[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8884-8886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1524]


Repackaging of Certain Human Drug Products by Pharmacies and 
Outsourcing Facilities; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Repackaging of Certain Human Drug Products by Pharmacies and 
Outsourcing Facilities.'' This guidance describes the conditions under 
which FDA does not intend to take action for violations of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act), when a state-licensed 
pharmacy, a Federal facility, or an outsourcing facility repackages 
human drug products.
    When this guidance becomes final, the Agency may also consider 
withdrawing or revising other guidance documents that address human 
drug repackaging, including section 446.100 of the Compliance Program 
Guidance (CPG) Manual, entitled ``Regulatory Action Regarding Approved 
New Drugs and Antibiotic Drug Products Subjected to Additional 
Processing or other Manipulations,'' which was issued in January 1991, 
and section 460.100 of the CPG Manual, entitled ``Hospital Pharmacies--
Status as Drug Manufacturer,'' which was issued in October 1980.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 20, 2015.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gail Bormel, Food and Drug 
Administration, 10001 New Hampshire Ave., Silver Spring, MD 20903, 301-
796-3110.

SUPPLEMENTARY INFORMATION: 

I. Announcement of Draft Guidance

    FDA is announcing the availability of a draft guidance for industry 
entitled

[[Page 8885]]

``Repackaging of Certain Human Drug Products by Pharmacies and 
Outsourcing Facilities.'' FDA regards repackaging as the act of taking 
a finished drug product from the container in which it was distributed 
by the original manufacturer and placing it into a different container 
without further manipulation of the drug. If a drug is manipulated in 
any other way, including if the drug is reconstituted, diluted, mixed, 
or combined with another ingredient, that act is not considered 
repackaging.
    Repackaged drugs are generally not exempt from any of the 
provisions of the FD&C Act related to the production of drugs. For 
example, repackaged drugs are generally subject to the premarket 
approval, misbranding, and adulteration provisions of the FD&C Act, 
including section 505 (concerning new drug applications), section 
502(f)(1) (concerning labeling with adequate directions for use), and 
section 501(a)(2)(B) (concerning current good manufacturing practice 
(CGMP) (21 U.S.C. 355, 352(f)(1), and 351(a)(2)(B) of the FD&C Act).
    Further, drugs that are repackaged are not subject to sections 503A 
and 503B of the FD&C Act (21 U.S.C. 353a and 353b). Therefore, drugs 
repackaged by state-licensed pharmacies, Federal facilities, or 
outsourcing facilities are not eligible for the exemptions provided 
under those sections.
    This draft guidance describes the conditions under which FDA does 
not intend to take action for violations of sections 505, 502(f)(1), 
and, where specified in the guidance, section 501(a)(2)(B) of the FD&C 
Act, when a state-licensed pharmacy, Federal facility, or registered 
outsourcing facility repackages drug products. The guidance does not 
address repackaging of nonprescription drugs; drugs that are intended 
for use in animals; biological products subject to licensure under 
section 351 of the Public Health Services Act (42 U.S.C. 262); 
repackaging by entities that are not state-licensed pharmacies, Federal 
facilities, or registered outsourcing facilities; removing a drug 
product from the original container at the point of care for immediate 
administration to a single patient after receipt of a patient-specific 
prescription or order for that patient; or repackaging a solid oral 
dosage form drug product by a state-licensed pharmacy for purposes of 
dispensing the drug to a patient upon receipt of an individual patient-
specific prescription.
    Elsewhere in this issue of the Federal Register, the Agency is 
making available for comment a draft guidance entitled ``Mixing, 
Diluting, or Repackaging of Biological Products Outside the Scope of an 
Approved Biologics License Application.'' When these two guidances 
become final, they will address and clarify the Agency's policy 
regarding hospital pharmacies repackaging and safely transferring 
repackaged drugs to other hospitals within the same health system 
during a drug shortage. Therefore, under section 506F(d) of the FD&C 
Act, when FDA issues these as final guidances, section 506F will no 
longer apply.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This guidance, when 
finalized, will represent FDA's current thinking on repackaging human 
drug products by pharmacies, Federal facilities, and outsourcing 
facilities. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Amendment or Withdrawal of Repackaging Guidance Documents

    When this guidance becomes final, the Agency may also consider 
withdrawing or revising other guidance documents that address human 
drug repackaging. These may include section 446.100 of the CPG Manual, 
entitled ``Regulatory Action Regarding Approved New Drugs and 
Antibiotic Drug Products Subjected to Additional Processing or other 
Manipulations,'' which was issued in January 1991, and section 460.100 
of the CPG Manual, entitled ``Hospital Pharmacies--Status as Drug 
Manufacturer,'' which was issued in October 1980.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of the information collection 
are given under this section with an estimate of the annual reporting 
and recordkeeping burdens. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    We invite comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Repackaging of Certain Human Drug Products by Pharmacies and 
Outsourcing Facilities; Guidance for Industry.
    Description: The draft guidance describes repackaging by state-
licensed pharmacies, Federal facilities, and outsourcing facilities 
under section 503B of the FD&C Act, and it describes the conditions 
under which FDA does not intend to take action for violations of 
sections 505, 502(f)(1), and where specified, section 501(a)(2)(B) of 
the FD&C Act, when a state-licensed pharmacy, or Federal facility, or 
an outsourcing facility repackages drug products. The draft guidance 
includes the following collection of information under the PRA:
    One condition in the draft guidance is that if a drug is repackaged 
by an outsourcing facility, the label on the immediate container 
(primary packaging, e.g., the syringe) of the repackaged product 
includes the following information:
    <bullet> The statement ``This drug product was repackaged by [name 
of outsourcing facility].''
    <bullet> The address and phone number of the outsourcing facility 
that repackaged the drug product.
    <bullet> The established name of the original, approved drug 
product that was repackaged.
    <bullet> The lot or batch number of the repackaged drug product.
    <bullet> The dosage form and strength of the repackaged drug 
product.

[[Page 8886]]

    <bullet> A statement of either the quantity or volume of the 
repackaged drug product, whichever is appropriate.
    <bullet> The date the drug product was repackaged.
    <bullet> The beyond-use-date of the repackaged drug product.
    <bullet> Storage and handling instructions for the repackaged drug 
product.
    <bullet> The National Drug Code (NDC) number of the repackaged drug 
product, if available.\1\
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    \1\ The NDC number of the original approved drug product should 
not be placed on the repackaged drug product.
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    <bullet> The statement ``Not for resale,'' and, if the drug is 
distributed by an outsourcing facility other than pursuant to a 
prescription for an individual identified patient, the statement 
``Office Use Only.''
    <bullet> If included on the label of the FDA-approved drug product 
from which the drug product is being repackaged, a list of the active 
and inactive ingredients, unless such information is included on the 
label for the container from which the individual units are removed, as 
described in this document.
    In addition, a condition in the draft guidance is that the label on 
the container from which the individual units are removed for 
administration (secondary packaging, e.g., the bag, box, or other 
package in which the repackaged products are distributed) includes the 
active and inactive ingredients, if the immediate product label is too 
small to include this information, and directions for use, including, 
as appropriate, dosage and administration, and the following 
information to facilitate adverse event reporting: http://www.fda.gov/medwatch and 1-800-FDA-1088.
    Another condition in the draft guidance is that each repackaged 
drug product is accompanied by a copy of the prescribing information 
that accompanied the original drug product that was repackaged.
    We estimate that annually a total of approximately 10 outsourcing 
facilities (``Number of Respondents'' in table 1, row 1) will each 
design, test, and produce approximately 10 different labels 
(``Frequency per Disclosure'' in table 1, row 1) for a total of 100 
labels that include the information set forth in section III.A.11 of 
the draft guidance (including directions for use) (``Total 
Disclosures'' in table 1, row 1). We also estimate that designing, 
testing, and producing each label will take approximately 0.5 hours for 
each repackaged drug product (``Hours per Disclosure'' in table 1, row 
1). The provision to add the statement http://www.fda.gov/medwatch and 
1-800-FDA-1088 is not included in this burden estimate because it is 
not considered a collection of information under the PRA because the 
information is ``originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).
    We also estimate that annually a total of approximately 10 
outsourcing facilities (``Number of Respondents'' in table 1, row 2) 
will each produce a copy of prescribing information as set forth in 
section III.A.11 of the draft guidance for approximately 10 repackaged 
drug products (``Frequency per Disclosure'' in table 1, row 1) for a 
total of 100 disclosures (``total disclosures'' in table 1, row 2). We 
also estimate that providing prescribing information labeling will take 
approximately 1 hour for each repackaged drug product (``Hours per 
Disclosure'' in table 1, row 2). The provision to add http://www.fda.gov/medwatch and 1-800-FDA-1088 is not included in this burden 
estimate because it is not considered a collection of information under 
the PRA because the information is ``originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the 
public'' (5 CFR 1320.3(c)(2)).
    The total estimated third-party disclosure burden resulting from 
the draft guidance is as follows:

                             Table 1--Estimated Annual Third-Party Disclosure Burden
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   Repackaging by outsourcing        Number of     Frequency per       Total         Hours per
           facilities               respondents     disclosure      disclosures     disclosure      Total hours
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Designing, testing, and                       10              10             100              .5              50
 producing each label on
 immediate containers, packages
 and/or outer containers........
Prescribing information labeling              10              10             100               1             100
 produced for each repackaged
 drug product...................
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    Total.......................  ..............  ..............  ..............  ..............             150
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There are no capital costs or operating and maintenance costs associated with this collection of information.
*(30 minutes)

    The draft guidance also references registration, product reporting, 
and CGMP requirements for outsourcing facilities. In the Federal 
Register of December 4, 2013 (78 FR 72899), FDA estimated the burden 
resulting from outsourcing facility registration. In the Federal 
Register of December 4, 2013 (78 FR 72897), FDA estimated the burden 
resulting from outsourcing facility interim product reporting. In the 
Federal Register of July 2, 2014 (79 FR 37743), FDA estimated the 
burden resulting from outsourcing facility compliance with CGMP 
requirements.

V. Electronic Access

    Persons with access to the Internet can obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03417 Filed 2-18-15; 8:45 am]
BILLING CODE 4164-01-P