(8) 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 evidence of
registration and of satisfactory resolution of any objectionable
conditions or practices identified during its most recent FDA
inspection, if applicable;
    (9) A summary of how the SIP Sponsor will ensure:
    (i) That the imported eligible prescription drugs meet the
Statutory Testing requirements;
    (ii) That the supply chain is secure;
    (iii) That the labeling requirements of the Federal Food, Drug, and
Cosmetic Act and this part are met;
    (iv) That the post-importation pharmacovigilance and other
requirements of the Federal Food, Drug, and Cosmetic Act and this part
are met; and
    (v) That the SIP Proposal would result in a significant reduction
in the cost to the American consumer of the prescription drugs that the
SIP Sponsor seeks to import.
    (d) The SIP Sponsor's importation plan must:
    (1) Identify the SIP Sponsor, including any co-sponsors, and
identify the finished dosage form manufacturer of each prescription
drug that the SIP Sponsor seeks to include in the SIP, the Foreign
Seller, and the Importer, and explain the legal relationship of each of
these entities to the SIP Sponsor, if any.
    (2) Include an attestation containing a complete disclosure of any
past criminal convictions or violations of the State, Federal, or
Canadian laws regarding drugs or devices against the Foreign Seller or
Importer or an attestation that the Foreign Seller or Importer has not
been involved in, or convicted of, any such criminal or prohibited
acts. Such attestation 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 Foreign Seller or
the Importer by State, Federal, or Canadian regulatory bodies,
including any such actions against the principals, owners, directors,
officers, 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 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 Foreign Seller has been licensed
for less than 5 years, for the duration of its period of licensure.
    (5) Include the proprietary and established names, 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. It 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) Confirm that each HPFB-approved drug's FDA-approved counterpart
drug is currently 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. It
must also identify the qualifying laboratory that will conduct the
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 labeling for the FDA-
approved version 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, if applicable, any patient labeling, 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 expects that the SIP will result in
a significant reduction in the cost to the American consumer of the
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 of 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 minimum
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, or expired; and
    (iv) Importer fulfills its responsibilities to submit adverse
event, medication error, field alert, and other reports.
    (12) Explain how the SIP Sponsor will educate pharmacists,
healthcare providers, and patients about the 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; and
    (14) Explain how the SIP Sponsor will ensure that any information
that the manufacturer provides to the Importer to allow the Importer to
conduct the Statutory Testing, or information otherwise obtained by the
Importer for such purposes, would be kept in strict confidence and used
only for purposes of testing or otherwise complying with the Federal
Food, Drug, and Cosmetic Act, as required by section 804(e)(2)(B).

Sec.  251.4   Review and authorization of importation program
proposals.

    Based on a review of a SIP Proposal submitted under this part, FDA
may authorize, modify, or extend the authorization period of a SIP that
meets the requirements of this part. FDA may deny a request for
authorization, modification, or extension of a SIP in its discretion,
including if a proposed SIP does not meet the standard for authorizing
a SIP under this part. Where a SIP Proposal meets the requirements of
this part, FDA may nonetheless decide, in its discretion, not to
authorize the SIP Proposal.
    (a) Among other reasons, FDA may decide not to authorize a SIP
Proposal because of potential safety concerns with the SIP, because of
the degree of uncertainty that the SIP Proposal would adequately ensure
the protection of public health, because, based on the recommendation
of another Health and Human Services (HHS) component as directed by the
Secretary, the relative likelihood that the SIP Proposal would not
result in significant cost savings, or in order to limit the number of
authorized SIP programs 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, including through
electronic means, when FDA receives the SIP Sponsor's SIP 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.
    (2) FDA will notify a SIP Sponsor in writing, including through
electronic means, whether FDA has decided to authorize or not to
authorize the SIP Sponsor's SIP Proposal.

Sec.  251.5   Pre-Import Request.

    (a) A 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, which has been granted by FDA.
    (b) The Importer must submit a complete Pre-Import Request at least
30 days prior to 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 name of a
contact person with their email and phone number.
    (2) Identification of the FDA-authorized SIP including the name of
the SIP; 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 pharmacy
regulatory body, and the name, email address, and phone number of a
contact person.
    (4) Identification and description of the drug(s) covered by the
Pre-Import Request, including the following information:
    (i) Established and trade name of the HPFB-approved drug(s), as
applicable, DIN, and complete product description including strength,
description of dosage form, and route 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 each eligible prescription
drug;
    (iii) Established name and trade name, as applicable, of FDA-
approved counterpart drug(s) 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 drugs to the Foreign Seller 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 each 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 each HFPB-approved drug, listed by lot or
control number.
    (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 calculated to comply 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) 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, if the Importer will be conducting the
Statutory Testing, or the description of the testing methods must be
submitted by the manufacturer to FDA directly under Sec.  251.17 if the
manufacturer will be conducting the Statutory Testing.
    (xii) Attestation from the manufacturer that must establish 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 must include:
    (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 specifications 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(a)(2)(B) 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 that meets the specifications of
the FDA-approved drug's NDA or ANDA.
    (E) Information needed to confirm that the labeling of the
prescription drug complies with labeling requirements of 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 eligible prescription drug(s) will
leave their location in Canada);
    (B) Name, address, email, and telephone number of the Foreign
Shipper;
    (C) Anticipated date of export from Canada and Canadian port of
exportation;
    (D) Anticipated date and approximate time of arrival at a 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
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(s) will be stored pending
testing, relabeling, and FDA determination of admissibility;
    (F) Information regarding the facility where the relabeling and any
limited repackaging activities will occur for all eligible prescription
drugs covered by this Pre-Import Request, 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) If the manufacturer conducts the Statutory Testing, the
manufacturer must provide the attestation to FDA. If the Importer
conducts the Statutory Testing, the manufacturer must provide the
attestation to the Importer.
    (e)(1) The Importer must provide the executed batch record,
including the executed 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 analyses for each
manufacturing line that the manufacturer used to produce either or both
of the drugs.

Sec.  251.6  Limitations on authorized importation programs.

    (a) Unless an extension is granted under this section,
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 2-year authorization period for a SIP begins when the
Importer 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 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 that includes a notice of the SIP Sponsor's intent to
discontinue its activities.

Sec.  251.7  Suspension and revocation of authorized importation
programs.

    (a) FDA may suspend a SIP under the circumstances set forth in
Sec.  251.18, or under other circumstances in FDA's discretion.
Importation of drugs under a SIP that has been suspended is prohibited.
    (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 or inspection of their facility
or their records, any drug that has been held by such entity will be
deemed to be adulterated and the SIP may be suspended, 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 for
any reason if FDA determines, in its discretion, or on the
recommendation of another HHS component as directed by the Secretary,
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 the manufacturer, the Foreign Seller, the
Importer, or any other SIP entity is found to be not compliant with
section 501(a)(2)(A) or (B) of the FD&C Act;
    (4) Continued implementation of the SIP is 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 will not 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 drain on
FDA or HHS resources or is inconsistent with FDA or HHS prioritization
of resources; or
    (8) Continued implementation of the SIP is otherwise inappropriate.

Sec.  251.8  Modification or extension of authorized importation
programs.

    (a) A supplement to modify or extend an authorized SIP must be
submitted via the ESG for FDA's consideration.
    (b) A SIP Sponsor can propose to add additional Foreign Sellers or
additional Importers to an authorized SIP once it has consistently
imported eligible prescription drugs in accordance with section 804 of
the Federal Food, Drug, and Cosmetic Act and this part.
    (c) If FDA authorizes changes to the SIP, the Importer must submit
a new Pre-Import Request in accordance with Sec.  251.5.
    (d) A SIP Sponsor must not make any changes or permit any changes
to be made to a SIP without first securing FDA's authorization. If FDA
authorizes changes to a SIP under this section, such authorization does
not change the authorization of the original SIP.
    (e) A SIP Sponsor may request that FDA extend the authorization
period of an authorized SIP. Such a request must be submitted via the
ESG for FDA's consideration at least 3 months 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, in its sole discretion,
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) Foreign Sellers must be registered with FDA before FDA will
authorize a 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, telephone number(s), and email address of the
Foreign Seller;
    (4) Registration number, if previously assigned by FDA;
    (5) A copy of the Foreign Seller's Health-Canada Drug Establishment
License;
    (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 their 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 consistent
with that of an 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, or expired;
    (4) Ensuring the eligible prescription drug is relabeled with the
required U.S. labeling, including the container and carton labels;
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, medication error, 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 a prescription drug must provide an Importer written authorization
for the Importer to use, at no cost, the FDA-approved labeling for the
prescription drug. If the manufacturer fails to do so within a timely
fashion, 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) If the Importer is a private label distributor, take
responsibility to ensure that the entity performing relabeling on its
behalf proposes an NDC and lists each eligible prescription drug 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 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) The label of the drug must be the same as the label authorized
by the approved NDA or ANDA of the FDA-approved drug, except that the
label 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; and
    (ii) The name and place of business of the manufacturer and the
Importer.
    (5) The container label must include at a minimum the product's
proprietary and established name (if any); product strength; lot
number; and the name of the manufacturer and the Importer.
    (6) Labeling on or within the package from which the eligible
prescription drug is to be dispensed is the same as the labeling
authorized by the NDA or the ANDA of the FDA-approved drug, except
that:
    (i) The labeling must bear the statement: ``This drug was imported
from Canada under the [Name of State or Other Governmental Entity and
of Its Co-Sponsors, If Any] Section 804 Importation Program to reduce
its cost to the American consumer.'' If the SIP maintains a website,
the statement could also include the website address. This statement
must be included after the PATIENT COUNSELING INFORMATION section for
products subject to Sec. Sec.  201.56(d) and 201.57 of this chapter, or
after the HOW SUPPLIED section (or after the last section of labeling)
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
and outside package;
    (ii) 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 U.S.
versions of the drug; and
    (iii) 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 must be included in the HOW SUPPLIED section in
place of the NDC(s) assigned to the FDA-approved U.S. versions of the
drug.
    (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.

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

    (a) SIP Sponsors. 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 from the point of manufacture until 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 labeled by the manufacturer for the
Canadian market before importation under the SIP (i.e. the drug 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; and
    (5) The Importer(s) and Foreign Seller(s) identified in the SIP
meet the applicable requirements of this part and in section 582(c) and
(d) of the Federal Food, Drug, and Cosmetic Act.
    (b) Manufacturer. The manufacturer must provide to the Importer a
copy of any 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 (such product may be further distributed).
    (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 the
Secretary (or other appropriate Federal or State official) upon request
by the Secretary (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 FDA, the Importer, or
other authorized repackager, 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 a SSI to each package and homogenous case intended for
sale to the Importer in the United States, unless each such package and
homogenous case contains 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; and
    (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.
    (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 other
such reasonable time as determined by the Secretary, based on the
circumstances of the request, notify the person making the request
whether the product identifier, including the standardized numerical
identifier, 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 a product identifier 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 has reason to believe the product is an illegitimate
foreign product, the Foreign Seller must advise the person making the
request of such belief 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 received the product from
an FDA-registered manufacturer;
    (ii) The proprietary or 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;
    (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 a product 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. 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 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.
    (3) The repackager or relabeler that affixes or imprints the
product identifier to each package and homogenous case of an eligible
prescription drug in accordance with section 582 of the Federal Food,
Drug, and Cosmetic Act--
    (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 no 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 original manufacturer. An
Importer must also have processes in place to, upon receipt of a 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.
    (5) 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.
    (6) For transactions of eligible prescription drugs between
Importers and Foreign Sellers, an Importer is exempt from the following
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
section 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 section
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 section 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
section 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 elements of current good
manufacturing practice requirements, including but not limited to
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 eligible
prescription drugs to be tested by a qualifying laboratory.
    (b) If the tests are conducted by the Importer, the manufacturer of
the

prescription drug must supply to the Importer all information needed to
authenticate the prescription drug being tested, including any
necessary testing methodologies and protocols that the manufacturer has
developed. The manufacturer must also provide the Importer with
formulation information about the HPFB-approved drug 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, including the analytical
procedures and methods and the acceptance criteria. In addition, to
testing 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 testing required under section
804(e)(1) of the Federal Food, Drug, and Cosmetic Act 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 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(e)(1) of the
Federal Food, Drug, and Cosmetic Act must be submitted in electronic
form directly to FDA via the ESG or to an alternative transmission
point identified by FDA.
    (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 under this part must be kept in strict
confidence by the recipient and only for the purpose of testing or
otherwise complying with this part.
    (h) To ensure that trade secret and commercial or financial
information is protected:
    (1) The information that the manufacturer provides must not be
disseminated except to the qualifying laboratory and to FDA; and
    (2) The SIP Sponsor must explain how it will ensure that the
information is not disseminated beyond the qualifying laboratory.
    (i) FDA may transmit information that the manufacturer is required
to provide to an Importer under this section on the manufacturer's
behalf if the manufacturer has not transmitted such information to the
Importer in a timely fashion and if such information is available to
FDA in the NDA or ANDA.

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 designated secured warehouse, and under
appropriate environmental conditions to maintain the integrity of the
products, until FDA issues an admissibility decision. The secured
warehouse 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 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
specifications of the FDA-approved drug that are established in the NDA
or ANDA, a complete 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, the manufacturer must select a
statistically valid sample of that batch 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 complete 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 the written certification described in
section 804(d)(1)(K) of the Federal Food, Drug, and Cosmetic Act to
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 in fact meet all applicable requirements of
the Federal Food, Drug, and Cosmetic Act, FDA regulations, and the
authorized SIP, the SIP Sponsor immediately must 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 and medication error reports. (1) Scope. An
Importer must establish and maintain records and submit reports to FDA
and the manufacturer of all adverse events and medication errors
associated with the use of their 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 or medication error 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 or medication error.
    (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.
    (iii) ICSRs for medication errors. The Importer must submit an
expedited ICSR for each domestic medication error. If the report also
involves one or more adverse events, the Importer must comply with all
adverse event reporting requirements in this section and submit one
ICSR describing both the medication error and the adverse event(s).
    (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 their
efforts to obtain missing or incomplete information.
    (5) Nonexpedited ICSRs. The Importer must submit an ICSR for each
domestic adverse event not reported under paragraph (d)(3)(i) of this
section (all serious, expected and nonserious adverse drug experiences)
to FDA and the manufacturer within 90 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 expedited ICSRs required under
this section. Additionally, upon written notice, FDA may require the
Importer to submit any of this section's adverse event and medication
error safety reports at a different time period than identified in
other paragraphs.
    (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) Labeling. Each ICSR must be accompanied by a copy of the
current U.S. labeling as an ICSR attachment unless it is already on
file at FDA as part of the SIP.
    (C) Separate ICSR. The Importer must submit a separate ICSR for:
    (1) Each patient who experiences an adverse event reportable under
paragraphs (d)(3)(i) or (ii), (d)(4), or (d)(5) of this section.
    (2) Each medication error reportable under paragraph (d)(3)(iii) of
this section. For reports that include both a medication error and an
adverse event, the Importer need only submit one ICSR describing both
the medication error and the adverse event.
    (D) Coding terms. The adverse event and medication error terms
described in the ICSR must be coded using standardized medical
terminology.
    (E) Minimum data set. All ICSRs submitted under this section must
contain at least the minimum data set appropriate to the type of report
(adverse event or medication error). 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 their efforts to obtain the minimum data set.
    (F) 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 their written
procedures under paragraph (d)(9) of this section.
    (2) The Importer must document and maintain records of their
efforts to obtain the missing information.
    (G) 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 their 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 medication error,
or date of birth;
    (C) Patient gender; and
    (D) Patient weight.
    (ii) Adverse event or medication error.
    (A) Outcome attributed to adverse event or medication error;
    (B) Date of adverse event or medication error;
    (C) Date of ICSR submission;
    (D) Description of adverse event or medication error (including a
concise medical narrative);
    (E) Adverse drug event or medication error terms(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.
    (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 events and medication error safety 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
events and medication error safety 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, maintain, and
follow written procedures needed to fulfill the requirements in this
section for the surveillance, receipt, evaluation, and reporting to FDA
and the manufacturer of adverse events and medication error safety
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. The names of
patients, individual reporters, healthcare professionals, hospitals,
and geographical identifiers in reports are not releasable to the
public under FDA's public information regulations in part 20 of this
chapter.
    (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 or a medication error.
    (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 or a medication error.
    (e) Drug recalls. (1) The SIP Sponsor must establish a procedure to
track the public announcements of the manufacturer of each drug they
import under section 804 of the Federal Food, Drug, and Cosmetic Act
and they must also monitor FDA's recall website for recall or market
withdrawal information relevant to the drugs that they import under
section 804.
    (2) If FDA or any participant in a SIP 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 initiated by FDA, recalls initiated by the Foreign Seller or by
the Importer, and recalls initiated by a drug's manufacturer, with
which the Foreign Seller and/or Importer must cooperate. The recall
plan must include sufficient procedures for the SIP 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);
    (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, Importers and Foreign sellers 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).

Sec.  251.19   Reports to FDA.

    (a) A SIP Sponsor must submit a report to FDA each quarter
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 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
drugs;
    (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 that the eligible prescription
drugs was 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 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;
    (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 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.
    (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 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 must include data, information, and analysis on the
SIP's cost savings to the American consumer for the drugs imported
under the SIP.

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, 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 such
section, or any other violation of this part is a prohibited act under
section 301(aa) of the Federal Food, Drug, and Cosmetic Act.

    Dated: December 11, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27474 Filed 12-18-19; 8:45 am]
 BILLING CODE 4164-01-P