Repack or repackage has the meaning set forth in Sec.  207.1 of
this chapter.
    Responsible individual(s) means an individual or individuals who
are designated in the Section 804 Importation Program compliance plan.
Such individuals are responsible for ensuring compliance with the
requirements of the Section 804 Importation Program under their
oversight and with the applicable provisions of the Federal Food, Drug,
and Cosmetic Act and this part.
    Section 804 Importation Program (``SIP'') means a program under
section 804 of the Federal Food, Drug, and Cosmetic Act, and this part,
that has been authorized by FDA for the importation of eligible
prescription drugs from Canada.
    Section 804 Importation Program Sponsor (``SIP Sponsor'') means a
State or Indian Tribe that regulates wholesale drug distribution and
the practice of pharmacy that submits a proposal to FDA that describes
a program to facilitate the importation of prescription drugs from
Canada under section 804 of the Federal Food, Drug, and Cosmetic Act
and is responsible for oversight of the implementation of the program.
After an initial 2-year period beginning on the date of the first
import entry under any SIP authorized under this part, the Secretary
may determine, based on experience under the program, that there is a
sufficient likelihood that a proposal that does not include a State or
Indian Tribe as the SIP sponsor could provide the same level of
assurance of safety as a proposal that does include such a sponsor,
such that FDA may begin receiving, reviewing, and potentially
authorizing applications for SIPs without such a sponsor. After the
Secretary makes such a determination, a pharmacist or wholesaler may
propose a SIP that does not include a State or Indian Tribe as a
sponsor, and FDA may authorize such a SIP if the sponsor demonstrates
that the SIP meets the criteria for authorization with the same level
of assurance of safety as a proposal that includes a State or Indian
Tribe as the SIP sponsor, which FDA shall evaluate consistent with any
considerations described in the Secretary's determination, including by
evaluating whether the application demonstrates that the proposed
sponsor has sufficient relevant experience, such as participating in a
SIP and demonstrating compliance with the requirements of the Federal
Food, Drug, and Cosmetic Act and this part.

    Section 804 Importation Program Co-Sponsor (``SIP Co-Sponsor'')
means any other State or Indian Tribe, or a pharmacist or a wholesale
distributor that, with the SIP Sponsor, signs a proposal to FDA that
describes a program to facilitate the importation of prescription drugs
from Canada under section 804 of the Federal Food, Drug, and Cosmetic
Act.
    Section 804 Serial Identifier (``SSI'') means a unique alphanumeric
serial number of up to 20 characters that is assigned and placed on or
affixed by the Foreign Seller to each package and homogenous case of
the product that the Foreign Seller intends to sell to an Importer. For
purposes of the SSI, ``package'' means the smallest individual saleable
unit of product for distribution that is intended by the Foreign Seller
for sale to an Importer located in the United States, and ``individual
saleable unit'' means the smallest container of product sold by the
Foreign Seller to the Importer.
    Serious adverse event means:
    (1) An adverse event is considered ``serious'' if it results in any
of the following outcomes:
    (i) Death;
    (ii) A life-threatening adverse event;
    (iii) Inpatient hospitalization or prolongation of existing
hospitalization;
    (iv) A persistent or significant incapacity or substantial
disruption of the ability to conduct normal life functions; and/or
    (v) A congenital anomaly/birth defect.
    (2) Other events that may be considered serious adverse events:
Important medical events that may not result in one of the listed
outcomes in this definition may be considered serious adverse events
when, based upon appropriate medical judgment, they may jeopardize the
patient or study subject and may require medical or surgical
intervention to prevent one of the outcomes listed in this definition.
Examples include: Allergic bronchospasm requiring intensive treatment
in an emergency department or at home, blood dyscrasias or convulsions
that do not result in inpatient hospitalization, or the development of
product dependency or product abuse.
    Statutory Testing means the testing of an eligible prescription
drug as required by section 804(d)(1)(J) and (L) and section 804(e) of
the Federal Food, Drug, and Cosmetic Act, including for authenticity,
for degradation, and to ensure that the prescription drug is in
compliance with established specifications and standards.
    Suspect foreign product means a drug purchased by a Foreign Seller
from a manufacturer, and intended for sale to an Importer in the United
States, for which the Foreign Seller has reason to believe that such
product:
    (1) Is potentially counterfeit, diverted, or stolen;
    (2) Is potentially intentionally adulterated such that the product
would result in serious adverse health consequences or death to humans;
    (3) Is potentially the subject of a fraudulent transaction; or
    (4) Appears otherwise unfit for distribution such that the product
would result in serious adverse health consequences or death to humans.
    Transaction means the transfer of product between persons in which
a change of ownership occurs, in accordance with section 581(24) of the
Federal Food, Drug, and Cosmetic Act. For the purposes of this part,
``transaction'' includes the sale and transfer of product between the
manufacturer and Foreign Seller. The sale and transfer of product
between Foreign Seller and Importer also constitutes a ``transaction.''
    Unexpected adverse event means an adverse event that is not
included in the current U.S. labeling for the drug product. Events that
may be symptomatically or pathophysiologically related to an adverse
event included in the labeling but differ from the labeled event
because of greater severity or specificity would be considered
unexpected. ``Unexpected,'' as used in this definition, also refers to
adverse events that are mentioned in the product labeling as occurring
with a class of products or anticipated from the pharmacological
properties of the product but are not specifically mentioned as
occurring with the particular product.
    (1) Example of greater severity. Under this definition, hepatic
necrosis would be unexpected if the labeling referred only to elevated
hepatic enzymes or hepatitis.
    (2) Example of greater specificity. Cerebral thromboembolism and
cerebral hemorrhage would be unexpected if the labeling included only
cerebrovascular accidents.
    Unique facility identifier means the identifier required to be
submitted by the registrant for drug establishment registration under
section 510 of the Federal Food, Drug, and Cosmetic Act in accordance
with Sec.  207.25 of this chapter. For Foreign Sellers registering
under section 804 of the Federal Food, Drug, and Cosmetic Act, the term
``unique facility identifier'' means the identifier required to be
submitted under Sec.  251.9 in accordance with the system specified
under section 510 of the Federal Food, Drug, and Cosmetic Act.
    Wholesaler means a person licensed as a wholesale distributor, as
the terms ``licensed'' and ``wholesale distributor'' are defined in
section 581(9)(A) and 581(29), respectively. The term ``wholesaler''
does not include a person authorized to import drugs under section
801(d)(1).

Subpart B--Section 804 Importation Program Proposals and Pre-Import
Requests

Sec.  251.3  SIP proposal submission requirements.

    (a) A SIP Sponsor may delegate implementation activities to a SIP
co-sponsor but the SIP Sponsor remains responsible for oversight of the
implementation of the program.
    (b) A SIP Sponsor must only designate one Foreign Seller and one
Importer per initial proposal. Additional Foreign Sellers and Importers
may be added to an authorized SIP through a supplemental proposal under
Sec.  251.8.
    (c) A SIP Sponsor that intends to implement a SIP under this part
must submit a proposal to FDA in electronic format via FDA's Electronic
Submissions Gateway (ESG) or to an alternative transmission point
identified by FDA. The proposal must include:
    (1) A cover sheet containing the following:
    (i) Name or names of SIP Sponsor and co-sponsors, if any;
    (ii) Name and contact information for a person authorized to serve
as the point of contact with FDA during its review of the proposal; and
    (iii) The signature of the SIP Sponsor and co-sponsors, if any, or
authorized representative who is an employee or agent of the Sponsor or
co-sponsor and has been authorized to sign the proposal for the Sponsor
or co-sponsor. The signatory must reside or have a place of business
within the United States, and the proposal cover sheet must contain the
name, title, and business address of the signatory.
    (2) A table of contents;
    (3) An introductory statement that includes an overview of the SIP
Sponsor's SIP Proposal; and
    (4) The SIP Sponsor's importation plan.
    (d) The overview of the SIP Proposal must include:
    (1) The name of the SIP, if any, and the name or names and address
or addresses of the SIP Sponsor and co-sponsors, if any;
    (2) The name, email address, and telephone number of the
responsible individual(s);

    (3) The name and DIN of each eligible prescription drug that the
SIP Sponsor seeks to include in the SIP;
    (4) The name and address of the applicant that holds the approved
NDA or ANDA for each eligible prescription drug's FDA-approved
counterpart, and the approved NDA or ANDA number;
    (5) The name and address of the manufacturer of the finished dosage
form of the eligible prescription drug, if known or reasonably known;
    (6) The name and address of the manufacturer of the active
ingredient or ingredients of the eligible prescription drugs, if known
or reasonably known;
    (7) The name and address of the Foreign Seller;
    (8) A copy of the Foreign Seller's Health Canada Drug Establishment
License;
    (9) The name and address of the Importer;
    (10) The name and address of the FDA-registered repackager or
relabeler, if different from the Importer, that will relabel the
eligible prescription drugs (including any limited repackaging in
accordance with the requirements in this part), along with adequate
evidence of registration and of satisfactory resolution of any
objectionable conditions or practices identified during its most recent
FDA inspection, if applicable; and
    (11) A summary of how the SIP Sponsor will ensure that:
    (i) The imported eligible prescription drugs meet the Statutory
Testing requirements;
    (ii) The supply chain is secure;
    (iii) The labeling requirements of the Federal Food, Drug, and
Cosmetic Act and this part are met;
    (iv) The post-importation pharmacovigilance and other requirements
of the Federal Food, Drug, and Cosmetic Act and this part are met; and
    (v) The SIP will result in a significant reduction in the cost to
the American consumer of the eligible prescription drugs that the SIP
Sponsor seeks to import.
    (e) The SIP Sponsor's importation plan must:
    (1) Identify the SIP Sponsor, including any co-sponsors, identify
the responsible individual(s), and identify the applicant that holds
the approved NDA or ANDA for each eligible prescription drug's FDA-
approved counterpart, the manufacturer(s) of the finished dosage form
and the active ingredient or ingredients of each eligible prescription
drug that the SIP Sponsor seeks to import, if known or reasonably
known, the Foreign Seller, if known or reasonably known, and the
Importer, and explain the legal relationship, if any, of each of these
entities to the SIP Sponsor.
    (2) Include an attestation and information statement containing a
complete disclosure of any past criminal convictions or violations of
State, Federal, or Canadian laws regarding drugs or devices against or
by the responsible individual(s), Foreign Seller, or Importer or an
attestation that the responsible individual(s), Foreign Seller, or
Importer has not been involved in, or convicted of, any such
violations. Such attestation and information statement must include
principals, any shareholder who owns 10 percent or more of outstanding
stock in any non-publicly held corporation, directors, officers, and
any facility manager or designated representative of such manager.
    (3) Include a list of all disciplinary actions, to include the date
of and parties to any action imposed against the responsible
individual(s), Foreign Seller, or Importer by State, Federal, or
Canadian regulatory bodies, including any such actions against the
principals, owners, directors, officers, quality unit, or any facility
manager or designated representative of such manager for the previous 7
years prior to submission of the SIP Proposal.
    (4) Include:
    (i) The Health Canada inspectional history for the Foreign Seller
for the previous 5 years or, if the Foreign Seller has been licensed
for less than 5 years, for the duration of its period of licensure; and
    (ii) The State and Federal inspectional history for the Importer
for the previous 5 years or, if the Importer has been licensed for less
than 5 years, for the duration of its period of licensure.
    (5) Include the proprietary name (if any), the established name,
the approved application numbers, and the DIN and National Drug Code
(NDC) for each eligible prescription drug that the SIP Sponsor seeks to
import from Canada and for its FDA-approved counterpart. The SIP
Sponsor's importation plan must also include as much of the information
that is required by Sec.  251.5 about the HPFB-approved product and its
FDA-approved counterpart as is available, including the name and
quantity of the active ingredient, the inactive ingredients, and the
dosage form.
    (6) Provide adequate evidence that each HPFB-approved drug's FDA-
approved counterpart drug is currently commercially marketed in the
United States.
    (7) Describe, to the extent possible, the testing that will be done
to establish that the HPFB-approved drug meets the conditions in the
NDA or ANDA for the HPFB-approved drug's FDA-approved counterpart. The
SIP Sponsor's importation plan must also identify the qualifying
laboratory that will conduct the Statutory Testing for the Importer, if
the Importer is responsible for conducting the Statutory Testing, and
it must establish that the laboratory is qualified in accordance with
Sec.  251.15 to conduct the tests.
    (8) Include a copy of the FDA-approved drug labeling for the FDA-
approved counterpart of the eligible prescription drug, a copy of the
proposed labeling that will be used for the eligible prescription drug,
and a side-by-side comparison of the FDA-approved labeling and the
proposed labeling, including the Prescribing Information, carton and
container labeling, and patient labeling (e.g., Medication Guide,
Instructions for Use, patient package inserts), with all differences
annotated and explained. The SIP Proposal must also include a copy of
the HPFB-approved labeling.
    (9) Explain how the SIP Sponsor will ensure that the SIP will
result in a significant reduction in the cost to the American consumer
of the eligible prescription drugs that the SIP Sponsor seeks to
import. The explanation must include any assumptions and uncertainty,
and it must be sufficiently detailed to allow for a meaningful
evaluation.
    (10) Explain how the SIP Sponsor will ensure that all the
participants in the SIP comply with the requirements of section 804 of
the Federal Food, Drug, and Cosmetic Act and this part.
    (11) Describe the procedures the SIP Sponsor will use to ensure
that the requirements of this part are met, including the steps that
will be taken to ensure that the:
    (i) Storage, handling, and distribution practices of supply chain
participants, including transportation providers, meet the requirements
of part 205 of this chapter and do not affect the quality or impinge on
the security of the eligible prescription drugs;
    (ii) Supply chain is secure;
    (iii) Importer screens the eligible prescription drugs it imports
for evidence that they are adulterated, counterfeit, damaged, tampered
with, expired, suspect foreign product, or illegitimate foreign
product; and
    (iv) Importer fulfills its responsibilities to submit adverse
event, field alert, and other reports required by the SIP, the Federal
Food, Drug, and Cosmetic Act, or this part.
    (12) Explain how the SIP Sponsor will educate pharmacists,
healthcare

providers, pharmacy benefit managers, health insurance issuers and
plans, as appropriate, and patients about the eligible prescription
drugs imported under its SIP.
    (13) Include the SIP's recall plan, including an explanation of how
the SIP Sponsor will obtain recall or market withdrawal information and
how it will ensure that recall or market withdrawal information is
shared among the SIP Sponsor, the Foreign Seller, the Importer, and FDA
and provided to the manufacturer.
    (14) Include the SIP's return plan, including an explanation of how
the SIP Sponsor will ensure that product that is returned after
distribution in the United States is properly dispositioned in the
United States, if it is a non-saleable return, in order to protect
patients from expired or unsafe drugs, and an explanation of how the
SIP Sponsor will prevent the non-saleable returned eligible
prescription drugs from being exported from the United States. In the
event that a returned eligible prescription drug may be considered
saleable, include an explanation for how the returned product will be
determined to be saleable and under what circumstances such eligible
prescription drugs may be re-distributed in the United States.
    (15) Include the SIP's compliance plan, which must include:
    (i) A description of the division of responsibilities among co-
sponsors, if any, which includes a plan for timely communication of any
compliance issues to the SIP Sponsor;
    (ii) Identification of responsible individual(s) and a description
of the respective area(s) of the SIP, the Federal Food, Drug, and
Cosmetic Act, or this part that will be under each responsible
individual's oversight;
    (iii) The creation of written compliance policies, procedures, and
protocols;
    (iv) The provision of education and training to ensure that Foreign
Sellers, Importers, qualifying laboratories, and their employees
understand their compliance-related obligations;
    (v) The creation and maintenance of effective lines of
communication, including a process to protect the anonymity of
complainants and to protect whistleblowers; and
    (vi) The adoption of processes and procedures for uncovering and
addressing noncompliance, misconduct, or conflicts of interest.
    (16) Explain how the SIP Sponsor will ensure that any information
that the manufacturer supplies to authenticate a prescription drug
being tested and confirm that the labeling of the prescription drug
complies with labeling requirements under the Federal Food, Drug, and
Cosmetic Act, and any trade secrets or commercial or financial
information that is privileged or confidential that the manufacturer
supplies for the purposes of testing or otherwise complying with the
Federal Food, Drug, and Cosmetic Act and this part, are kept in strict
confidence and used only for the purposes of testing or otherwise
complying with the Federal Food, Drug, and Cosmetic Act and this part.

Sec.  251.4  Review and authorization of importation program proposals.

    Based on a review of a SIP Proposal or supplemental proposal
submitted under this part, FDA may authorize a SIP, modify a SIP, or
extend the authorization period of a SIP, that meets the requirements
of this part. FDA may use a phased review process to review a SIP
Proposal that does not identify a Foreign Seller in an initial
submission, under which FDA may notify the Sponsor of such a SIP
Proposal whether the Sponsor's SIP Proposal otherwise meets the
requirements of this part. In such a case, the required information
regarding importers, relabelers, and repackagers still must be included
in the initial submission of the SIP Proposal, and the SIP Proposal
will be denied if a Foreign Seller is not identified within 6 months of
the initial submission date of the SIP Proposal.
    (a) FDA may deny a request for authorization, modification, or
extension of a SIP, including if a SIP Proposal or supplemental
proposal does not meet the requirements of this part. When a SIP
Proposal or supplemental proposal meets the requirements of this part,
FDA may nonetheless decide not to authorize the SIP Proposal or
supplemental proposal. For example, FDA may decide not to authorize a
SIP Proposal or supplemental proposal because of potential safety
concerns with the SIP; because a Foreign Seller is not identified
within 6 months of the initial submission of the SIP Proposal; because
of the degree of uncertainty that the SIP Proposal or supplemental
proposal would adequately ensure the protection of public health;
because of, based on the recommendation of another Department of Health
and Human Services (HHS) component as directed by the Secretary, the
relative likelihood that the SIP Proposal or supplemental proposal
would not result in significant cost savings to the American consumer;
because of the potential for conflicts of interest; or in order to
limit the number of authorized SIPs so FDA can effectively and
efficiently carry out its responsibilities under section 804 of the
Federal Food, Drug, and Cosmetic Act in light of the amount of
resources allocated to carrying out such responsibilities.
    (b) FDA will notify a SIP Sponsor in writing when FDA receives the
SIP Sponsor's SIP Proposal or supplemental proposal.
    (c) FDA will make a reasonable effort to promptly communicate to a
SIP Sponsor about any information required by Sec.  251.3 that was not
submitted in a SIP Proposal.
    (1) FDA may notify a SIP Sponsor if FDA believes additional
information would help FDA's review of a SIP Proposal or supplemental
proposal.
    (2) FDA will notify a SIP Sponsor in writing whether FDA has
decided to authorize or not to authorize the SIP Sponsor's SIP Proposal
or supplemental proposal.

Sec.  251.5  Pre-Import Request.

    (a) An eligible prescription drug may not be imported or offered
for import under this part unless the Importer has filed a Pre-Import
Request for that drug in accordance with this section and FDA has
granted the Pre-Import Request.
    (b) The Importer must submit a complete Pre-Import Request in
electronic format via the ESG, or to an alternative transmission point
identified by FDA, at least 30 calendar days prior to the scheduled
date of arrival or entry for consumption, whichever occurs first, of an
eligible prescription drug covered under an authorized SIP.
    (c) A complete Pre-Import Request must include, at a minimum:
    (1) Identification of the Importer, including Importer name;
business type (wholesale distributor or pharmacist); U.S. license
number(s) and State(s) of license; business address; unique facility
identifier if required to register with FDA as an establishment under
section 510 of the Federal Food, Drug, and Cosmetic Act or FDA
establishment identification number if not required to register under
section 510 of the Federal Food, Drug, and Cosmetic Act; and the name,
email address, and phone number of a contact person.
    (2) Identification of the FDA-authorized SIP, including the name of
the SIP, if any; the name or names of the SIP Sponsor and co-sponsors,
if any; business address; and the name, email address, and phone number
of a contact person.
    (3) Identification of the Foreign Seller, including the name of the
Foreign Seller; business address; unique facility identifier; any
license numbers issued by Health Canada or a provincial

regulatory body; and the name, email address, and phone number of a
contact person.
    (4) Identification and description of each drug covered by the Pre-
Import Request, including, for each drug, the following information:
    (i) Established and proprietary name of the HPFB-approved drug, as
applicable; DIN; and complete product description, including strength,
description of dosage form, and route(s) of administration.
    (ii) Active pharmaceutical ingredient (API) information, including:
    (A) Name of API;
    (B) Manufacturer of API and its unique facility identifier; and
    (C) Amount of API and unit measure in the eligible prescription
drug;
    (iii) Established name and proprietary name, as applicable, of the
FDA-approved counterpart drug and NDA or ANDA number.
    (iv) Manufacturer of the eligible prescription drug with the
business address and unique facility identifier.
    (v) Copies of the invoice and any other documents related to the
manufacturer's sale of the drug to the Foreign Seller that was provided
by the manufacturer to the Importer, and copies of the same documents
provided by the Foreign Seller to the Importer.
    (vi) Quantity, listed separately by dosage form, strength, batch
and lot or control number assigned by the manufacturer to the eligible
prescription drug intended to be imported under this Pre-Import
Request, compared to the quantity of each batch and lot or control
number originally received by the Foreign Seller from the manufacturer,
and the date of such receipt.
    (vii) Expiration date of the HFPB-approved drug, listed by lot or
control number assigned by the manufacturer.
    (viii) Expiration date to be assigned to the eligible prescription
drug when relabeled by the Importer with a complete description of how
that expiration date was determined using the manufacturer's stability
studies in accordance with the FDA-approved NDA or ANDA.
    (ix) NDC proposed for assignment by the Importer.
    (x) FDA product code for the eligible prescription drug(s) to be
imported.
    (xi) Unless the manufacturer has notified the Importer that it
intends to conduct the required testing as provided in Sec.  251.16(e),
a Statutory Testing plan that includes:
    (A) A description of how the samples will be selected from a
shipment for the Statutory Testing;
    (B) The name and location of the qualifying laboratory in the
United States that will conduct the Statutory Testing; and
    (C) A description of the testing method(s) that will be used to
conduct the Statutory Testing.
    (xii) Attestation and information statement from the manufacturer
that establishes that the drug proposed for import, but for the fact
that it bears the HPFB-approved labeling, meets the conditions in the
FDA-approved NDA or ANDA, including any process-related or other
requirements for which compliance cannot be established through
laboratory testing. Accordingly, the attestation and information
statement must include, at a minimum:
    (A) Confirmation that the HPFB-approved drug has the active
ingredient(s), active ingredient source(s) (including manufacturing
facility or facilities), inactive ingredient(s), dosage form,
strength(s), and route(s) of administration described in the FDA-
approved drug's NDA or ANDA.
    (B) Confirmation that the HPFB-approved drug conforms to the
specifications in the FDA-approved drug's NDA or ANDA regarding the
quality of the drug substance(s), drug product, intermediates, raw
materials, reagents, components, in-process materials, container
closure systems, and other materials used in the production of the
drug.
    (C) Confirmation that the HPFB-approved drug was manufactured in
accordance with the conditions described in the FDA-approved drug's NDA
or ANDA, including with regard to the facilities and manufacturing
lines that are used, and in compliance with current good manufacturing
practice requirements set forth in section 501 of the Federal Food,
Drug, and Cosmetic Act and parts 4 (if a combination product), 210, and
211 of this chapter.
    (D) Original date of manufacture or the date used to calculate the
labeled expiration date based on the HPFB-approved or scientifically
validated expiration period, the expiration period set forth in the
FDA-approved drug's NDA or ANDA, and any other information needed to
label the drug with an expiration date within the expiration dating
period determined by stability studies in the FDA-approved NDA or ANDA.
    (E) Information needed to confirm that the labeling of the
prescription drug complies with labeling requirements under the Federal
Food, Drug, and Cosmetic Act.
    (xiii) Information related to the importation, including:
    (A) Location of the eligible prescription drugs in Canada and
anticipated date of shipment (date the eligible prescription drug(s)
leave their location in Canada);
    (B) Name, address, email address, and telephone number of the
Foreign Seller;
    (C) Anticipated date of export from Canada and Canadian port of
exportation;
    (D) Anticipated date and approximate time of arrival at the port
authorized by FDA to import eligible prescription drugs under section
804 of the Federal Food, Drug, and Cosmetic Act;
    (E) The name, address, unique facility identifier or FDA
establishment identification number, and telephone number of the
secured warehouse, location within a specific foreign trade zone, or
other secure distribution facility controlled by or under contract with
the Importer where the eligible prescription drug will be stored
pending testing, relabeling, and FDA determination of admissibility;
    (F) Information regarding the facility where the relabeling and any
repackaging allowed under the authorized SIP will occur for the
eligible prescription drug, including:
    (1) The facility's unique facility identifier;
    (2) The facility's name, address, and FDA establishment identifier
number;
    (3) The anticipated date the relabeling and any limited repackaging
will be completed; and
    (4) Information about where the relabeled drug will be stored
pending distribution, including the FDA establishment identification
number of the storage facility, if available.
    (d) The manufacturer must provide the attestation and information
statement described in paragraph (c)(4)(xii) of this section to the
Importer within 30 calendar days of receiving the Importer's request.
If the manufacturer cannot provide the attestation and information
statement, it must notify FDA and the Importer of its inability to
provide the attestation and information statement and articulate with
specificity the reason(s) why it cannot provide the attestation and
information statement.
    (e)(1) The Importer must provide the executed batch record,
including the certificate of analysis, for at least one recently
manufactured, commercial-scale batch of the HPFB-approved drug, and at
least one recently manufactured, commercial-scale batch of the FDA-
approved drug that was produced for and released for distribution to
the U.S. market under an NDA or ANDA.
    (2) The manufacturer must provide these records to the Importer,
within 30 calendar days of receiving the Importer's request, for each
manufacturing line that the

manufacturer used to produce either or both of the drugs.

Sec.  251.6  Termination of authorized importation programs.

    (a) Unless an extension is granted under this part, authorization
for a SIP automatically terminates after 2 years, or a shorter period
of time if a shorter period of time is specified in the authorization
for the SIP.
    (b) The authorization period for a SIP begins when the Importer, or
its authorized customs broker, files an electronic import entry for
consumption for its first shipment of drugs under the SIP.
    (c) Notwithstanding paragraph (a) of this section, authorization
for a SIP terminates if the Importer, or its authorized customs broker,
does not file an electronic import entry for consumption for a shipment
of eligible prescription drugs under the SIP within 1 year of the date
that the SIP was authorized.
    (d) FDA will terminate authorization of a SIP upon request from the
SIP Sponsor.
    (e) An eligible prescription drug cannot be shipped into the United
States under this part, and is subject to refusal of admission into the
United States, if the authorization of the SIP has terminated.

Sec.  251.7  Suspension and revocation of authorized importation
programs.

    (a) FDA may suspend a SIP under any of the circumstances set forth
in Sec.  251.18, or under any other circumstances in FDA's discretion.
An eligible prescription drug cannot be shipped into the United States
under this part, and is subject to refusal of admission into the United
States, if FDA has suspended the SIP or revoked its authorization.
    (b) SIP Sponsors and other SIP participants must agree to submit to
audits of their books and records and inspections of their facilities
as a condition of participation in a SIP. If a SIP Sponsor,
manufacturer, Foreign Seller, Importer, qualifying laboratory, or other
participant in the supply chain delays, denies, or limits an
inspection, or refuses to permit entry, inspection, or audit of its
facility or its records, FDA may suspend the SIP, in whole or in part,
immediately.
    (c) FDA may revoke authorization of a SIP, in whole or in part,
including with respect to one or more drugs in the SIP, at any time if
FDA determines that:
    (1) The SIP Proposal contained an untrue statement of material
fact;
    (2) The SIP Proposal omitted material information;
    (3) The SIP no longer meets the requirements of section 804 of the
Federal Food, Drug, and Cosmetic Act, this part, or the SIP, including,
among other things, if FDA finds that the manufacturer, the Foreign
Seller, the Importer, or any other supply chain participant is found to
be not compliant with section 501(a)(2)(A) or (B) of the Federal Food,
Drug, and Cosmetic Act;
    (4) Continued implementation of the SIP is reasonably likely to
pose additional risk to the public's health and safety;
    (5) Confidential manufacturer information was disclosed in
violation of Sec.  251.16;
    (6) Continued implementation of the SIP is not reasonably likely to
result in a significant reduction in the cost of the drugs covered by
the SIP to the American consumer;
    (7) Continued monitoring of the SIP imposes too much of a burden on
FDA or HHS resources for carrying out this part or is inconsistent with
FDA or HHS prioritization of resources;
    (8) Continued implementation of the SIP is otherwise inappropriate;
or
    (9) Grounds exist for suspension under paragraph (a) or (b) of this
section and FDA determines it should revoke, either instead of, or
after, suspension.

Sec.  251.8  Modification or extension of authorized importation
programs.

    (a) A supplemental proposal to modify or extend an authorized SIP
must be submitted in electronic format via the ESG, or to an
alternative transmission point identified by FDA, for FDA's
consideration.
    (b) FDA's review and authorization of a supplemental proposal to
modify or extend an authorized SIP is governed by this part. In
reviewing a supplemental proposal, FDA may take into account
information learned subsequent to authorization of the SIP.
    (c) FDA may authorize a supplemental proposal from a SIP Sponsor to
add additional Foreign Sellers or additional Importers to an authorized
SIP if FDA determines the SIP Sponsor has adequately demonstrated that
the SIP has consistently imported eligible prescription drugs in
accordance with section 804 of the Federal Food, Drug, and Cosmetic Act
and this part. Each supply chain under a SIP must be limited to one
manufacturer, one Foreign Seller, and one Importer.
    (d) If FDA authorizes changes to a SIP, the Importer must submit a
new Pre-Import Request in accordance with Sec.  251.5.
    (e) A SIP Sponsor must not make any changes or permit any changes
to be made to a SIP without first securing FDA's authorization.
    (f) A SIP Sponsor may request that FDA extend the authorization
period of an authorized SIP. Such a request must be submitted at least
90 calendar days before the SIP's authorization period will expire. To
be eligible for an extension of the authorized SIP, a SIP must be up to
date on all of the information and records-related requirements of
section 804 of the Federal Food, Drug, and Cosmetic Act and this part.
FDA may extend the authorization period for up to 2 years at a time.

Subpart C--Certain Requirements for Section 804 Importation
Programs

Sec.  251.9  Registration of Foreign Sellers.

    (a) Any Foreign Seller(s) designated in a SIP Proposal must be
registered with FDA before FDA will authorize the SIP Proposal.
    (b) To register, a Foreign Seller must provide the following
information:
    (1) Name of the owner or operator; if a partnership, the name of
each partner; if a corporation, the name of each corporate officer and
director, and the place of incorporation;
    (2) All names of the Foreign Seller, including names under which
the Foreign Seller conducts business or names by which the Foreign
Seller is known;
    (3) Physical address and telephone number(s) of the Foreign Seller;
    (4) Registration number, if previously assigned by FDA;
    (5) A unique facility identifier in accordance with the system
specified under section 510 of the Federal Food, Drug, and Cosmetic
Act;
    (6) All types of operations performed by the Foreign Seller;
    (7) Name, mailing address, telephone number, and email address of
the official contact for the establishment; and
    (8) Name, mailing address, telephone number, and email address of:
    (i) The U.S. agent;
    (ii) The Importer to which the Foreign Seller plans to sell
eligible prescription drugs; and
    (iii) Each SIP Sponsor with which the Foreign Seller works.

Sec.  251.10  Reviewing and updating registration information for
Foreign Sellers.

    (a) Expedited updates. A Foreign Seller must update its
registration information no later than 30 calendar days after:
    (1) Closing or being sold;
    (2) Changing its name or physical address; or

    (3) Changing the name, mailing address, telephone number, or email
address of the official contact or the U.S. agent. A Foreign Seller,
official contact, or U.S. agent may notify FDA about a change of
information for the designated official contact or U.S. agent, but only
a Foreign Seller is permitted to designate a new official contact or
U.S. agent.
    (b) Annual review and update of registration information. A Foreign
Seller must review and update all registration information required
under Sec.  251.9.
    (1) The first review and update must occur during the period
beginning on October 1 and ending December 31 of the year of initial
registration, if the initial registration occurs prior to October 1.
Subsequent reviews and updates must occur annually, during the period
beginning on October 1 and ending December 31 of each calendar year.
    (2) The updates must reflect new changes not previously required to
be reported, along with a summary of the registration updates that were
provided to FDA as required during the calendar year.
    (3) If no changes have occurred since the last registration, a
Foreign Seller must certify that no changes have occurred.

Sec.  251.11  Official contact and U.S. agent for Foreign Sellers.

    (a) Official contact. A Foreign Seller subject to the registration
requirements of this part must designate an official contact. The
official contact is responsible for:
    (1) Ensuring the accuracy of registration information as required
by Sec.  251.9; and
    (2) Reviewing, disseminating, routing, and responding to all
communications from FDA, including emergency communications.
    (b) U.S. agent. (1) A Foreign Seller must designate a single U.S.
agent. The U.S. agent must reside or maintain a place of business in
the United States and may not be a mailbox, answering machine or
service, or other place where a person acting as the U.S. agent is not
physically present. The U.S. agent is responsible for:
    (i) Reviewing, disseminating, routing, and responding to all
communications from FDA, including emergency communications;
    (ii) Responding to questions concerning those drugs that are
imported or offered for import to the United States; and
    (iii) Assisting FDA in scheduling inspections.
    (2) FDA may provide certain information and/or documents to the
U.S. agent. The provision of information and/or documents by FDA to the
U.S. agent is equivalent to providing the same information and/or
documents to the Foreign Seller.

Sec.  251.12  Importer responsibilities.

    (a) The Importer is responsible for:
    (1) In accordance with the procedures set forth in Sec.  207.33 of
this chapter, proposing an NDC for assignment for each eligible
prescription drug imported pursuant to this part;
    (2) Examining the Canadian labeling of a sample of each shipment of
eligible prescription drugs to verify that the labeling is that of the
HPFB-approved drug, and attesting that such examination has been
conducted through reports to FDA required under this part;
    (3) Screening eligible prescription drugs for evidence that they
are adulterated, counterfeit, damaged, tampered with, expired, suspect
foreign product, or illegitimate foreign product;
    (4) Ensuring the eligible prescription drug is relabeled with the
required U.S. labeling, including the container and carton labeling;
Prescribing Information; and patient labeling, such as Medication
Guides, Instruction for Use documents, and patient package inserts, in
accordance with Sec. Sec.  251.13 and 251.14(d);
    (5) Arranging for an entry to be submitted in accordance with Sec.
251.17;
    (6) Collecting and submitting the information and documentation to
FDA about the imported drug(s) pursuant to section 804(d) of the
Federal Food, Drug, and Cosmetic Act, in addition to information about
the Foreign Seller, as set forth in Sec.  251.19; and
    (7) Submitting the adverse event, field alert, and other reports,
and complying with drug recalls, in accordance with Sec.  251.18.
    (b) If the Importer is also relabeling the eligible prescription
drug, the Importer must also:
    (1) Register with FDA as a repackager or relabeler under section
510(b) of the Federal Food, Drug, and Cosmetic Act, in accordance with
Sec.  207.25 of this chapter;
    (2) Obtain a labeler code from FDA and propose an NDC for each
eligible prescription drug pursuant to Sec.  207.33 of this chapter;
and
    (3) List each eligible prescription drug pursuant to Sec.  207.53
of this chapter.
    (c) If the Importer is not itself relabeling the eligible
prescription drug, the Importer must:
    (1) Obtain its own labeler code from FDA under Sec.  207.33(c) of
this chapter;
    (2) Ensure that the eligible prescription drug incorporates the NDC
the Importer proposed for assignment, which must include the Importer's
labeler code; and
    (3) Ensure that the entity relabeling an eligible prescription drug
on its behalf proposes an NDC pursuant to Sec.  207.33 of this chapter
and lists each eligible prescription drug pursuant to Sec.  207.53 of
this chapter.

Sec.  251.13   Labeling of eligible prescription drugs.

    (a) Upon the request of a SIP Sponsor or Importer, the manufacturer
of an eligible prescription drug must provide an Importer written
authorization for the Importer to use, at no cost, the FDA-approved
labeling for the drug. If the manufacturer fails to do so within 30
calendar days of receiving the Importer's request, FDA may deem this
authorization to have been given.
    (b) In addition to the exemption provided in subpart D of part 201
of this chapter, an eligible prescription drug imported for purposes of
this part is exempt from section 502(f)(1) of the Federal Food, Drug,
and Cosmetic Act if all the following conditions are met:
    (1) The Importer or the manufacturer certifies that the drug meets
all labeling requirements under the Federal Food, Drug, and Cosmetic
Act, including the requirements of this part. The Importer of an
eligible prescription drug must either:
    (i) Propose an NDC for the drug following the procedures in Sec.
207.33 of this chapter and list the drug following the procedures in
Sec.  207.53 of this chapter; or
    (ii) Take responsibility to ensure that the entity performing
relabeling on its behalf lists each eligible prescription drug and
incorporates the NDC the Importer proposed for assignment in accordance
with the applicable requirements of part 207 of this chapter.
    (2) The drug must be:
    (i) In the possession of a person (or his or her agents or
employees), including Foreign Sellers and Importers, regularly and
lawfully engaged in the manufacture, transportation, storage, or
wholesale distribution of prescription drugs;
    (ii) In the possession of a retail, hospital, or clinic pharmacy,
or a public health agency, regularly and lawfully engaged in dispensing
prescription drugs; or
    (iii) In the possession of a practitioner licensed by law to
administer or prescribe such drugs.
    (3) The drug is to be dispensed in accordance with section 503(b)
of the Federal Food, Drug, and Cosmetic Act.

    (4) At the time the drug is sold or dispensed, the labeling of the
drug must be the same as the FDA-approved labeling under the applicable
NDA or ANDA, except that the labeling must bear conspicuously:
    (i) The Importer's NDC for the eligible prescription drug, and such
NDC must replace any other NDC otherwise appearing on the label of the
FDA-approved drug;
    (ii) The lot number assigned by the manufacturer of the eligible
prescription drug, on the carton labeling and on the container label;
    (iii) The name and place of business of the Importer;
    (iv) The statement: ``[This drug was/These drugs were] imported
from Canada without the authorization of [Name of Applicant] under the
[Name of SIP Sponsor] Section 804 Importation Program.'' If the SIP
maintains a website, the statement could also include the website
address. This statement must appear in the HOW SUPPLIED/STORAGE AND
HANDLING section for products subject to Sec. Sec.  201.56(d) and
201.57 of this chapter, or in the HOW SUPPLIED section for products
subject to Sec. Sec.  201.56(e) and 201.80 of this chapter. The
statement also must be included on the immediate container label and
outside package;
    (v) For products subject to Sec. Sec.  201.56(d) and
201.57(c)(17)(iii) of this chapter, the NDC(s) assigned to the eligible
prescription drug in accordance with the procedures in Sec.  207.33 of
this chapter must be included in the HOW SUPPLIED/STORAGE AND HANDLING
section in place of the NDC(s) assigned to the FDA-approved versions of
the drug. The NDC(s) also must be included on the immediate container
label and outside package;
    (vi) For products subject to Sec. Sec.  201.56(d) and
201.57(a)(11)(ii) of this chapter, the Adverse Reaction Contact
Reporting Statement under the Adverse Reactions heading in the
Highlights of Prescribing Information. This statement must include the
Importer's name and the telephone number of the firm to provide a
structured process for reporting suspected adverse events; and
    (vii) For products subject to Sec. Sec.  201.56(e) and 201.80(k)(3)
of this chapter, the NDC(s) assigned to the eligible prescription drug
in accordance with the procedures in Sec.  207.33 of this chapter. The
NDC(s) must be included in the HOW SUPPLIED section in place of the
NDC(s) assigned to the FDA-approved versions of the drug. The NDC(s)
also must be included on the immediate container label and outside
package.
    (c) The Importer is responsible for relabeling the drug, or
arranging for it to be relabeled, to meet the requirements of this
part. The relabeling and associated limited repackaging activities must
meet applicable requirements, including applicable current good
manufacturing practice requirements under parts 210 and 211 of this
chapter. Except for repackaging that is necessary to perform the
relabeling described in this part, further repackaging of drugs
imported pursuant to a SIP is prohibited. Repackaging the container
closure of a drug is not permitted under this part.
    (d) The Importer may submit to FDA, in electronic format via the
ESG or to an alternative transmission point identified by FDA, under
Sec.  251.8, a supplemental proposal to modify the labeling of an
eligible prescription drug, for example if the eligible prescription
drug's container is too small to fit the additional information
required by this section.

Sec.  251.14  Supply chain security requirements for eligible
prescription drugs.

    (a) SIP Sponsor. A sponsor of an authorized SIP must ensure that:
    (1) Each drug imported under the SIP is HPFB-approved and labeled
for sale in Canada by the manufacturer before it reaches the Foreign
Seller;
    (2) For each drug that is imported under the SIP and that is
manufactured outside Canada, the drug was authorized for import into
Canada by the manufacturer and was not transshipped through Canada for
sale in another country;
    (3) For each drug imported under the SIP, the drug was sold by the
manufacturer directly to a Foreign Seller;
    (4) For each drug imported under the SIP, the Foreign Seller ships
the drug directly to the Importer in the United States;
    (5) For each drug imported under the SIP, the Foreign Seller
identified in the SIP meets applicable supply chain security
requirements of this part;
    (6) The Importer identified in the SIP meets the applicable
requirements of this part and in sections 582(c) and (d) of the Federal
Food, Drug, and Cosmetic Act; and
    (7) Returned eligible prescription drugs are properly dispositioned
in, and not exported from, the United States.
    (b) Manufacturer. For each transaction of the eligible prescription
drug, the manufacturer must provide to the Importer, within 30 calendar
days of receiving the Importer's request, a copy of all transaction
documents that were provided from the manufacturer to the Foreign
Seller.
    (c) Foreign Seller. (1) A Foreign Seller must have systems in place
to:
    (i) Determine whether a drug in its possession or control that it
intends to sell to the Importer under a SIP is a suspect foreign
product. Upon making a determination that a drug in its possession or
control is a suspect foreign product, or upon receiving a request for
verification from FDA that the Foreign Seller has determined that a
product within its possession or control is a suspect foreign product,
a Foreign Seller must:
    (A) Quarantine such product within its possession or control until
such product is cleared or dispositioned;
    (B) Promptly conduct an investigation, in coordination with the
Importer and the manufacturer, as applicable, to determine whether the
product is an illegitimate foreign product, and verify the product at
the package level, including the SSI; and
    (C) If the Foreign Seller makes the determination that a suspect
foreign product is not an illegitimate foreign product, promptly notify
FDA of such determination for those products that FDA has requested
verification.
    (ii) Determine whether a drug in its possession or control that it
intends to sell to the Importer under a SIP is an illegitimate foreign
product. Upon making a determination that a drug in its possession or
control is an illegitimate foreign product, the Foreign Seller must:
    (A) Quarantine such product within the possession or control of the
Foreign Seller from product intended for distribution until such
product is dispositioned;
    (B) Disposition the illegitimate foreign product within the
possession or control of the Foreign Seller;
    (C) Take reasonable and appropriate steps to assist a manufacturer
or Importer to disposition an illegitimate product not in the
possession or control of the Foreign Seller; and
    (D) Retain a sample of the product for further physical examination
or laboratory analysis of the product by the manufacturer or FDA (or
other appropriate Federal or State official) upon request by FDA (or
other appropriate Federal or State official), as necessary and
appropriate.
    (2)(i) Upon determining that a product in the possession or control
of the Foreign Seller is an illegitimate foreign product, the Foreign
Seller must notify FDA and the Importer that the Foreign Seller
received such illegitimate product not later than 24 hours after making
such determination.

    (ii) Upon the receipt of a notification from the manufacturer, FDA,
the Importer or other wholesale distributor, or dispenser that a
determination has been made that a product that had been sold by the
Foreign Seller is an illegitimate foreign product, a Foreign Seller
must identify all illegitimate foreign product subject to such
notification that is in the possession or control of the Foreign
Seller, including any product that is subsequently received, and
perform the activities to investigate the product described in
paragraph (c)(1) of this section.
    (iii) Upon making a determination, in consultation with FDA, that a
notification is no longer necessary, a Foreign Seller must promptly
notify the Importer and person who sent the notification that the
notification is terminated.
    (iv) A Foreign Seller must keep records of the disposition of an
illegitimate foreign product for not less than 6 years after the
conclusion of the disposition.
    (3) Upon request by FDA, or other appropriate Federal or State
official, in the event of a recall or for purposes of investigating a
suspect foreign product or an illegitimate foreign product, a Foreign
Seller must promptly provide the official with information about its
transactions with the manufacturer and the Importer.
    (4) A Foreign Seller, upon receiving a shipment of eligible
prescription drugs from the manufacturer, must:
    (i) Separate the portion of drugs intended for sale to the Importer
located in the United States, and store such portion separately from
that portion of product intended for sale in the Canadian market;
    (ii) Assign an SSI to each package and homogenous case intended for
sale to the Importer in the United States, unless each such package and
homogenous case displayed a manufacturer-affixed or imprinted product
identifier, as such term is defined in section 581(14) of the Federal
Food, Drug, and Cosmetic Act, at the time of receipt by the Foreign
Seller;
    (iii) Affix or imprint the SSI on each package and homogenous case
intended for sale to the Importer in the United States. Such SSI must
be located on blank space on the package or homogenous case and must
not obscure any labeling for the Canadian market, including the DIN;
and
    (iv) Keep records associating the SSI with the DIN and all the
records the Foreign Seller received from the manufacturer upon receipt
of the original shipment intended for the Canadian market for not less
than 6 years.
    (5) Upon receiving a request for verification from the Importer or
other authorized repackager, wholesale distributor, or dispenser that
is in possession or control of a product such person believes to be
distributed by such Foreign Seller, a Foreign Seller must, not later
than 24 hours after receiving the request for verification, or in such
other reasonable time as determined by the FDA based on the
circumstances of the request, notify the person making the request
whether the SSI that is the subject of the request corresponds to the
SSI affixed or imprinted by the Foreign Seller. If a Foreign Seller
responding to a request for verification identifies an SSI that does
not correspond to that SSI affixed or imprinted by the Foreign Seller,
the Foreign Seller must treat such product as suspect foreign product
and conduct an investigation as described in paragraph (c)(1) of this
section. If the Foreign Seller determines the product is an
illegitimate foreign product, the Foreign Seller must advise the person
making the request of such determination at the time such Foreign
Seller responds to the request for verification.
    (6) For each transaction between the Foreign Seller and the
Importer for an eligible prescription drug, the Foreign Seller must
provide:
    (i) A statement that the Foreign Seller purchased the product
directly from the manufacturer;
    (ii) The proprietary name (if any) and the established name of the
product;
    (iii) The strength and dosage form of the product;
    (iv) The container size;
    (v) The number of containers;
    (vi) The lot number of the product assigned by the manufacturer;
    (vii) The date of the transaction;
    (viii) The date of the shipment, if more than 24 hours after the
date of the transaction;
    (ix) The business name and address of the person associated with
the Foreign Seller from whom ownership is being transferred;
    (x) The business name and address of the person associated with the
Importer to whom ownership is being transferred;
    (xi) The SSI for each package and homogenous case of product; and
    (xii) The Canadian DIN for each product transferred.
    (7) Upon a request by FDA, or other appropriate Federal or State
official, in the event of a recall or for purposes of investigating a
suspect foreign product or an illegitimate foreign product, the Foreign
Seller must promptly provide the official with information about its
transactions with the manufacturer and the Importer.
    (d) Importers. (1) An Importer of an eligible prescription drug
must purchase the drug directly from a Foreign Seller in Canada.
    (2) Upon receipt of an eligible prescription drug in a transaction
from the Foreign Seller, an Importer must facilitate the affixation or
imprinting of a product identifier, as defined in section 581(14) of
the Federal Food, Drug, and Cosmetic Act, for all eligible prescription
drugs. The Importer must ensure that such affixation or imprinting
occurs at the same time the product is relabeled with the required
U.S.-approved labeling for the drug product and, except for repackaging
necessary to perform the relabeling described in this part, cannot
otherwise relabel or repackage the product. The Importer may affix or
imprint the product identifier, or the Importer may contract with an
entity registered with FDA under part 207 of this chapter to accomplish
such relabeling, provided that the entity does not otherwise relabel or
repackage the product, except for repackaging that is necessary to
perform the relabeling described in this part. Any entity with which
the Importer contracts to accomplish such labeling must, even if not
engaged in a repackaging operation with respect to the eligible
prescription drug, have systems and processes in place to meet
applicable requirements of a ``repackager'' under section 582(e) of the
Federal Food, Drug, and Cosmetic Act for any transaction involving the
eligible prescription drug.
    (3) The repackager that affixes or imprints the product identifier
on each package and homogenous case of an eligible prescription drug in
accordance with section 582 of the Federal Food, Drug, and Cosmetic
Act, which may be the Importer or the Importer's authorized
repackager--
    (i) May affix or imprint a product identifier only on a package of
an eligible prescription drug that has a serial number that was
assigned and affixed by the Foreign Seller;
    (ii) Must maintain the product identifier information for such drug
for not less than 6 years; and
    (iii) Must maintain records for not less than 6 years that
associate the product identifier the repackager affixes or imprints
with the serial number assigned by the Foreign Seller and the Canadian
DIN.
    (4) An Importer must retain records, for not less than 6 years,
that allow the Importer to associate the product identifier affixed or
imprinted on each

package or homogenous case of product it received from the Foreign
Seller, with the SSI that had been assigned by the Foreign Seller, and
the Canadian DIN that was on the package when the Foreign Seller
received the product from the manufacturer.
    (5) An Importer must, upon receipt of an eligible prescription drug
and records from a Foreign Seller, compare such information with
information the Importer received from the manufacturer, including
relevant documentation about the transaction that the manufacturer
provided to the Foreign Seller upon its transfer of ownership of the
product for the Canadian market.
    (6) An Importer must comply with all applicable requirements of
section 582 of the Federal Food, Drug, and Cosmetic Act, including
requirements that apply to subsequent transactions with trading
partners, unless a waiver, exception, or exemption applies.
    (7) For transactions of eligible prescription drugs between
Importers and Foreign Sellers under a SIP, an Importer is exempt from
the following specific supply chain security requirements that are
otherwise applicable:
    (i) An Importer is exempt from the prohibition on receiving a
product for which the previous owner did not provide the transaction
history, transaction information, and transaction statement, under
sections 582(c)(1)(A) or (d)(1)(A) of the Federal Food, Drug, and
Cosmetic Act, as applicable, provided that the Importer receives from
the Foreign Seller the information required under paragraph (c) of this
section.
    (ii) An Importer is exempt from the prohibition on receiving a
product that is not encoded with a product identifier, under sections
582(c)(2) or (d)(2) of the Federal Food, Drug, and Cosmetic Act, as
applicable, provided that the product the Importer received from the
Foreign Seller has an SSI.
    (iii) An Importer is exempt from the prohibition on conducting a
transaction with an entity that is not an ``authorized trading
partner,'' under sections 582(c)(3) or (d)(3) of the Federal Food,
Drug, and Cosmetic Act, as applicable.
    (iv) An Importer is exempt from the requirement to verify that a
product in the Importer's possession or control contains a
``standardized numerical identifier'' at the package level, under
sections 582(c)(4)(A)(i)(II) or (d)(4)(A)(ii)(II) of the Federal Food,
Drug, and Cosmetic Act as applicable, provided that the Importer
verifies that each package and homogenous case of the product includes
the SSI affixed or imprinted by the Foreign Seller.

Sec.  251.15  Qualifying laboratory requirements.

    (a) To be considered a qualifying laboratory for purposes of
section 804 of the Federal Food, Drug, and Cosmetic Act and this part,
a laboratory must have ISO 17025 accreditation.
    (b) To be considered a qualifying laboratory for purposes of
section 804 of the Federal Food, Drug, and Cosmetic Act and this part,
a laboratory must have an FDA inspection history and it must have
satisfactorily addressed any objectionable conditions or practices
identified during its most recent FDA inspection, if applicable.
    (c) To be considered a qualifying laboratory for purposes of
section 804 of the Federal Food, Drug, and Cosmetic Act and this part,
a laboratory must comply with the applicable current good manufacturing
practice requirements, including provisions regarding laboratory
controls in Sec.  211.160 of this chapter and laboratory records in
Sec.  211.194 of this chapter.

Sec.  251.16  Laboratory testing requirements.

    (a) The manufacturer or the Importer must arrange for drugs
imported under an authorized SIP to be tested by a qualifying
laboratory.
    (b) Unless the manufacturer conducts the Statutory Testing, in
accordance with this part, the manufacturer of the drugs imported under
an authorized SIP must supply to the Importer, within 30 calendar days
of receiving the Importer's request, all information needed to conduct
the Statutory Testing, including any testing protocols, Certificate of
Analysis, and samples of analytical reference standards that the
manufacturer has developed. The manufacturer must also provide the
Importer, within 30 calendar days of receiving the Importer's request,
with formulation information about the HPFB-approved drug, a stability-
indicating assay, and the FDA-approved drug to facilitate
authentication.
    (c) Testing done on a statistically valid sample of the batch or
shipment, as applicable, must be sufficiently thorough to establish, in
conjunction with data and information from the manufacturer, that the
batch or shipment is eligible for importation under a SIP. The size of
the sample must be large enough to enable a statistically valid
statement to be made regarding the authenticity and stability of the
quantity of the batch in the shipment or the entire shipment, as
applicable.
    (d) The statistically valid sample of the HPFB-approved drug must
be subjected to testing to confirm that the HPFB-approved drug meets
the FDA-approved drug's specifications and standards, which include the
analytical procedures and methods and the acceptance criteria. In
addition, to test for degradation, a stability-indicating assay
provided by the manufacturer must be conducted on the sample of the
drug that is proposed for import.
    (e) If the manufacturer performs the Statutory Testing at a
qualifying laboratory, the testing results, a complete set of
laboratory records, a detailed description of the selection method for
the samples, the testing methods used, complete data derived from all
tests necessary to ensure that the eligible prescription drug meets the
specifications and standards of the FDA-approved drug that are
established in the NDA or ANDA, a Certificate of Analysis, and any
other documentation demonstrating that the testing meets the
requirements under section 804 must be submitted in electronic format
directly to FDA via the ESG or to an alternative transmission point
identified by FDA. The manufacturer must notify the Importer and FDA of
the manufacturer's intent to perform the Statutory Testing, and
identify the qualifying laboratory for FDA review and approval pursuant
to section 804 of the Federal Food, Drug, and Cosmetic Act, within 30
calendar days of receipt of the request from the Importer described in
paragraph (b) of this section.
    (f) Regardless of whether testing under this section is performed
by the manufacturer or Importer, the sample of a batch or shipment of
drugs must be randomly selected for testing or, in the alternative, the
sample must be selected to be representative of the quantity of the
batch in a shipment or of a shipment, as applicable.
    (g) Information supplied by the manufacturer to authenticate the
prescription drug being tested and confirm that the labeling of the
prescription drug complies with labeling requirements under the Federal
Food, Drug, and Cosmetic Act, and any trade secrets or commercial or
financial information that is privileged or confidential that the
manufacturer supplies for the purposes of testing or otherwise
complying with the Federal Food, Drug, and Cosmetic Act and this part,
must be kept in strict confidence and used only for the purposes of
testing or otherwise complying with the Federal Food, Drug, and
Cosmetic Act and this part.

    (h) To ensure that the information described in paragraph (g) of
this section is protected:
    (1) The information that the manufacturer supplies about a
prescription drug must not be disseminated except for the purpose of
testing or otherwise complying with the Federal Food, Drug, and
Cosmetic Act and this part; and
    (2) The SIP Sponsor must take all of the steps set out in the
authorized SIP Proposal to ensure that the information is kept in
strict confidence and used only for the purpose of testing or otherwise
complying with the Federal Food, Drug, and Cosmetic Act and this part.

Sec.  251.17  Importation requirements.

    (a) Importers must ensure that each shipment of eligible
prescription drugs imported or offered for import pursuant to this part
is accompanied by an import entry for consumption filed electronically
as a formal entry in ACE, or another CBP-authorized electronic data
interchange system, and designated in such a system as a drug imported
pursuant to this part.
    (b) The Importer may make entry for consumption and arrival of
shipments containing eligible prescription drugs only at the CBP port
of entry authorized by FDA to import eligible prescription drugs under
section 804 of the Federal Food, Drug, and Cosmetic Act. The Importer
must keep the product at a secured warehouse, location within a
specific foreign trade zone, or other secure distribution facility
controlled by or under contract with the Importer, and under
appropriate environmental conditions to maintain the integrity of the
products, until FDA issues an admissibility decision. The secured
warehouse or other secure distribution facility must be within 30 miles
of the authorized Port of Entry for examination.
    (c) If the entry for consumption is filed in ACE before the testing
and relabeling of the eligible prescription drug, the Importer must
submit an application to bring the drug into compliance and must
relabel and test the drug in accordance with the plan approved by FDA
pursuant to Sec. Sec.  1.95 and 1.96 of this chapter.
    (d) Upon arrival in the United States of an initial shipment that
contains a batch of an eligible prescription drug identified in a Pre-
Import Request that has been granted by FDA, the Importer must select a
statistically valid sample of that batch to send to a qualifying
laboratory for Statutory Testing, unless the manufacturer conducts the
Statutory Testing at a qualifying laboratory.
    (1) In the case of any subsequent shipment composed entirely of a
batch of an eligible prescription drug that has already been tested in
accordance with this part, the Importer must select a statistically
valid sample of the shipment to send to a qualifying laboratory for
Statutory Testing.
    (2) The Importer must send three sets of the samples sent to the
qualifying laboratory in accordance with Sec.  251.16 to the FDA field
lab identified by FDA when the Agency granted the Pre-Import Request.
    (3) The Importer must submit to FDA a complete set of laboratory
records, a detailed description of the sampling method used to select
the sample of the eligible prescription drug sent to the qualifying
laboratory, the testing protocols used, complete data derived from all
tests necessary to ensure that the eligible prescription drug meets the
specifications of the FDA-approved drug that are established in the NDA
or ANDA, a Certificate of Analysis, and all relevant documentation
demonstrating that the testing meets the requirements under section
804(e)(1) of the Federal Food, Drug, and Cosmetic Act, as well as any
additional information FDA deems necessary to evaluate whether the drug
meets manufacturing, quality, and safety standards.
    (e) If the manufacturer conducts the Statutory Testing, upon
arrival in the United States of an initial shipment that contains a
batch of an eligible prescription drug identified in a Pre-Import
Request that has been granted by FDA, a statistically valid sample of
that batch must be selected to send to a qualifying laboratory for the
Statutory Testing.
    (1) In the case of any subsequent shipment composed entirely of a
batch or batches of an eligible prescription drug that has already been
tested in accordance with this part, the manufacturer must select a
statistically valid sample of that shipment to send to a qualifying
laboratory for that Statutory Testing.
    (2) The manufacturer must send three sets of the samples the
manufacturer sent to the qualifying laboratory in accordance with Sec.
251.16 to the FDA field lab identified by FDA when the Agency granted
the Pre-Import Request.
    (3) The manufacturer must submit to FDA, directly in electronic
form to the ESG or to an alternative transmission point identified by
FDA, a complete set of laboratory records, a detailed description of
the selection method for the sample of the eligible prescription drug
sent to the qualifying laboratory, the testing methods used, complete
data derived from all tests necessary to ensure that the eligible
prescription drug meets the conditions in the FDA-approved drug's NDA
or ANDA, a Certificate of Analysis, and all relevant documentation
demonstrating that the testing meets the requirements under section
804(e)(1) of the Federal Food, Drug, and Cosmetic Act, as well as any
additional information FDA deems necessary to evaluate whether the drug
meets manufacturing, quality, and safety standards.
    (f) After FDA has reviewed the testing results provided by the
Importer or manufacturer and determined that they are acceptable, FDA
will notify the Importer and then the Importer must cause the eligible
prescription drug to be relabeled with the required U.S. labeling.
    (g) After the eligible prescription drug has been shown by testing
and relabeling to meet the requirements of section 804 of the Federal
Food, Drug, and Cosmetic Act and this part, the Importer or the
manufacturer must provide to FDA the written certification described in
section 804(d)(1)(K) of the Federal Food, Drug, and Cosmetic Act in
electronic format via the ESG or to an alternative transmission point
identified by FDA.

Sec.  251.18  Post-importation requirements.

    (a) Stopping importation. If at any point a SIP Sponsor determines
that a drug, manufacturer, Foreign Seller, Importer, qualifying
laboratory, or other participant in or element of the supply chain in
the authorized SIP does not meet all applicable requirements of the
Federal Food, Drug, and Cosmetic Act, FDA regulations, and the
authorized SIP, the SIP Sponsor must immediately stop importation of
all drugs under the SIP, notify FDA, and demonstrate to FDA that
importation has in fact been stopped.
    (b) Field alert reports. Importers must submit NDA and ANDA field
alert reports, as described in Sec. Sec.  314.81(b)(1) and 314.98 of
this chapter, to the manufacturer and to FDA.
    (c) Additional reporting requirements for combination products. For
combination products containing a device constituent part, Importers
must submit the reports to the manufacturer and to FDA described in
Sec.  4.102(c)(1) of this chapter and maintain the records described in
Sec. Sec.  4.102(c)(1) and 4.105(b) of this chapter.
    (d) Adverse event reports--(1) Scope. An Importer must establish
and maintain records and submit to FDA and the manufacturer reports of
all adverse events associated with the use of its drug products
imported under this part.

    (2) Review of safety information. The Importer must promptly review
all domestic safety information for the eligible prescription drugs
obtained or otherwise received by the Importer.
    (3) Expedited ICSRs. The Importer must submit expedited ICSRs for
each domestic adverse event to FDA and the manufacturer as soon as
possible but no later than 15 calendar days from the date when the
Importer has both met the reporting criteria described in this
paragraph (d) and acquired a minimum data set for that adverse event.
    (i) Serious, unexpected adverse events. The Importer must submit
expedited ICSRs for domestic adverse events reported to the Importer
spontaneously (such as reports initiated by a patient, consumer, or
healthcare professional) that are both serious and unexpected, whether
or not the Importer believes the events are related to the product.
    (ii) Other adverse event reports to be expedited upon notification
by FDA. Upon notification by FDA, the Importer must submit as expedited
ICSRs any adverse event reports that do not qualify for expedited
reporting under paragraph (d)(3)(i) of this section. The notice will
specify the adverse events to be reported and the reason for requiring
the expedited reports.
    (4) Followup reports for expedited ICSRs. The Importer must
actively seek any missing data elements under paragraph (d)(7) of this
section or updated information for any previously submitted expedited
ICSR under paragraph (d)(3) of this section. The Importer must also
investigate any new information it obtains or otherwise receives about
previously submitted expedited ICSRs. The Importer must submit followup
reports for expedited ICSRs to FDA and the manufacturer as soon as
possible but no later than 15 calendar days after obtaining the new
information. The Importer must document and maintain records of its
efforts to obtain missing or incomplete information.
    (5) Nonexpedited ICSRs. The Importer must submit to FDA and the
manufacturer an ICSR for each domestic adverse event not reported under
paragraph (d)(3)(i) of this section (all serious, expected adverse
events and nonserious adverse events) within 90 calendar days from the
date when the Importer has both met the reporting criteria described in
this paragraph (d) and acquired a minimum data set for that adverse
event.
    (6) Completing and submitting safety reports. This paragraph (d)(6)
describes how to complete and submit ICSRs required under this section.
Additionally, upon written notice, FDA may require the Importer to
submit any of this section's adverse event reports at a different time
period than identified in paragraphs (d)(1) through (5) and (7) through
(11) of this section.
    (i) Electronic format for submissions. (A) ICSR and ICSR
attachments must be submitted in an electronic format that FDA can
process, review, and archive, as described in Sec.  314.80(g)(1) of
this chapter.
    (B) The Importer may request, in writing, a temporary waiver of the
requirements in paragraph (d)(6)(i)(A) of this section, as described in
Sec.  314.80(g)(2) of this chapter. These waivers will be granted on a
limited basis for good cause shown.
    (ii) Completing and submitting ICSRs--(A) Single submission. Submit
each ICSR only once.
    (B) Separate ICSR. The Importer must submit a separate ICSR for
each patient who experiences an adverse event reportable under
paragraph (d)(3)(i) or (ii) or (d)(4) or (5) of this section.
    (C) Coding terms. The adverse event terms described in the ICSR
must be coded using standardized medical terminology.
    (D) Minimum data set. All ICSRs submitted under this section must
contain at least the minimum data set for an adverse event. The
Importer must actively seek the minimum data set in a manner consistent
with its written procedures under paragraph (d)(9) of this section. The
Importer must document and maintain records of its efforts to obtain
the minimum data set.
    (E) ICSR elements. The Importer must complete all available
elements of an ICSR as specified in paragraph (d)(7) of this section.
    (1) The Importer must actively seek any information needed to
complete all applicable elements, consistent with its written
procedures under paragraph (d)(9) of this section.
    (2) The Importer must document and maintain records of its efforts
to obtain the missing information.
    (F) Supporting documentation. When submitting supporting
documentation for expedited ICSRs of adverse events, the Importer must:
    (1) Submit for each ICSR for a domestic adverse event, if
available, a copy of the autopsy report if the patient died, or a copy
of the hospital discharge summary if the patient was hospitalized. The
Importer must submit each document as an ICSR attachment. The ICSR
attachment must be submitted either with the initial ICSR or no later
than 15 calendar days after obtaining the document.
    (2) Include in the ICSR a list of available, relevant documents
(such as medical records, laboratory results, death certificates) that
are held in its drug product safety files. Upon written notice from
FDA, the Importer must submit a copy of these documents within 5
calendar days of the FDA notice.
    (7) Information reported on ICSRs. ICSRs must include the following
information:
    (i) Patient information, which includes:
    (A) Patient identification code;
    (B) Patient age at the time of adverse event, or date of birth;
    (C) Patient gender; and
    (D) Patient weight.
    (ii) Adverse event, which includes:
    (A) Outcome attributed to adverse event;
    (B) Date of adverse event;
    (C) Date of ICSR submission;
    (D) Description of adverse event (including a concise medical
narrative);
    (E) Adverse drug event term(s);
    (F) Description of relevant tests, including dates and laboratory
data; and
    (G) Other relevant patient history, including preexisting medical
conditions.
    (iii) Suspect medical product(s), which includes:
    (A) Name;
    (B) Dose, frequency, and route of administration used;
    (C) Therapy dates;
    (D) Diagnosis for use (indication);
    (E) Whether the product is a combination product;
    (F) Whether adverse event abated after drug use stopped or dose
reduced;
    (G) Whether adverse event reappeared after reintroduction of drug;
    (H) Lot number;
    (I) Expiration date;
    (J) NDC; and
    (K) Concomitant medical products and therapy dates.
    (iv) Initial reporter information, which includes:
    (A) Name, address, and telephone number;
    (B) Whether the initial reporter is a healthcare professional; and
    (C) Occupation, if a healthcare professional.
    (v) Importer information, which includes:
    (A) Importer name and contact office address;
    (B) Importer telephone number;
    (C) Date the report was received by the Importer;
    (D) Whether the ICSR is an expedited report;
    (E) Whether the ICSR is an initial report or followup report; and

    (F) Unique case identification number, which must be the same in
the initial report and any subsequent followup report(s).
    (8) Recordkeeping. (i) For a period of 10 years from the initial
receipt of information, the Importer must maintain records of
information relating to adverse event reports under this section,
whether or not submitted to FDA.
    (ii) These records must include raw data, correspondence, and any
other information relating to the evaluation and reporting of adverse
event information that is obtained by the Importer.
    (iii) Upon written notice by FDA, the Importer must submit any or
all of these records to FDA within 5 calendar days after receipt of the
notice. The Importer must permit any authorized FDA employee, at
reasonable times, to access, copy, and verify its established and
maintained records described in this section.
    (9) Written procedures. The Importer must develop written
procedures needed to fulfill the requirements in this section for the
surveillance, receipt, evaluation, and reporting to FDA and the
manufacturer of adverse event information, including procedures for
employee training, and for obtaining and processing safety information
from the Foreign Seller.
    (10) Patient privacy. The Importer must not include in reports
under this section the names and addresses of individual patients;
instead, the Importer must assign a unique code for identification of
the patient. The Importer must include the name of the reporter from
whom the information was received as part of the initial reporter
information, even when the reporter is the patient. As set forth in
FDA's public information regulations in part 20 of this chapter, FDA
generally may not disclose the names of patients, individual reporters,
healthcare professionals, hospitals, and geographical identifiers
submitted to FDA in adverse event reports.
    (11) Safety reporting disclaimer. (i) A report or information
submitted by the Importer under this section (and any release by FDA of
that report or information) does not necessarily reflect a conclusion
by the Importer or by FDA that the report or information constitutes an
admission that the eligible prescription drug imported under section
804 of the Federal Food, Drug, and Cosmetic Act caused or contributed
to an adverse event.
    (ii) The Importer need not admit, and may deny, that the report or
information submitted as described in this section constitutes an
admission that the drug product caused or contributed to an adverse
event.
    (e) Drug recalls. (1) The SIP Sponsor must establish a procedure to
track the public announcements of the manufacturer of each drug it
imports under section 804 of the Federal Food, Drug, and Cosmetic Act,
and the SIP Sponsor must also monitor FDA's recall website for recall
or market withdrawal information relevant to the drugs that it imports
under section 804.
    (2) If FDA, the SIP Sponsor, the Foreign Seller, the Importer, or
the manufacturer determines that a recall is warranted, the SIP Sponsor
must effectuate the recall in accordance with its written recall plan
under paragraph (e)(3) of this section.
    (3) A SIP must have a written recall plan that describes the
procedures to perform a recall of the product and specifies who will be
responsible for performing the procedures. The recall plan must cover
recalls mandated or requested by FDA and recalls initiated by the SIP
Sponsor, the Foreign Seller, the Importer, or the manufacturer. The
recall plan must include sufficient procedures for the SIP Sponsor to:
    (i) Immediately cease distribution of the drugs affected by the
recall;
    (ii) Directly notify consignees of the drug(s) included in the
recall, including how to return or dispose of the recalled drugs;
    (iii) Specify the depth to which the recall will extend (e.g.,
wholesale, intermediate wholesale, retail or consumer level) if not
specified by FDA;
    (iv) Notify the public about any hazard(s) presented by the
recalled drug when appropriate to protect the public health;
    (v) Conduct effectiveness checks to verify that all consignees at
the specified recall depth have received notification about the recall
and have taken appropriate action;
    (vi) Appropriately dispose of recalled product; and
    (vii) Notify FDA of the recall.
    (4) In the event of a recall, the Importer must, upon request by
FDA, provide transaction history, information, and statement (as these
terms are defined in sections 581(25), 581(26), and 581(27) of the
Federal Food, Drug, and Cosmetic Act), in accordance with applicable
requirements under sections 582(c)(1)(C) and 582(d)(1)(D).
    (i) The Importer must also provide to FDA, upon request,
information given by the manufacturer under Sec.  251.14(a)(6),
including transaction documents that were provided from the
manufacturer to the Foreign Seller.
    (ii) The Foreign Seller must provide to FDA, upon request,
information about its transactions of the recalled drug with the
manufacturer and the Importer.
    (5) The Foreign Seller and Importer must cooperate with any
recalls, including recalls initiated by the SIP Sponsor, FDA, the
Foreign Seller, the Importer, or the drug's manufacturer.

Sec.  251.19  Reports to FDA.

    (a) A SIP Sponsor must submit a report to FDA each quarter in
electronic format via the ESG or to an alternative transmission point
identified by FDA containing the information set forth in this section,
beginning after the SIP Sponsor files an electronic import entry for
consumption for its first shipment of drugs under the SIP. If the SIP
Sponsor specifies in such report that the information contained in the
report is being transmitted on behalf of the Importer and in order to
fulfill the Importer's obligation under Sec.  251.12, the Importer need
not separately submit such information to FDA.
    (b) The report in paragraph (a) of this section must contain the
following information:
    (1) The name, address, telephone number, and professional license
number (if any) of the Importer;
    (2) The name and quantity of the active ingredient of the imported
eligible prescription drug(s);
    (3) A description of the dosage form of the eligible prescription
drug(s);
    (4) The date(s) on which the eligible prescription drug(s) were
shipped;
    (5) The quantity of the eligible prescription drug(s) that was
shipped;
    (6) The lot or control number assigned to the eligible prescription
drug(s) by the manufacturer of the eligible prescription drug(s);
    (7) The point of origin (i.e., the manufacturer) and the
destination (i.e., the wholesaler, pharmacy, or patient to whom the
Importer sells the drug) of the eligible prescription drug(s);
    (8) The per unit price paid by the Importer for the prescription
drug(s) in U.S. dollars; and
    (9) Any other information that FDA determines is necessary for the
protection of the public health.
    (c) The Importer must also confirm as part of the report in
paragraph (a) of this section that the eligible prescription drug(s)
were bought directly from the manufacturer by the Foreign Seller and
that the Foreign Seller sold the eligible prescription drug(s) directly
to the Importer.
    (d) The report in paragraph (a) of this section must include the
following documentation:
    (1) Documentation from the Foreign Seller specifying the
manufacturer of

each eligible prescription drug and the quantity of each lot of the
eligible prescription drug(s) received by the Foreign Seller from that
manufacturer;
    (2) Documentation demonstrating that the eligible prescription drug
was received by the Foreign Seller from the manufacturer and
subsequently shipped by the Foreign Seller to the Importer;
    (3) Documentation of the quantity of each lot of the eligible
prescription drug(s) received by the Foreign Seller, demonstrating that
the quantity being imported into the United States is not more than the
quantity that was received by the Foreign Seller; and
    (4) Documentation demonstrating that the sampling and testing
requirements described in section 804(d)(1)(J)(i)(III) of the Federal
Food, Drug, and Cosmetic Act were met for each shipment of each
eligible prescription drug.
    (e) The report in paragraph (a) of this section must include
certifications from the Importer for each shipment of each eligible
prescription drug that the drug is approved for marketing in the United
States and is not adulterated or misbranded and meets all labeling
requirements under the Federal Food, Drug, and Cosmetic Act. This
certification must include:
    (1) That there is an authorized SIP;
    (2) That the imported drug is covered by the authorized SIP;
    (3) That the drug is an eligible prescription drug as defined in
this part;
    (4) That the FDA-approved counterpart of the drug is currently
commercially marketed in the United States;
    (5) That the drug is approved for marketing in Canada; and
    (6) That the drug is not adulterated or misbranded and meets all
labeling requirements under the Federal Food, Drug, and Cosmetic Act.
    (f) The report in paragraph (a) of this section must include
laboratory records, including complete data derived from all tests
necessary to ensure that each eligible prescription drug is in
compliance with established specifications and standards, and
documentation demonstrating that the Statutory Testing was conducted at
a qualifying laboratory, unless the manufacturer conducted the testing
and submitted this information directly to FDA.
    (g) The report in paragraph (a) of this section must include data,
information, and analysis on the SIP's cost savings to the American
consumer for the drugs imported under the SIP.
    (h) A SIP Sponsor must submit a report to FDA within 10 calendar
days, in electronic format via the ESG or to an alternative
transmission point identified by FDA, regarding any applicable criminal
conviction, violation of law, or disciplinary action as described in
Sec.  251.3(e)(2) and (3).

Sec.  251.20  Severability.

    The provisions of this part are not separate and are not severable
from one another. If any provision is stayed or determined to be
invalid or unenforceable, the remaining provisions shall not continue
in effect.

Sec.  251.21  Consequences for violations.

    (a) An article that is imported or offered for import into the
United States in violation of section 804 of the Federal Food, Drug,
and Cosmetic Act or this part is subject to refusal under section 801
of the Federal Food, Drug, and Cosmetic Act.
    (b) The importation of a prescription drug in violation of section
804 of the Federal Food, Drug, and Cosmetic Act; the falsification of
any record required to be maintained or provided to FDA under section
804; or any other violation of this part is a prohibited act under
section 301(aa) of the Federal Food, Drug, and Cosmetic Act.

    Dated: September 23, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-21522 Filed 9-25-20; 4:15 pm]
 BILLING CODE 4164-01-P


[Federal Register: May 13, 2009 (Volume 74, Number 91)]
[Notices]
[Page 22632]
[DOCID:fr13my09-114]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-26367]

Motor Carrier Safety Advisory Committee Public Meeting

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of Motor Carrier Safety Advisory Committee meeting,
amendment.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces an amendment to its May 5, 2009, notice
regarding the May meeting of the Motor Carrier Safety Advisory
Committee (MCSAC). The public session scheduled for May 18, from 10
a.m.-11 a.m. will be combined with the public session scheduled on May
20 from 1 p.m. to 4 p.m.

DATES: The MCSAC will hold a public session on Wednesday, May 20, 2009,
from 1 p.m. to 4 p.m. (EDT).

FOR FURTHER INFORMATION CONTACT: Mr. Jeffrey K. Miller, Chief,
Strategic Planning and Program Evaluation Division, Office of Policy
Plans and Regulation, Federal Motor Carrier Safety Administration, U.S.
Department of Transportation, 1200 New Jersey Avenue, SE., Washington,
DC 20590,<PHONE_NUMBER><EMAIL_ADDRESS>
Background

    On May 5, 2009, FMCSA announced that its MCSAC will hold a public
meeting via teleconference on May 18, 2009, from 10 a.m.-11 a.m. The
notice also announced that FMCSA's MCSAC will hold a public meeting on
Wednesday, May 20, 2009, from 1 p.m.-4 p.m. at the U.S. Department of
Transportation, Media Center, West Building, Ground Floor, 1200 New
Jersey Avenue, SE., Washington, DC 20590. The public meeting scheduled
for May 18 is being combined with the public session scheduled for May
20. The May 20 session will now be used to allow all interested parties
to listen to the MCSAC members discuss all topics for which the
committee will provide recommendations to FMCSA during its May meeting.
    The Committee will allocate one hour for public comments on May 20,
2009, from 3 p.m. to 4 p.m. Individuals wishing to address the
committee should send an e-mail to<EMAIL_ADDRESS>by May 13, 2009. The
time available will be divided among those who have signed up to
address the committee with no one being allotted more than 15 minutes.
For a copy of the agenda, please send an e-mail to<EMAIL_ADDRESS>    Should you wish to attend the meeting on May 20, 2009, please e-
mail<EMAIL_ADDRESS>by May 15, 2009, to facilitate the pre-clearance
security process and expedite entry into the building. For information
on facilities or services for individuals with disabilities or to
request special assistance at the meeting, please e-mail<EMAIL_ADDRESS>by May 15, 2009.

    Issued on: May 8, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-11177 Filed 5-12-09; 8:45 am]

BILLING CODE 4910-EX-P