80 FR 8884 - Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 33 (February 19, 2015)

Page Range		8884-8886
FR Document		2015-03417

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.''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.

Federal Register, Volume 80 Issue 33 (Thursday, February 19, 2015)

[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8884-8886]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-03417]

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

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Outsourcing Facilities; Draft Guidance for Industry; Availability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.

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

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announcing the availability of a draft guidance for industry entitled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:
The statement ``This drug product was repackaged by [name
of outsourcing facility].''
The address and phone number of the outsourcing facility
that repackaged the drug product.
The established name of the original, approved drug
product that was repackaged.
The lot or batch number of the repackaged drug product.
The dosage form and strength of the repackaged drug
product.

[[Page 8886]]

A statement of either the quantity or volume of the
repackaged drug product, whichever is appropriate.
The date the drug product was repackaged.
The beyond-use-date of the repackaged drug product.
Storage and handling instructions for the repackaged drug
product.
The National Drug Code (NDC) number of the repackaged drug
product, if available.\1\
---------------------------------------------------------------------------

\1\ The NDC number of the original approved drug product should
not be placed on the repackaged drug product.
---------------------------------------------------------------------------

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.''
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
----------------------------------------------------------------------------------------------------------------
Repackaging by outsourcing Number of Frequency per Total Hours per
facilities respondents disclosure disclosures disclosure Total hours
----------------------------------------------------------------------------------------------------------------
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...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 150
----------------------------------------------------------------------------------------------------------------
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

8884 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Frequency per Total Hours per
Biological product mixing, diluting, and repackaging Total hours
respondents disclosure disclosures disclosure

Designing, testing, and producing the label, container,
packages, and/or outer containers for each mixed, di-
luted, or repackaged biological product ......................... 5 5 25 0.5 12.5
Prescribing information labeling accompanying each
mixed, diluted, or repackaged drug product .................. 5 5 25 1 25

Total ............................................................................ ........................ ........................ ........................ ........................ 37.5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
*(30 minutes)

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Frequency per Total Hours per
Preparation of prescription sets Total hours
respondents disclosure disclosures disclosure

Designing, testing, and producing each label on imme-
diate containers, packages, and/or outer containers ..... 5 300 1500 0.5 750
Including instructions for use labeling and the original
package insert(s) for each prescription set .................... 5 300 1500 1 1500

Total ............................................................................ ........................ ........................ ........................ ........................ 2250
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
*(30 minutes)

The draft guidance also references DEPARTMENT OF HEALTH AND CPG Manual, entitled ‘‘Hospital
registration, product reporting, current HUMAN SERVICES Pharmacies—Status as Drug
good manufacturing practice (CGMP) Manufacturer,’’ which was issued in
requirements, and the payment of Food and Drug Administration October 1980.
certain fees by human drug [Docket No. FDA–2014–D–1524] DATES: Although you can comment on
compounding outsourcing facilities. In any guidance at any time (see 21 CFR
the Federal Register of December 4, Repackaging of Certain Human Drug 10.115(g)(5)), to ensure that the Agency
2013 (78 FR 72899), FDA estimated the Products by Pharmacies and considers your comment on this draft
burden resulting from outsourcing Outsourcing Facilities; Draft Guidance guidance before it begins work on the
facility registration. In the Federal for Industry; Availability final version of the guidance, submit
Register of December 4, 2013 (78 FR either electronic or written comments
AGENCY: Food and Drug Administration,
72897), FDA estimated the burden on the draft guidance by May 20, 2015.
HHS.
resulting from outsourcing facility ADDRESSES: Submit written requests for
ACTION: Notice of availability.
interim product reporting. In the single copies of this guidance to the
Federal Register of April 1, 2014 (79 FR SUMMARY: The Food and Drug Division of Drug Information, Center for
18297), FDA estimated the burden Administration (FDA or the Agency) is Drug Evaluation and Research, Food
resulting from the payment of certain announcing the availability of a draft and Drug Administration, 10903 New
fees by outsourcing facilities. In the guidance for industry entitled Hampshire Ave., Bldg. 51, Rm. 2201,
Federal Register of July 2, 2014 (79 FR ‘‘Repackaging of Certain Human Drug Silver Spring, MD 20993–0002. Send
37743), FDA estimated the burden Products by Pharmacies and one self-addressed adhesive label to
resulting from outsourcing facility Outsourcing Facilities.’’ This guidance assist that office in processing your
compliance with CGMP requirements. describes the conditions under which requests. See the SUPPLEMENTARY
FDA does not intend to take action for INFORMATION section for electronic
IV. Electronic Access violations of the Federal Food, Drug, access to the guidance document.
and Cosmetic Act (the FD&C Act), when Submit electronic comments on the
Persons with access to the Internet a state-licensed pharmacy, a Federal guidance to http://www.regulations.gov.
can obtain the document at either facility, or an outsourcing facility Submit written comments to the
http://www.fda.gov/Drugs/Guidance repackages human drug products. Division of Dockets Management (HFA–
ComplianceRegulatoryInformation/ When this guidance becomes final, 305), Food and Drug Administration,
Guidances/default.htm, http:// the Agency may also consider 5630 Fishers Lane, Rm. 1061, Rockville,
www.fda.gov/BiologicsBloodVaccines/ withdrawing or revising other guidance MD 20852.
GuidanceComplianceRegulatory documents that address human drug FOR FURTHER INFORMATION CONTACT: Gail
emcdonald on DSK67QTVN1PROD with NOTICES

Information/default.htm or http:// repackaging, including section 446.100 Bormel, Food and Drug Administration,
www.regulations.gov. of the Compliance Program Guidance 10001 New Hampshire Ave., Silver
Dated: February 11, 2015. (CPG) Manual, entitled ‘‘Regulatory Spring, MD 20903, 301–796–3110.
Action Regarding Approved New Drugs SUPPLEMENTARY INFORMATION:
Leslie Kux,
and Antibiotic Drug Products Subjected
Associate Commissioner for Policy. to Additional Processing or other I. Announcement of Draft Guidance
[FR Doc. 2015–03418 Filed 2–18–15; 8:45 am] Manipulations,’’ which was issued in FDA is announcing the availability of
BILLING CODE 4164–01–P January 1991, and section 460.100 of the a draft guidance for industry entitled

VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1

Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 8885

‘‘Repackaging of Certain Human Drug ‘‘Mixing, Diluting, or Repackaging of U.S.C. 3501–3520). The title,
Products by Pharmacies and Biological Products Outside the Scope description, and respondent description
Outsourcing Facilities.’’ FDA regards of an Approved Biologics License of the information collection are given
repackaging as the act of taking a Application.’’ When these two under this section with an estimate of
finished drug product from the guidances become final, they will the annual reporting and recordkeeping
container in which it was distributed by address and clarify the Agency’s policy burdens. Included in the estimate is the
the original manufacturer and placing it regarding hospital pharmacies time for reviewing instructions,
into a different container without repackaging and safely transferring searching existing data sources,
further manipulation of the drug. If a repackaged drugs to other hospitals gathering and maintaining the data
drug is manipulated in any other way, within the same health system during a needed, and completing and reviewing
including if the drug is reconstituted, drug shortage. Therefore, under section the collection of information.
diluted, mixed, or combined with 506F(d) of the FD&C Act, when FDA We invite comments on these topics:
another ingredient, that act is not issues these as final guidances, section (1) Whether the proposed collection of
considered repackaging. 506F will no longer apply. information is necessary for the proper
Repackaged drugs are generally not This draft guidance is being issued performance of FDA’s functions,
exempt from any of the provisions of the consistent with FDA’s good guidance including whether the information will
FD&C Act related to the production of practices regulation (21 CFR 10.115). have practical utility; (2) the accuracy of
drugs. For example, repackaged drugs This guidance, when finalized, will FDA’s estimate of the burden of the
are generally subject to the premarket represent FDA’s current thinking on proposed collection of information,
approval, misbranding, and adulteration repackaging human drug products by including the validity of the
provisions of the FD&C Act, including pharmacies, Federal facilities, and methodology and assumptions used; (3)
section 505 (concerning new drug outsourcing facilities. It does not create ways to enhance the quality, utility, and
applications), section 502(f)(1) or confer any rights for or on any person clarity of the information to be
(concerning labeling with adequate and does not operate to bind FDA or the collected; and (4) ways to minimize the
directions for use), and section public. An alternative approach may be burden of the collection of information
501(a)(2)(B) (concerning current good used if such approach satisfies the on respondents, including through the
manufacturing practice (CGMP) (21 requirements of the applicable statutes use of automated collection techniques,
U.S.C. 355, 352(f)(1), and 351(a)(2)(B) of and regulations. when appropriate, and other forms of
the FD&C Act). information technology.
Further, drugs that are repackaged are II. Amendment or Withdrawal of
Repackaging Guidance Documents Title: Repackaging of Certain Human
not subject to sections 503A and 503B
Drug Products by Pharmacies and
of the FD&C Act (21 U.S.C. 353a and When this guidance becomes final,
Outsourcing Facilities; Guidance for
353b). Therefore, drugs repackaged by the Agency may also consider
Industry.
state-licensed pharmacies, Federal withdrawing or revising other guidance
facilities, or outsourcing facilities are Description: The draft guidance
documents that address human drug
not eligible for the exemptions provided describes repackaging by state-licensed
repackaging. These may include section
under those sections. pharmacies, Federal facilities, and
446.100 of the CPG Manual, entitled
This draft guidance describes the outsourcing facilities under section
‘‘Regulatory Action Regarding Approved
conditions under which FDA does not 503B of the FD&C Act, and it describes
New Drugs and Antibiotic Drug
intend to take action for violations of the conditions under which FDA does
Products Subjected to Additional
sections 505, 502(f)(1), and, where not intend to take action for violations
Processing or other Manipulations,’’
specified in the guidance, section of sections 505, 502(f)(1), and where
which was issued in January 1991, and
501(a)(2)(B) of the FD&C Act, when a specified, section 501(a)(2)(B) of the
section 460.100 of the CPG Manual,
state-licensed pharmacy, Federal FD&C Act, when a state-licensed
entitled ‘‘Hospital Pharmacies—Status
facility, or registered outsourcing pharmacy, or Federal facility, or an
as Drug Manufacturer,’’ which was
facility repackages drug products. The outsourcing facility repackages drug
issued in October 1980.
guidance does not address repackaging products. The draft guidance includes
of nonprescription drugs; drugs that are III. Comments the following collection of information
intended for use in animals; biological Interested persons may submit either under the PRA:
products subject to licensure under electronic comments regarding this One condition in the draft guidance is
section 351 of the Public Health document to http://www.regulations.gov that if a drug is repackaged by an
Services Act (42 U.S.C. 262); or written comments to the Division of outsourcing facility, the label on the
repackaging by entities that are not Dockets Management (see ADDRESSES). It immediate container (primary
state-licensed pharmacies, Federal is only necessary to send one set of packaging, e.g., the syringe) of the
facilities, or registered outsourcing comments. Identify comments with the repackaged product includes the
facilities; removing a drug product from docket number found in brackets in the following information:
the original container at the point of heading of this document. Received • The statement ‘‘This drug product
care for immediate administration to a comments may be seen in the Division was repackaged by [name of outsourcing
single patient after receipt of a patient- of Dockets Management between 9 a.m. facility].’’
specific prescription or order for that and 4 p.m., Monday through Friday, and • The address and phone number of
patient; or repackaging a solid oral will be posted to the docket at http:// the outsourcing facility that repackaged
emcdonald on DSK67QTVN1PROD with NOTICES

dosage form drug product by a state- www.regulations.gov. the drug product.
licensed pharmacy for purposes of • The established name of the
dispensing the drug to a patient upon IV. Paperwork Reduction Act of 1995 original, approved drug product that
receipt of an individual patient-specific This draft guidance contains was repackaged.
prescription. information collection provisions that • The lot or batch number of the
Elsewhere in this issue of the Federal are subject to review by the Office of repackaged drug product.
Register, the Agency is making available Management and Budget under the • The dosage form and strength of the
for comment a draft guidance entitled Paperwork Reduction Act of 1995 (44 repackaged drug product.

VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1

8886 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices

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

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of Frequency per Total Hours per
Repackaging by outsourcing facilities Total hours
respondents disclosure disclosures disclosure

Designing, testing, and producing each label on immediate
containers, packages and/or outer containers ................. 10 10 100 .5 50
Prescribing information labeling produced for each repack-
aged drug product ............................................................ 10 10 100 1 100

Total .............................................................................. ........................ ........................ ........................ ........................ 150
There are no capital costs or operating and maintenance costs associated with this collection of information.
*(30 minutes)

The draft guidance also references V. Electronic Access DEPARTMENT OF HEALTH AND
registration, product reporting, and HUMAN SERVICES
CGMP requirements for outsourcing Persons with access to the Internet
facilities. In the Federal Register of can obtain the document at either http:// National Institutes of Health
December 4, 2013 (78 FR 72899), FDA www.fda.gov/Drugs/Guidance
estimated the burden resulting from ComplianceRegulatoryInformation/ Submission for OMB Review; 30-Day
outsourcing facility registration. In the Guidances/default.htm or http:// Comment Request; Health Information
Federal Register of December 4, 2013 www.regulations.gov. National Trends Survey (HINTS) (NCI)
(78 FR 72897), FDA estimated the Dated: February 11, 2015.
SUMMARY: Under the provisions of
burden resulting from outsourcing Leslie Kux,
Section 3507(a)(1)(D) of the Paperwork
facility interim product reporting. In the Associate Commissioner for Policy. Reduction Act of 1995, the National
emcdonald on DSK67QTVN1PROD with NOTICES

Federal Register of July 2, 2014 (79 FR [FR Doc. 2015–03417 Filed 2–18–15; 8:45 am] Institutes of Health (NIH), has submitted
37743), FDA estimated the burden
BILLING CODE 4164–01–P to the Office of Management and Budget
resulting from outsourcing facility
(OMB) a request for review and
compliance with CGMP requirements.
approval of the information collection

1 The NDC number of the original approved drug

product should not be placed on the repackaged
drug product.

VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1

Document Created: 2018-02-16 11:12:41
Document Modified: 2018-02-16 11:12:41

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
Contact		Gail Bormel, Food and Drug Administration, 10001 New Hampshire Ave., Silver Spring, MD 20903, 301- 796-3110.
FR Citation		80 FR 8884

80 FR 8884 - Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 33 (February 19, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration