode system globally.  When you go
to 11 digits, when we have huge difficulties.

	How do we assign numbers?  How does it fit into a 12 digit?  You just
can't do it.

	DR. GARDNER:  I guess that is the other issue.  Is it necessary to have
the NDC in the UPC or is there another way to do that?

	MR. ROBERTS:  As I said, before the Barcode Rule of 2004, a lot of the
over-the-counter drugs just had a UPC in it using the company prefix
that they were assigned in the UPC.  With the 2004 barcode, they
switched and put their NDC in there.

	Has there been any change to the marking system?  No; the barcode is
still scanned.  The G-10, that is what we call that number in there in
the UPC, is scanned, points to a database and moves on.  We don't see
any difference why does the NDC have to be.  We applauded the idea at
time.  We thought it was a good idea just to move healthcare forward
because we have been trying to get everything marked for years.

	But now, as we are moving forward, we are seeing other global issues
with it.

	DR. GARDNER:  Can you talk a little bit more about the impact of having
two barcodes, then, one for the NDC and another as a UPC?

	MR. ROBERTS:  The impact would be--and then you really need nurses and
pharmacists in here.  This is all anecdotal evidence that I have heard,
a lot from the V.A.  They send us all their packages where some of our
manufacturers go against the standard or they can't read the barcode.
There are a lot of instances where they have had two barcodes on the
package.  The nurse is confused.  Which one does he or she scan?

	If they both look like UPCs, they scan them twice or they scan the
wrong one first.  A lot of times, there are label numbers or they scan
the lot-expiration date before the primary information G-10.  It fouls
up the system and creates errors.

	Also, say, for instance, there was a commercial G-10 in there in the
UPC and the NDC.  If the nurse scanned the commercial G-10 and it wasn't
in the database, you would get a "not find."  If you scanned the NDC and
that wasn't in there, then you would get a "not find."  So they have to
scan both.  So it could be that they scanned both and then you had a
double reduction from the inventories which has occurred in the past.
It creates duplication and error.

	I see I have lost most of you.  Sorry about that.

	MR. LEVIN:  Another question.  The G-10 is specific to the package?

	MR. ROBERTS:  Yes; the global-trade item number changes as the package
size changes.  If you will, the UPC on that bottle is different from
this bottle.  It should be different than a package of six or a case of
12.  For inventory purposes, you have to know what you are buying.

	MR. LEVIN:  Some people use sort of 9 digits to look at just the
product and disengage the packaging.  Do have anything equivalent for
that?

	MR. ROBERTS:  No; I don't.

	MR. BERNSTEIN:  Thank you.  Next up is Diane Servello from Watson Labs.

	MS. SERVELLO:  Good morning.  I am Diane Servello with Watson
Laboratories.  I am the Director of Generic Regulatory Affairs.  My
department is responsible, among other things, for drug listing,
assignment of NDC numbers for the company as well as preparing SPL
labeling.

	I want to thank the agency for giving me the opportunity to present
Watson's concerns with the proposed regulations.  In the August press
release, the agency stated that having drug makers submit drug
information electronically will help keep an accurate, up-to-date
inventory of drugs on the market and will maintain more accurate
information to make it easier to respond to drug emergencies such as
recalls and drug shortages.

	Watson fully supports the submission of drug-listing information
electronically.  We agree that submitting drug-listing information
electronically is an improvement over the current paper system and will
help to improve the accuracy of drug-listing information.

	However, we disagree with the proposal that FDA assign NDC numbers.
There are a multitude of reasons why firms should be permitted to
continue to assign their own NDC numbers.  I will provide five examples
today.

	Number one.  Watson is a drug manufacturer as well as a private-label
distributor.  We manufacture many of our own products but also use
contract manufacturers to produce some products sold under the Watson
label.  Watson owns the NDA or ANDA for some of these
contract-manufactured products.  In this role, we are responsible for
many of the activities that the proposed rule does not contemplate such
as determining the trade dress for the product in the R&D stage.

	At the R&D, table or capsule imprint markings are assigned, which are
based on the product-code portion of the NDC number.  At this early
stage in the product development, the determination of the ultimate
manufacturing site for the commercial product may not yet be made.  Yet,
we still need the product-code number to finalize the trade dress. For
this reason, the proposal that NDC numbers be assigned to manufacturers
instead of private-label distributors is problematic.

	Number two; because NDC numbers need to be assigned very early in the
R&D process, Watson has already assigned numerous NDC numbers for
products in our R&D pipeline that are not yet drug listed.  We have
already ordered tablet tooling utilizing these product-code numbers.
How is FDA going to avoid reassigning these numbers to other products if
they assume responsibility for assigning numbers.

	Due to the size of Watson's product line, we currently market products
under different labeler codes.  This is done to separate our various
business units.  The proposal to use only one labeler code for any new
NDC numbers assigned by the FDA would disrupt our business process.

	Number four; currently, Watson does not use different package codes for
each level of packaging.  To change this practice would cause a major
disruption in our business processes by causing us to reconfigure the
business software we currently use to control our manufacturing,
packaging and distribution processes.

	Number five; NDC numbers are used as identifying codes for a myriad of
other activities including interactions with other governmental agencies
such as the DEA for Arcos reporting and various agencies for
Medicaid-Medicare reimbursement.

	In addition, many firms use 10-digit NDC numbers to track their own
internal business processes and/or documentation such as manufacturing
records, analytical test methods, validation reports, et cetera.  Any
changes to the current system will cause major disruption to these
processes.

	As stated previously, Watson fully supports the electronic submission
of drug-listing information.  We believe this is significant improvement
over the current system and will improve the accuracy of the data
contained in the system.  However, the proposal for FDA to assign NDC
numbers will cause major disruptions in our business processes.

	We advocate allowing firms to continue to assign their own numbers
according the current practices.  We believe the agency could devise an
electronic system that allows firms to enter their own information while
still accomplishing the goals of the proposed rule.

	Thank you for the opportunity to present my concerns.

	MR. BERNSTEIN:  Any follow up for Diane?

	MR. LEVIN:  Yes.  I have a few questions.  How early in the process do
you assign the NDC, how much time before you go to market, would you
say?

	MS. SERVELLO:  I would say it is sometimes three or four years before.

	MR. LEVIN:  So if the assignment is made three or four years before,
that would accomplish what you need.  Would that accomplish what you
need?

	MS. SERVELLO:  I think that one of our concerns, and I didn't mention
it, is the time factor, too, because if it is a process where we have to
apply for it and then wait 60 days for it, I don't think that is going
to allow us the flexibility we need and what we have under the current
system.

	MR. BERNSTEIN:  What time factor would be acceptable?

	MS. SERVELLO:  I would like at least five working days.  I get 20
minutes to do it right now.

	MR. LEVIN:  you said there was a problem with assigning the numbers,
duplicate numbers, or whatever.  How do you avoid assigning those?

	MS. SERVELLO:  I assign numbers currently through an access database
where I have all the possible numbers that are available.  If that spot
is blank, then I have that number available.

	MR. LEVIN:  When you were talking about the different business units,
can you elaborate on what those business units are for the different
labeler codes?

	MS. SERVELLO:  Watson currently has a branded division and a generic
division.  For our generic division, we use a 4,4,2 configuration.  For
our branded division, we use a 5,3,3 configuration.  We also just did an
acquisition.  That division is going to maintain their labeler code so
that is another division that requires another labeler code.

	MR. LEVIN:  So, through an acquisition, you are going to keep them as a
separate entity at least inside of your company.

	MS. SERVELLO:  Yes.

	MR. LEVIN:  You talked about the level of packaging.  What level of
packaging do you assign the NDC?

	MS. SERVELLO:  We assign the NDC number for bottled products.  But it
is the case quantities that we don't assign a level at this point,

	MR. LEVIN:  So you assign it for the bottle but not at the--you have a
case of 12 bottles. not at that level.

	MS. SERVELLO:  Yes.  Even for injectable products, we would assign it
for the carton that contains the vials but not the outer shipping case.

	MR. LEVIN:  Okay.

	DR. GARDNER:  Can I follow up on a few more of these?  As we are
currently contemplating, we would have the company submit the NDC number
they want and then we would not accept that only if it didn't meet
formatting requirements or was duplicative of another product.

	It is possible, because of the 5,4 labeler code configuration that,
when you collapse 11 digits to 10, you get a duplicate.  You would never
know that within your company.  But, within your company, with your
labeler code, you would have total control over your own product codes
and package codes, again, as long as they meet the requirements.  The
requirements will change.

	If you change the inactive ingredient, for example, or a significant
inactive ingredient, then it would get a new number, it would have to
get a new number.  Would that disrupt your business processes?

	MS. SERVELLO:  I don't think so.  As long as we could submit the
requirements, you would accept that number.

	DR. GARDNER:  There is no reason we wouldn't accept it I can think of
other than, as I mentioned, the formating stuff.  But, anyway, that type
of interaction--what I am getting at is if we continue to give the
companies control over the numbers they request, would that resolve most
of the issues you have brought up?

	MS. SERVELLO:  Yes.

	DR. GARDNER:  Okay.

	MR. LEVIN:  I have another question.  Coming back to your business
units, how do they function as far as operation in your company?  Are
they separate?  Do they have separate chains of command, contact people.

	MS. SERVELLO:  They are all subsidiaries of Watson Pharmaceuticals, but
they do operate--the branded side and the generic side operate as
different divisions of the company.

	MR. BERNSTEIN:  Thank you very much.  I guess we seem to keeping the
trains running on time this morning.  We have a break scheduled until
10:45 and then we will pick up again with additional speakers.

	[Break.]

	MR. BERNSTEIN:  We will move right back into the speakers.  The next
speaker is Dr. Thomas F. Willer who is with Hospira.

	DR. WILLER:  My name is Tom Willer.  I am the Director of Regulatory
Affairs at Hospira.  I would like to focus my comments on legacy, NDC
numbers and compliance.

	As noted here, the National Drug Code numbers are one of the linchpins
of the healthcare system.  NDC numbers are used throughout the
drug-supply chain and users extend from pharmaceutical companies,
distribution system, medical community, insurance industry as well as
the government, itself.

	Currently, NDA and ANDA holders assign NDC numbers for the product code
of their own products.  This has been the case for decades and is deeply
embedded in the internal processes of sponsors specifically and the
healthcare system in general.

	The NDC number is not only used for marketing purposes.  It also plays
a pivotal role for sponsors and the R&D process where the number is
crucial for internally tracking compounds in a company's pipeline.  As
noted by one of the earlier speakers, the R&D process begins years
before a product is launched.  Therefore, under the current
recommendation by the agency, the NDC number would have to be applied
for and granted years before a product launch or before an ANDA or NDA
approval.

	The NDC number is also used in identifying the export of scheduled drug
compounds for DEA.

	Now as noted by earlier speakers, the August, 2006 proposed rule
contains the key NDC-related points noted in this slide, namely
universal standard format, drug-industry requests new NDC numbers.  FDA
signs them.  Current NDC numbers remain unchanged provided these numbers
comply with the new rule when finalized.  Lastly, non-compliant NDC
numbers would be reassigned by the agency.

	NDC numbers have been used for decades.  The FDA has accepted these
numbers via its drug-listing function.  The FDA has not routinely
contacted companies requesting changes to currently used NDC numbers.
Existing NDC numbers are already accepted, a critical part of the supply
chain, and being interwoven with both public and private healthcare
organizations.

	The proposed rule intimates that some unknown number of NDC codes may
not be correct.  This raises some questions.  For example, how many NDC
numbers currently exist?  How many does the FDA estimate may not meet
the 21 CFR 207.35?  In other words, how big is the problem, or potential
problem?

	Again, we are talking about thousands of drug products and legacy NDC
numbers.  Creating NDC numbers for various levels of packaging, as
noted, for the container, carton, as well as the shipper or corregate
increases the universe of NDC numbers, increases FDA cost to assign new
numbers, increases FDA cost to record and monitor new numbers and
seemingly has no additional benefit to patient safety.

	So it is not clear how the shipper NDC number has any effect on the
actual patient.

	Current distribution systems are already based on existing NDC numbers.
 An NDC number changeover could cause drug shortages as companies
navigate expiration of products with legacy NDC numbers and introduction
of products with revised or new NDC numbers.

	Tens of millions of dollars to the pharmaceutical industry would be a
cost as well as healthcare enterprises is an understatement.  This is
especially distressing in light of the increased cost of healthcare and
financially strapped hospitals and medical service providers.  In this
end, the burden ultimately will be born by patients.

	First and foremost, industry needs to know what  criteria will the FDA
use to judge legacy NDC numbers for compliance.  From a legacy
standpoint, there are thousands of products which fit the compliance
criteria over the decades.  For instance, the FDA approved Hospira's
first NDA in 1946.  The FDA has not notified the company of any
compliance issues with any NDC number in the past 60 years.

	Massive changes to the NDC system would require a much longer
implementation period than the proposed three years and nine-month time
frame.

	Two issues to consider, if there is a compliance issue to reassign NDC
numbers from numbers currently meeting the needs of the marketplace.
For example, many infusion devices already read barcodes or NDC numbers
would have to be recoded one by one.  An infusion device is a pump at
the hospital level.

	Also reprogramming and changes to databases by all parties is seemingly
not a productive use of limited funds and may disrupt reimbursement as
well.  A change to the existing NDC rule would cause a heavy burden on
the pharmaceutical and medical providers.  The internal processes and
systems would have to be reevaluated and changed.

	All parties in the supply chain incur costs from  manufacturers,
warehouses, distribution centers, medical offices, hospitals to
insurance and other reimbursement parties.  A unique package-code system
encompassing every company seems daunting since there are only two
digits available for the multitude of packaging configurations.

	If current legacy NDC numbers that meet market needs are retained,
progress to the proposed new FDA allocation of NDC numbers can easily
proceed.  We also strongly urge the FDA to put in place a robust
security system to protect sponsor confidentiality when requests are
made for a new NDC number.  As noted earlier, this occurs early in the
R&D phase of a company and we need that number and not let anyone know
that is has been allocated.

	As I have discussed, this isn't simply a matter of an NDC number.  This
is an issue that could include barcoding and reprogramming.
Consideration of expanding currently used barcodes would not produce the
dislocation issues of requiring new changes to NDC numbers with the
current market products.

	Company mergers and acquisitions; how will the agency handle these
frequent occurrences and the NDC implementation time?  System learning
curves which involved initial glitches and breakdowns occur.
Reprogramming NDC numbers in all computer databases throughout the
supply chain inevitably would be slow.

	Pipeline confidentiality, as I have mentioned, and delay of new product
launch and marketing, allocation of the NDC number must be confidential
and must be allocated in a timely fashion.  As noted earlier, a five-day
period or a 30-day period would probably meet our needs.

	A finite pool of numbers for an infinite amount of number
configurations, we see the number of NDC numbers as limited and not the
100,000 number or pool that the FDA projects.

	In summary, we urge the agency to consider retention of all current
legacy NDC numbers in the marketplace.

	MR. BERNSTEIN:  Thank you.  Any questions for Dr. Willer?

	MR. LEVIN:  Moving forward, then, for new products, following a set up
rules, do you have issues with that?

	DR. WILLER:  We support the idea.  Our only worry is how can the FDA do
it?  Right now, we have a 4,4,2 code.  So the first four of the label
code, they are gone.  The next four are the drug code.  There are only
9,999 numbers.  So Hospira already has allocated about 3500 of those
numbers.  So when the agency gets ready to allocate our next NDC number,
they have to know what has already been used up, at least in those four
digits for us.

	I don't know how you will do that.  Now, maybe as the NDC numbers
become more mechanized under Dr. Gardner's system for drug listing,
maybe that will be easy to manipulate and to understand.  If that is,
then that is good.

	DR. GARDNER:  So you don't think 100,000 unique numbers for Hospira is
enough?

	DR. WILLER:  I don't know where the number 100,000 comes from?  There
is 4,4,2.  You only have four numbers.

	DR. GARDNER:  That is 10,000.

	DR. WILLER:  Yes.  That is not enough over the long term.

	DR. GARDNER:  That is because you use two for a package code.

	DR. WILLER:  As mentioned earlier, the agency wants a number for
products going outside the United States.  We assign under that
packaging code a unique country destination.  So we have a specific
number for Ireland or for Germany or for ex-U.S.

	DR. GARDNER:  So if you ran out of product-code numbers, then a new
labeler code, would that solve your problem?

	DR. WILLER:  Correct.

	MR. LEVIN:  I have a question about what you just said about that you
used different codes for different countries.

	DR. WILLER:  Correct.

	MR. LEVIN:  Can you tell me more about that?

	DR. WILLER:  We manufacture some products for export here in the United
States.  In order to keep it clearer at the manufacturing site, we want
to assign--we have assigned a unique NDC number to follow that product
during the manufacturing stage so that if the product formula for Italy
was different than the one for the United States, we would make sure
that that number is associated with that product.  So it is a security
issue.

	DR. GARDNER:  The product formulation or packaging?

	DR. WILLER:  The product formulation.  It could be packaging but it
more likely is formulation.

	DR. GARDNER:  But if it is formulation, it would have to have a
different product code.

	DR. WILLER:  Under the proposal; yes.

	DR. GARDNER:  That is current.

	DR. WILLER:  Yes.

	MR. LEVIN:  But some of these products are the exact same formulation?
You are just sending them to different locations?

	DR. WILLER:  Correct.

	MR. LEVIN:  Then you assign another product code for your own internal
purposes.  These are never made public, these numbers.  They are never
used.  Am I misunderstanding that?

	DR. WILLER:  I am not an expert on exporting of drugs so I don't know
for sure.

	MR. LEVIN:  Okay.

	MR. BERNSTEIN:  Thank you.  Next up is Scott Melville from the
Healthcare Distribution Management Association.  Following Mr.
Melville's remarks, we should have some time for some discussion if
there are any audience questions.  If you don't want to use the
microphone, you can also write them down and send them up here.

	MR. MELVILLE:  Thank you and good morning.  I am Scott Meville.  I am
Senior Vice President of Government Affairs for the Healthcare
Distribution Management Association.  I commend the FDA for holding this
important public hearing this morning.  I thank you for the opportunity
to comment on behalf of HDMA and our members.

	HDMA represents the nation's primary full-service healthcare
distributors.  Our 40 members include large national companies and small
regional family-owned businesses.  Each day, our members deliver 9
million healthcare products to more than 144,000 pharmacy sites across
the country in all 50 states and U.S. territories so there is a lot of
volume going through our members on any given night.

	HDMA supports the FDA efforts to clarify the regulations on drug
establishment, registration and listing in much of the proposed rule.
However, there are two critical parts of the proposed rule that will
have an enormous and very negative impact on our members in the
pharmaceutical-supply chain.  Those two areas are the definition of
relabeling and the assignment of NDCs on new packaged drug products.

	With regard to relabeling, the FDA's proposed definition of relabeling
in Section 207.1 is defined very broadly to meet any change or addition
to the label or labels on a drug or drug package.  HDMA has grave
concerns regarding the breadth of this definition.

	HDMA distributors, as I said, ship millions of prescription drug units
each night to customers across the country.  To do so efficiently, it is
common practice for our members to affix stickers, barcodes, tags or
other identifiers to drug packages to track inventory location, identify
product origins and/or ensure proper returns from pharmacies.

	For example, stickers may confirm or convey important handling
information for customers such as "refrigerate upon arrival" or direct a
delivery of drugs to a particular part of the hospital or medical
facility.  Some distributors manage inventory by applying proprietary
serialized codes to drug packages that enter their facilities.  These
additions allow a company to identify and trace the drugs entering and
leaving the distribution center.

	Some distributors also apply codes to drug products in order to
efficiently and effectively comply with the FDA's barcode rule.
Requirements under the PDMA final rule and/or state drug pedigree laws;
to improve compliance with the State of Florida's recent pedigree law,
for example, some HDMA members add serialized barcodes to the
drug-product container.

	Currently, also, some distributors participate in radiofrequency
identification pilots to study the use of RFID tags in the
prescription-drug supply chain on appropriate products.  As RFID
programs further develop, distributors will need the flexibility to
sticker or tag products without also triggering the listing or
registration requirements of this rule.

	I have an example of a very simple tag that many of our members use,
but this is an example of a type of a tag a distributer might put on the
bottom or side of the bottle when he sends it out to his customers.  It
explains where the product should be returned to or reordered from.

	I also have a photo here of a license plate, essentially, a code that a
distributer may affix to the bottom of a product.  This is an example of
what one distributer is doing to comply with the state pedigree
requirement to be able to track a unit of that product since, as of now,
most products coming from manufacturers are not serialized.  They simply
have a lot number and an NDC number.  Many, many pedigree laws require
them to get down to the unit level.  So there is some additional marking
that is necessary to comply with those laws.

	These examples of distributer-applied stickers and tags do not
otherwise alter the drug's original label, labeling, package or outer
container.  They do not affect the safety, purity of potency of the drug
and do not disturb its existing packing configuration in any way.

	Thus, if the definition of relabeled remains as proposed, many common
security and inventory tracking best practices conducted today by
distributors would, we believe, unintentionally trigger the relabeling
designation and requirements of this rule.  If left unchanged, FDA would
have to assign tens of thousands of new NDC numbers to ensure
compliance.

	Given that the agency stated in the rule's preamble that most drugs
would be able to retain their current NDC number, we believe FDA did not
intend these consequences.  In our written comments, we will propose an
alternative definition of relabel that we believe both accomplishes
FDA's goals and permits continuation of common distributor stickering,
tagging and barcoding practices.

	The second issue with which HDMA would like to discuss today is
repackaging.  We believe this is a practice that would be significantly
affected by the proposed rule.

	HDMA members perform many forms of packaging.  For example, a packaging
company may simplify the last step in the manufacturing process such as
contract processing or aid in the dispensing of products to the patient
for use for unit-dose systems such as unit-dose packaging in hospitals.
However, today I will limit my comments to the proposed rule's effect on
another type of packaging known as retail-service repackaging, a
practice that was earlier discussed by the National Association of Drug
Stores representative John Coster.

	A retail-service repackaging company purchases finished solid oral
dosage-form drug products from the manufacturer and repackages them into
smaller quantities.  The smaller packages are sold and delivered to
retail pharmacy customers bearing the manufacturer's applicable NDC
number for that package size.

	Retail-service repackaging safely and effectively offer package sizes
that increases inventory efficiencies, eliminates waste and provides
enormous value to our members' retail pharmacy customers.

	HDMA members who conduct retail-service repackaging do so in a safe,
secure environment.  All repackaging companies must register with the
FDA as a manufacturer and operator in strict adherence with current good
manufacturing practices.  In addition, repackaging companies must be
licensed as distributors under applicable state laws.

	Further, our repackaging members include their name, address and
repackage lot number on each and every repackaged drug product enabling
the product to be tracked back to the repackager and ultimately the
original manufacturer.

	Above and beyond these regulatory requirements, HDMA has established
recommended guidelines for pharmaceutical distribution-system integrity
and recommended guidelines for pharmaceutical repackaging integrity.
HDMA's repackaging members also voluntarily and independently follow
even more aggressive security policies including those that require that
they purchase the drug products directly from the manufacturer of the
product, itself, the original manufacturer.

	The proposed rule would disrupt the safe, efficient and cost-effective
business service by requiring a new repackager NDC on the product.
Under CMS requirements, responsibility for payment of the Medicaid
rebate follows the NDC number on the drug package.  If the
manufacturer's NDC number appears on the package, it is responsible for
the rebate payment.

	If the repackager's NDC number appears on the package, the repackager
is responsible for the rebate.  By requiring that retail repackaged
drugs bear the repackager's NDC number, the rule effectively shifts the
burden for Medicaid rebate payments from the manufacturer of the product
to the repackager.

	To better understand the business implications of this shift, NDC
retained the Moran Company, an independent consultant firm.  Their
analysis concluded that repackaging companies will not be able to absorb
the rebate cost given the industry's traditional slim profit margin.  If
the proposed rule becomes final and repackaged drugs must bear the
repackager's NDC number, the consultant confirmed that distributors will
no longer be able to offer this valuable service to pharmacy customers
and will exit the retail-service repackaging industry.

	Considering the economic impact and safety and security controls
already in place, requiring a new repackager NDC number, we believe, is
not warranted nor will it provide additional levels of security.
However, if FDA is convinced that an additional identifier is needed, we
believe the alternatives that HDMA and NACDS have previously described
to the FDA are still valid and will satisfy the rule's intent while
allowing the repackaging industry to continue to serve it's pharmacy
customers.

	Given the significant impact of the proposed rule, we ask that the
agency reconsider those alternatives.  Either one would formalize the
application of the unique repackage item code and would meet the FDA's
objective of further identifying the repackager and repackaged product
without requiring a new NDC.

	We hope FDA will seriously consider the implications and alternatives
presented by NACDS and permit a path forward that enables our pharmacy
customers to continue to benefit from repackaged products.  If, however,
FDA proceeds with implementation of the rule, NDC may ask, on behalf of
its members, that the agency allow sufficient time to orderly structure
the retail-service repackaging operations.

	For prescription drugs, FDA had proposed a three to five-year
implementation period.  HDMA members estimate the pharmaceutical supply
chain will be five years to adapt to this new rule.  Repackaging
companies will need to renegotiate their contracts with both customers
and suppliers, change and phase out retail-service repackaging
operations and terminate or reassign work force.

	Our members pharmacy and hospital customers will need time to evaluate
their supply options and locate alternative sources for the product they
obtain from retail-service repackagers.  Finally, manufacturers, some of
which rely on repackaging to meet pharmacy needs, will require time to
alter their operations and possibly increase their own packaging
capacity to produce additional smaller units for distribution to retail
pharmacies.

	To conclude, HDMA appreciates the opportunity to share views with the
FDA.  We commend the agency for proposing a rule intended to improve the
quality and timeliness of information available to patients and
healthcare professionals but we believe the proposed definition of
relabel would undermine those stated goals by adding a more complex
numbering and relabeling process into the current distribution system.

	We ask that the agency carefully examine the proposed definition of
relabel and narrow it to permit barcoding, tagging and other stickering
practices distributors use to ensure a safe and secure delivery of
products to their pharmacy and other healthcare-provider customers.

	Second, we ask the agency reconsider its proposal to require that
repackagers use their own NDC number and, instead, allow the continued
use of the manufacturer's NDC.  If the agency chooses not to amend the
proposal as we recommend, we urge full consideration of the implications
to the entire pharmaceutical supply chain by allowing the five-year lead
time needed for manufacturers, repackagers and the retail industry to
make alternative arrangements.

	I thank you for the opportunity to provide these comments today.

	MR. BERNSTEIN:  Thank you.  Questions?

	DR. GARDNER:  The repackaging issue, it sounds to me like this is
primarily a rebate issue.  This repackaging item code--is there a need
to have two separate codes on there, an NDC and a repackaging item code
rather than just a different NDC number?

	MR. MELVILLE:  Certainly, the NDC number is key to determining who pays
the rebate.

	DR. GARDNER:  Aside from that question, is there any reason to have two
different identifications numbers?

	DR. WILLER:  No; absolutely not.

	DR. GARDNER:  So it is really a rebate issue.

	DR. WILLER:  Yes.

	DR. GARDNER:  And that is, to me, a separate issue.  That is a Center
for Medicare-Medicaid Services issue as to how they manage their rebate
program rather than a unique product-identifier issue.

	DR. WILLER:  Let me alter that answer a little bit in that, if it is
truly the intent of this rule to identify the origin of the product,
then the NDC number on the bottle with the repackager's current
identifier, the practice of placing the repackager's name on the label,
that is the addition that a repackager product adds.  It is required to
add "repackaged by" on that label.

	So you have the NDC number, the manufacturer of the product.  Then you
have, in human-readable form, the repackager's name.  You are able to
identify who repackaged that product and that repackager is able to
identify, obviously, the source of the product, the source being the NDC
number that is on that bottle.

	DR. GARDNER:  But the new NDC number for the repackager would serve the
same purpose as having that RIC? number.

	AUDIENCE:  [Chorus of no's.]

	DR. WILLER:  I hear the people in the audience do not agree with that.

	DR. GARDNER:  I am asking.

	DR. WILLER:  Perhaps that could be during the question-and-answer
session.  It would not serve the same purpose because, under the current
Medicaid rebate rules, the manufacturer--

	DR. GARDNER:  There are two separate issues here.  One is the unique
identification of the product.  We go by NDC.  Does that RIC serve
another purpose that would not be met by having a new NDC number is my
point, other than the rebate issue.

	DR. WILLER:  Oh.  Sure.  I think the agency is required to consider the
economic implications of every rule that it undertakes.  By going and
putting the repackager's NDC number on, you would essentially put that
industry out of business.  So, by keeping the old one on with a RIC, the
industry could continue to provide the benefit to its customers and, at
the same time, provide that additional level of identification that it
appears the FDA may desire to have.

	DR. GARDNER:  I am not saying that we would tend to interfere with the
rebate process.  That is certainly not what we are doing.  What I am
saying is there are two issues here.  One is the unique identification
of a product which, in our current thinking, that should be by NDC
number.  But a second is the rebate issue which is an issue with CMS,
not with us.  But we certainly would get it worked out before we went
forward.

	DR. WILLER:  We recognize that the NDC number that goes on the
repackaged product to the customer is the NDC number for that exact
product that that patient or that customer is receiving.  It is the
manufacturer's product, so everything that is in that NDC label that
describes that product that is in that bottle.

	They are repackaging the manufacturer's branded product and putting it
in a bottle.

	DR. GARDNER:  I understand that but the repackager is, by definition, a
manufacturer.  They've changed the product.  So that manufacturer needs
to be identified in our listing system as having touched or dealt with,
manufactured that product.  That wouldn't happen under--by using a RIC,
because we don't use the RIC in our listing.  We use the NDC.  So that
is what I am trying to get clarification on.

	DR. WILLER:  Our members do have to file listing for an NDC number.
The Chairman of our Packaging Committee, Tim Booth, is her.  Tim, do you
want to talk about your company's practice as far as the listing?

	MR. BOOTH:  My name is Tim Booth.  I am the Chair of the HDMA Packaging
Committee which we have several members, three larger members being the
wholesale distribution community.

	In the filing process, we do have to file with the FDA for drugs and
list drugs that we do repackage.  On the label for the branded
repackaging that we are referring to is the NDC of the original
manufacturer.  We do, however, list with the FDA with our own NDC number
for that repackaged drug in the listing process.  Therefore, we have
complete traceability from the original drug, the original manufacturer,
to the repackaged product, very clear traceability, both through the
listing process and also in our systems that we use to track the drug
from the purchasing to the actual sales side of the business, complete
traceability.

	Does that answer your question?

	MR. LEVIN:  Again, it seems like it is this rebates issue, which number
is on there.  That is the main issue.

	MR. BOOTH:  That becomes a thrust of what is--by changing NDC number,
that becomes the thrust of the issue for our business; correct.  But,
from a traceability and product standpoint, we have complete
traceability from the original manufacturer, and we do buy from the
original manufacturer directly, to the actual repackaging process to the
sale of the drug through to the retail pharmacy, complete traceability
in both batch records of production, purchasing activity and the listing
process.

	MR. LEVIN:  The repackager item code, can you give me more about that?
I am sorry, but I don't know--

	MR. BOOTH:  The repackager item code that we are referring to is a
unique identifying number that we will assign to that specific product.
It is an internal number that we generate in our business practice that
we can identify that unique number.  So it is unique to every single
item with, in this case, the McKesson distribution-supply chain.

	MR. LEVIN:  It is unique in your own system.

	MR. BOOTH:  It is unique to our system; correct.

	DR. GARDNER:  So there would be a one-to-one match between the RIC and
the repacker's NDC.

	MR. BOOTH:  Yes.  Absolutely.  There is a unique connection between the
internal economos number, as we call it, the identifying number, the
repacker's NDC that we file and also the manufacturer's NDC number that
is placed on the label, a very acute connection there.

	MR. LEVIN:  So when you go through the listing process, you can
identify the NDC of the manufacturer that this is in your repackaging.

	MR. BOOTH:  On the listing process, we put on the actual filing the NDC
that we are filing for our product.  We also refer to the original
manufacturer on this listing process and the labeler code of that
original manufacturer.  So there is, again, a unique connection between
our systems.

	We also use those systems to actually create the pedigree for a product
that we are shipping out to Florida and to other states that require a
pedigree.

	Any other questions on that?  Did we answer the question sufficiently
for you?

	DR. GARDNER:  Yes.  Thank you.  Is this the last presentation of the
morning?  Let's just move to the open discussion.

	DR. WILLER:  Thank you very much.

	Open Discussion

	MR. BERNSTEIN:  Did anybody have any questions or comments from the
audience?

	MS. BENYO:  My name is Laurel Benyo from Ben Venue Laboratories.  We
are both a generic drug-product manufacturer as well as a contract
manufacturer for branded drug products.  I have three comments that
developed as I have been listening to the other speakers.  Thank you for
this opportunity.

	Number one, with regards to timing, you have been told over and over
again, we are the same.  Our R&D uses NDC number.  We assign numbers
approximately four years prior to the time that they actually reach the
market, ideally, if everything goes well.

	But there is also another timing issue that we have.  We do private
label.  We have received contracts from GPOs where we are expected to
launch in, like, a week.  I assigned an NDC number in 20 minutes, as
somebody else spoke.  So we would need very, very quick turnaround on
NDC numbers, the approval, because we are expected to do product
launches in a very timely manner when we do get contracts like this or
private labels.

	We do turn them around very quickly.  30 days would not satisfy some of
our private-label distributors that we try to launch immediately.

	The next comment is regarding 10 digits.  We are a small buy-in
parenteral.  The majority, about 70 percent of my drug-product labels
are 2 cc vial labels.  I have a great deal of difficulty currently with
the RRS barcoding that will be used.  We try to always use the 7 ml
barcode.  We have gone down the a 5.  This does cause difficulty.  We
want to make sure that our barcodes are always legible and easily
scanned by the end user.

	Adding additional digits would be very difficult.  Our unit cartons do
use the UPC.  I thank John Roberts for pointing out that it is a
12-digit number and that it would cause a great deal of concern if it
was to go to 11 digits.  We would no longer be able to use the UPC on
our cartons.

	Our final thing; we have a 5-digit labeler code so we have 5,3,2
configuration.  Our generic drug business has only been around for 14
years.  We have always used one-third of the available digits in that
middle three.  We have used over 300 numbers.  If you look at that, in
14 years, we do have a finite number available to us.

	I know the gentleman was talking about having 9,999.  But we only have
999 in that middle digit.  We have already used a third in 14 years.  So
we do see a finite possibility in how we manage our NDC numbers.  So I
respectfully request that we continue to allow industry and ourselves to
assign these numbers based on the need for timeliness, the need for
control.  It is a great deal of numbers.  You look at all of industry
and it would use a great deal of the FDA's resources.

	So thank you for this opportunity.

	MR. BERNSTEIN:  Thank you.

	DR. GARDNER:  Again, if you ran out of product-code numbers and we were
able to issue you a new labeler code, would that solve your problem?

	MS. BENYO:  It would from that point forward.  But then you have to
relate them together.  So we would have part of our product line using
our 5,5,3,9,0 labeler code.  Then you are going to switch in the middle
of our history to a new labeler code.  Whereas, if we are able to
continue to control them, then we can use--and we do assign new NDC
number to different formulations as they come through.

	I admire your use and restrictions that was put up by you at the
beginning.  Those are things that we comply to now.  If the proposed
rule continued to make industry comply with those use and regulations,
we do now and we would continue to do so.  But, yes; if you assign a new
labeler code, well, then, we would open up with another 999 digits in
the middle.  But you would be disrupting the history in the middle of
our list of numbers.

	MR. LEVIN:  I have a question.  When have you estimated that you would
run out of numbers?  How many years?

	MS. BENYO:  Currently, we file 12 ANDA applications every year with the
agency.  We have, on occasion, had 21 drug launches.  We average
approximately 10 drug launches a year.  So, like I said, in 14 years, we
are growing very, very quickly.  We started with one or two drug
launches a year and now we are going up to 10.

	In addition to that, we do private label.  We use our labeler code and
assign brand-new middle numbers for all of our private labels from GPOs.
 We have one drug product that we have four private labels in addition
to ours with three dosages.  So, right there, you have 15 numbers on
just one drug product.  So, given our past successes and a good hope for
the future, and we are already a third of the way in 14 years, then you
can just figure out that, hopefully, if this continues, we are talking
25 years.

	MR. LEVIN:  So 25 years from now.

	MS. BENYO:  Yes.

	MR. BERNSTEIN:  Thank you.  Did you have a comment?  Go ahead.

	MR. WRIGHT:  Thank you.  Good morning.  My name is George Wright.  I am
Vice President and one of the principals of Product Identification and
Processing Systems.  My company has a 25-year history of involvement in
the barcoding standards, development and implementation arena
particularly in healthcare.

	For the last 15 years, I have served on the Health Industry Business
Communications Council's Automatic Identification Technical Committee.
I am a certified solution provider for the GS1 system and, most
recently, served as editor of HDMA's new Barcode Implementation
Guideline.

	I would like to address a couple of comments on the NDC, its length and
the capacity of the system.  John Roberts did us a great service in
emphasizing that nothing beyond 10 digits in an NDC can be accommodated
within the present GS1 system.  It is not a question of you would like
to go to 11.  You may statutorily, of course, but it would completely
undermine the use of the UPC and the barcode rule as promulgated by FDA.

	So, from that perspective, and there is a great deal of detail behind
that--I don't think everybody wants to have their eyes glazed over here
for it.  My public comments in writing will cover this, but you cannot
go to 11 without completely disrupting the barcode rule as implemented
and the UPC system as used today at every level of packaging in the
United States.

	With respect to the capacity of the NDC system, on Page 85 and
elsewhere in your docket document, you talk about a capacity of 100,000
labeler codes.  On one page, in particular, on Page 85, you refer to the
possible confusion that would emanate from a labeler code of 1,2,3,4,5
followed by a 3,2 configuration with labeler code 1,2,3,4 followed by a
4,2 configuration.

	The age may have overlooked the fact the 30 years ago, you specifically
reserved code numbers 1000 through 9999 never to be used.  They cannot
be used or you would have exactly this problem you alluded to.  If you
go to the firms.text listing as published currently, you will find that
4-digit labeler codes cease at 0999 and only begin again at 10,000.

	There are two exceptions in the current listing.  I believe them to be
erroneously assigned codes, but 30 years ago, the way duplicates were
avoided was to set aside those 9,000 numbers from 1000 to 9999 never to
assign them.

	So there is, in my opinion, no prospect that there can be duplicates
within the current NDC system that you have 91,000 labeler codes
available for assignment and that that will meet the foreseeable needs
of this industry for as long as we are constrained by UPC.

	Thank you.

	MR. BERNSTEIN:  Thank you. Questions?

	MS. HORN:  Hi.  I'm Heidi Horn.  I work in regulatory affairs for the
Perrigo Company.  I first want to thank you for the opportunity to come
today and share ideas and open up a dialogue.

	I have a question as it relates to the filing of labeling
information--electronic labeling filing as part of the drug-listing
process as it relates to monograph products.  For ANDA and NDA products,
SPL labeling is part of the submission process.  But for monograph
products, SPL labeling is not a requirement today.

	So my question is will other electronic forms of the labeling be
accepted as part of the drug listing requirement?  Maybe now is not the
time to answer it.

	DR. GARDNER:  I think that would be answered in the final rule, but
that is an issue we need to determine for the XML SPL format that is
required for prescription application drugs.  But then we defined, in
the proposed rule, the content of labeling for over-the-counter drugs as
the drug-facts label.  We would develop a mechanism to do that.

	MR. LEVIN:  It might help if you put your question in the form of a
comment, turn it around.  What are the issues that you have.

	MR. HORN:  The issue would be that, for monograph products, electronic
form of labeling does exist.  But it doesn't exist in SPL format.
Therefore, manufacturers of monograph products, in particular Perrigo,
as store-brand manufacturer, we would have to create SPL labeling for
all of our products.  Annually, we develop 13,000 different labeling
components.  That is a lot of extra work.

	MR. LEVIN:  You said the labeling exists now.  Can you give us details.

	MR. HORN:  In electronic format?  Yes.  Today, the labeling exists in
Pediafile format.

	MR. LEVIN:  That labeling is also, I guess, in a word-processing
format, too?

	MR. HORN:  Yes.

	MR. BERNSTEIN:  I believe the preamble in the proposed rule
contemplates, at this point, use of sufficient PDF information other
than the specific exceptions that are named.

	MR. LEVIN:  Just in the comments; is that right?

	MR. BERNSTEIN:  That's right.  But I think those things are subject to
review as the process moves forward.  I don't know that anything has
been set in stone on that yet but I would point that out.  That is where
the proposal stands right now.

	DR. GARDNER:  The rule does state that we will submit a guidance that
would specify the format.  What that is has not been determined.

	MR. HORN:  I have another question that I will try to make a statement
this time around and that is as it relates to the labeling of monograph
products. I believe that it would your intention to post that labeling
also to be available to pharmacies and physicians.

	I guess my quandary or my concern would be that, with the monograph
products--labeling changes with the monograph products are primarily
driven by changes in the monograph.  If an additional warning was needed
on a monograph product, we would not necessarily have to request a new
NDC number and then subsequently file the revised labeling with FDA to
then be posted on the site and have you taken that into consideration.

	DR. GARDNER:  The current mechanism for posting labeling is the XML
format.  So, if it came in in XML format, we already have the capability
to do that, to post those.  If it didn't, then we would have to develop
a new capability and that would be a different process.

	MR. HORN:  Okay.  So it goes back to software.

	DR. GARDNER:  You can see the direction we are thinking.  Whether we
get there or not is not yet decided.

	MR. HORN:  Thank you very much.

	MR. BERNSTEIN:  Thank you, Ms. Horn.

	MR. LAY:  Good morning.  My name is John Lay.  I am the Director or
Regulatory for Apotex.  Currently, we have 68 applications pending with
the agency.  We currently follow about 45 annually.

	My question is, with that many applications, we use multiple
manufacturing sites.  Therefore, up to three sites, actually, will
produce the same drug and this is approved in the applications.  What
your rule is asking me, or directs me to do, is to produce the same
product, same formulations, at three sites and essentially have three
NDC numbers out on the market with my name on the product.

	I think that is going to--and after talking to the wholesalers, the
cardinals of the world, that is going to cause confusion from their
system because it is going to overburden their system by having to track
three NDC numbers instead of just one.

	That is one of the major concerns that Apotex has over this.

	MR. LEVIN:  Can I just have a clarification.  You said your company has
three different sites and you would different NDC for each site?

	MR. LAY:  Well, currently we would produce it under on NDC number at
three different sites.  Therefore, the cardinals McKessons would track
it accordingly.  By the rule, the way it is proposed, they would then
have to track three different numbers and actually have to order the
product depending on what number.

	DR. GARDNER:  That is not my understanding of what we proposed.  If it
is all within the same company, the site has to be listed but it would
not have a separate NDC number.  It is only if you are buying from
different companies that you would then have to have a different
number--

	MR. LAY:  That is correct.  If you use a contract--and that is my point
here--if you use a contract manufacturer to produce your product, it
will have another labeler code.  It will not have your labeler code on
it.  That is the point here is that the contract manufacturers product,
what they produce on your behalf, according to your ANDA that is
approved, or NDA, it will come on the market with multiple NDC numbers
for the same product.

	DR. GARDNER:  That is an issue we have to think about how to address
because the contract manufacturers, as a whole, are a grey zone.  If it
is clearly a different manufacturer you are purchasing from, then I
think it is clear.  But if it is within the same company, it is also
clear.  It is when you have a contract manufacturer that it is not so
clear.

	MR. LAY:  But what if the second or third manufacturer is located in a
different country; i.e., in India, as an example.  That is going to be
the same situation as a contract manufacturer.

	My next question is--it is a point and then a question--

	DR. GARDNER:  Back on that, I think that our public-health perspective
on this is that we need to know--if we want to trace a drug back to
where it was really made, if there is a problem and it has to be
recalled, or whatever, we need to be able to identify which product goes
back to which manufacturer and that is the thinking behind uniquely
identifying those products through the NDC code.

	MR. LAY:  I would agree with that except I do my recalls based upon my
lot numbers, not based upon an NDC number.  It is always lot-number
driven.  Really from a CMC's perspective, it is always lot-number
driven, not NDC driven.

	Now, another concern is, and I know there are numerous companies in
here that do the same thing as Apotex is I actually manufacture my
product according to an NDC number.  That is essentially my item number.
 So my NDC number does, in fact, go to a specified market for a specific
bottle size, whatever the case may be.

	My concern is I am going to change 2700 batch records to meet the
requirement so where my batch records, again, match my NDC numbers, that
could drastically change.  And the economic impact of that change is
enormous.  It really is.

	MR. LEVIN:  So you have multiple contract manufacturers.  Your issue is
with new NDCs for each one of those.

	MR. LAY:  The labeler code; yes.  And not even multiple contract
manufacturers but multiple sites and geographical locations throughout
the world that are, in fact, are approved to ship into the U.S.

	The next point I would like to ask, based upon the pedigree rule that
is now on a stay in the Eastern Port of New York, has there been any
conversation between the FDA and the states to try to alleviate the
conflicts of interest between the states or the conflicts between the
FDA and the states because the states do have, and the state
formularies, do have registration requirements that, if the states are
not involved in, we are going to go back into the pedigree requirements
right now that the FDA essentially told the states, under the PDMA rule,
that, here is the basic requirement.  You can add whatever you want to
it.

	So now I am dealing with 50 different egos of states, if you will, and
50 different requirements that could essentially be the same if the
states are not being advised by the FDA on what your requirements are.
And that is a concern again.  I have a pedigree staff that just monitors
the state requirements and the differences.

	MR. BERNSTEIN:  It is getting a little bit off the subject, but thank
you.  We will take it into consideration.  Anybody else have any
comments or questions that they want to raise?  Please.

	MS. ROBINSON:  Hello.  My name is Donna Robinson.  I am a regulatory
professional at Ranbaxy.  I just wanted to touch on the topic of
contract manufacture.  I wanted the agency to put to note that a generic
pharmaceutical company is required to file a supplement, a
prior-approval supplement if it is a contract manufacturer.  Therefore,
the system is in place to look at is this formulation the same.  Is the
equipment the same.

	Therefore, the need to change the NDC code may not be needed because
you still have that same type of controls.  I believe the agency is
trying to do what it tries to force the pharmaceutical companies to do
and that is to continue to look at our systems and to continue to
implement better systems.

	If it is to implement better systems, I think, in changing the NDC code
for this contract manufacturer, this contract manufacturer adds
different things for us more to look at and increases the chance of
error.

	If it is a prior-approval supplement and you have shown that it is the
same formulation, it is the same product and it is manufactured in
India, Switzerland and it is the same formulation.  I ask the agency to
consider that it be the same NDC code.

	In terms of recalls, you can still track it by the lot number, which
identifies that lot number being manufactured on such-and-such a date at
such-and-such at time and by what place it was manufactured.  Therefore,
it can be recalled.

	If it is a recall on a formulation, that whole product will be
recalled.  Therefore, it decreases--may decrease--the need to recall, in
terms of having different NDC number codes.

	DR. GARDNER:  So are you suggesting that we carry lot-number
information in listing?

	MS. ROBINSON:  That is not the suggestion, to carry it.  But if the
agency's concern is do you have control.  If you have a recall, can the
FDA know what lot or where that product was made.  You still can
because, by that lot number, A,B,C,X,Y,Z, I can tell you, and I am sure
every pharmaceutical company here or every company can tell you where it
was made, who manufactured it, who packaged it, who handled it, who
analyzed it.  Therefore, you still have the same controls.

	MR. BERNSTEIN:  Thank you very much.

	MS. McGAHAN:  Good morning.  I am Chris McGahan from Abraxis
Pharmaceutical Products, Division of Abraxis Bioscience.  I have a
comment on regards to separate NDC number for each level of packaging.

	The proposed ruling says that there will be a NDC number for the
individual unit, the package and the shipper.  Being a somewhat small
company, we currently have one NDC number that encompasses this.  If we
were to have to go through and do a separate NDC number for each level,
the number of man hours to change all of that labeling would be enormous
for us.

	We sell a package.  We may sell a 2 ml vial packaged in 25 packaged in
50 in a shipper.  We will give it a package code of 2 because that is
its end unit.  For us, this is just an easier way--we can keep track of
it all the way through to our batch records and all of that.  But, to
ask for us to have three levels of NDC numbers for one product is a
massive undertaking.

	MR. LEVIN:  So when you sign that level with No. 2, which was that--

	MS. McGAHAN:  That would be the package code.  That was be for its a 2
ml vial.  It would be a package 2 ml.

	MR. LEVIN:  If you have a number of them in one package, in one box?

	MS. McGAHAN:  It is just packaged as 25.  It is then stated in the PIs
and the SPL as its package size of being 25.

	MR. LEVIN:  That is what, then, you assign a number to that?  The vial
or the whole package?

	MS. McGAHAN:  To the vial only.

	MR. LEVIN:  Then, if you are packaging different iterations--

	MS. McGAHAN:  Then that number will change.  If our main package is--we
pretty much package everything in 25s.  If it changes, say, to a 10 and
we have a 10 and a 25, the 25 will help the package code of 02 being the
vial unit.  The 10 pack will have a 10 because it is now a 10-pack.

	MR. LEVIN:  Okay.  So a package of 25 2 ml vials and the package of 10
will have two different--

	MS. McGAHAN:  Yes.

	MR. LEVIN:  Then the trouble with adding a NDC at each--at the package
and the vial, it is putting it on the package of the product, itself, or
just coming up with the number?

	MS. McGAHAN:  It is not coming up with the number.  It would be a
matter of labeling for each component because currently, if our label,
vial label, is sufficiently--holds all of the information, it will also
be used as the tray label.  It will be placed on the front of the tray.
Then there is a separate diagraphed barcode label that really has just
the lot and XP and a barcode that goes on top of the tray.

	If this were to be implemented, we would have to create a separate tray
label for each of those trays and then another one for the shipper.

	MR. LEVIN:  So it is the labeling on each one of those components, not
so much the number, itself.

	MS. McGAHAN:  No; not the number.

	MR. LEVIN:  The barcode right now, or the numbers on that outside
package.

	MS. McGAHAN:  Yes.

	DR. GARDNER:  You talked about three levels.  So there is the unit
vial, which has its own NDC.  Then you have boxes of 10 or 25 which
would each have their own NDC number.

	MS. McGAHAN:  Currently, no.

	DR. GARDNER:  But then you said three levels.  Then a box, a carton
full of boxes, of 25?

	MS. McGAHAN:  Yes; the shipper.

	DR. GARDNER:  I am not sure we envisioned that third level.  I think we
definitely did envision the second level.

	MS. McGAHAN:  That was just my interpretation of what I read, that it
was the individual, the carton and the shipper level.

	DR. GARDNER:  You need to help us, in your comments, clarify those
issues so we can decide exactly how to do that.

	MS. McGAHAN:  Okay.  Thank you.

	MR. BERNSTEIN:  Thank you.

	MR. NEWMAN:  My name is Rick Newman with RnD Services.  I want to bring
up a topic I haven't heard talked about yet, at least publicly.  Some of
the companies I work with are pharmacy compounders who are not required,
of course, to list as pharmacy compounders.  But what we have found
recently in doing some work in conjunction with FDA, we have put unique
NDC numbers--we have voluntarily gotten an establishment listing
regulation, so we have gotten our NDC numbers.

	They are very unique for that compounded product because they can claim
the diluent and sometimes maybe multiple actives, whatever it might be.
We put the NDC, barcoded it, and given it to the hospitals.  It has
become very useful in the hospital setting from a point-of-care
perspective because then, when they scan the patients wrist I.D., and
scan our drug, they can see that they are getting the right product, the
right compounded pharmacy product into the right patient.

	Now, because it contains multiple products and the rest of it, the way
it is set up, according to the rule, there are a lot of issues.  You can
see around being multiple products and the rest of it.  Now, we are just
trying to figure out how we would comply or could we continue, if we did
as John Gardner suggested, to suggest NDC number with our establishment
listing.  But we, of course, wouldn't have all the various labeling
pieces that you would get with a branded product and the rest of it.

	That is the issue we are trying to face and I was wondering if you guys
had thought about that one yet.

	MR. LEVIN:  Do you currently list those compounded products?

	MR. NEWMAN:  No; we do not list the compounded products.  We have
actually gotten direction from FDA because we have hundreds of them.  We
don't list them.

	MR. LEVIN:  So you just put an NDC number on there but don't list those
products.

	MR. NEWMAN:  And they are not listed; yes.

	MR. LEVIN:  You would be interested in listing them?

	MR. NEWMAN:  Quite honestly, we would just as soon continue not to list
them.  That would make it easier for us and I would think easier for you
because, basically, when a physician calls up and needs a new compound
for that patient, we are talking about moving fairly quickly.  The  time
constraint for that is an issue for us.

	MR. LEVIN:  I may have put it a different way.  You would want to
continue using the NDC.

	MR. NEWMAN:  Correct.  We would not want, for example, for an inspector
to come in and see our NDC numbers and say, oh, they are not listed and
you are misbranded in some way.  That is the concern from the compliance
point of view.

	DR. GARDNER:  These are pharmacy-compounded products that are
patient-specific so they all have the patient's name of them.

	MR. NEWMAN:  Some do.  Some don't.  Some are anticipatory compounding.
You can get to a whole--we can have a whole day on that one.  But that
is not--

	DR. GARDNER:  We don't want to get into that issue.

	MR. NEWMAN:  We don't want to go there.

	DR. GARDNER:  But if you have a patient-specific product that has a
patient's name on it, you would want to use an NDC for that; is that
what your question is?

	MR. NEWMAN:  Yes, because sometimes--just take something like oxytocin
where it is compounded but it is for many--you leave space for a
patient's name but you have got many patients coming in for labor and
delivery in the hospital in any one day.  So you would still have that
specific NDC number for that oxytocin at that concentration in that
diluent--some hospitals like normal saline, et cetera, Ringer's lactate,
whatever it might be.

	But what is good about it, really, the advantage we see is that it does
get you that traceability right to the patient and right back to us so
there is a public-service aspect to it.  It is just how do we fit it
into the rules and the system.

	MR. BERNSTEIN:  Thank you.

	MR. MIRABELL:  I am Dave Mirabell, Director of Regulatory for Hollister
Stier Laboratories.  Hollister Stier is a manufacturer of allergenic
extracts as well as a contract manufacturer of parenteral drugs and
biologics.

	Speaking regarding allergy extract, part of the business today, allergy
extracts, generally speaking, have been exempt from NDC numbers.  In
many cases, about 10 generic numbers have handled the whole product
line.  By the whole product line, I mean that, under allergy or
biologics, we have 650 different source materials under our BLAs.

	That equates, in the product lines of sizes and formulations to well
over 2,000 NDC numbers.  In actual practice, my firm actively extracts
and manufactures about 350 different source materials but that still
relates to well over 1,000 unique NDC numbers.

	That is just for those products that we would deem stock.  The prior
gentleman talked about custom formulations, custom manufactured
products, that we would manufacture for specialists such as allergists
or ENTs.  Those are finite as to the combinations of allergens and
dilutions and package sizes that might be related.

	I have no idea what this industry will do regarding those products.  I
also want to relate that, probably unique to--most, 99 percent, of the
allergy extracts are shipped directly to the specialist.  They do not go
into the normal distribution chains that most here probably relate to.

	So I am just letting you know the complications of this biological
product line and, if we do move forward in trying to meet these rules in
some regard, it will be a difficult adventure for the seven small
business companies that are involved in this practice.

	I also want to relate kind of a different situation.  If you take 350
different allergens for NDC numbers, in one product form, that means one
package insert, or one PPI, in this proposed system will relate.  We
will use the same PPI for those 350.  So each of those NDC numbers we
would file for that one formulation would use the same PPI.  That
relates to about six different PPIs we have in four different product
forms.

	Maybe if I can add one more thing on NDCs regarding diluents for
allergenic extracts.  Maybe I am bit confused about what I heard
regarding different package sizes.  Diluents for allergenic extracts--we
have NDCs, but we relate them by size of the contents of the diluent.
So, at 2.0 ml for a buffered saline with phenole, which is one of the
products, we would have a 2.0, 4.0, 4.5, 9.0, 20, 30 and 50.  We relate
them all to the base product NDC number but under the package size is
how we differentiate those.

	Thank you.

	MR. BERNSTEIN:  Thank you.  Any other comments?  Otherwise, I think we
can break for lunch.  We are hoping to start again at 1:00 p.m. this
afternoon with more speakers.

	[Whereupon, at 11:55 p.m., the proceedings were recessed to be resumed
at 1:00 p.m.]

	A F T E R N O O N   P R O C E E D I N G S

	[1:00 p.m.]

	MR. BERNSTEIN:  Good afternoon everybody.  I think we will try to keep
moving along with the same kind of efficiency that we had this morning
and go right to the afternoon speakers off the schedule agenda.

	Public Speakers

	MR. BERNSTEIN:  The first speaker is Heidi Horn from Perrigo.

	MS. HORN:  Good afternoon.  I'm Heidi Horn.  I have worked in the
Perrigo Regulatory Affairs Department for the last 17 years and have
overseen the management of NDC-number assignment and drug listing for
the last 16 years.  In fact, Perrigo was the first company to propose
and have accepted by FDA a 2658 form that could be completed
electronically.