Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Draft Guidance for Industry; Availability, 8884-8886 [2015-03417]
Download as PDF
<![CDATA[
8884
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Biological product mixing, diluting, and repackaging
Frequency per
disclosure
Total
disclosures
Hours per
disclosure
Total hours
Designing, testing, and producing the label, container,
packages, and/or outer containers for each mixed, diluted, or repackaged biological product .........................
Prescribing information labeling accompanying each
mixed, diluted, or repackaged drug product ..................
5
5
25
0.5
5
5
25
1
Total ............................................................................
........................
........................
........................
........................
12.5
25
37.5
1 There
*(30
are no capital costs or operating and maintenance costs associated with this collection of information.
minutes)
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Preparation of prescription sets
Frequency per
disclosure
Total
disclosures
Hours per
disclosure
Total hours
Designing, testing, and producing each label on immediate containers, packages, and/or outer containers .....
Including instructions for use labeling and the original
package insert(s) for each prescription set ....................
5
300
1500
0.5
750
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The draft guidance also references
registration, product reporting, current
good manufacturing practice (CGMP)
requirements, and the payment of
certain fees by human drug
compounding 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 April 1, 2014 (79 FR
18297), FDA estimated the burden
resulting from the payment of certain
fees by outsourcing facilities. In the
Federal Register of July 2, 2014 (79 FR
37743), FDA estimated the burden
resulting from outsourcing facility
compliance with CGMP requirements.
emcdonald on DSK67QTVN1PROD with NOTICES
IV. Electronic Access
Persons with access to the Internet
can obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm or https://
www.regulations.gov.
Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–03418 Filed 2–18–15; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:58 Feb 18, 2015
Jkt 235001
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.
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
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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 https://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
E:\FR\FM\19FEN1.SGM
19FEN1
emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices
‘‘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 patientspecific prescription or order for that
patient; or repackaging a solid oral
dosage form drug product by a statelicensed 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
VerDate Sep<11>2014
16:58 Feb 18, 2015
Jkt 235001
‘‘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 https://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 https://
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
8885
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.
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
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
• 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 FDAapproved 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
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 https://
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:
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: https://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 https://
www.fda.gov/medwatch and 1–800–
FDA–1088 is not included in this
burden estimate because it is not
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of
respondents
Repackaging by outsourcing facilities
Frequency per
disclosure
Total
disclosures
Hours per
disclosure
Total hours
Designing, testing, and producing each label on immediate
containers, packages and/or outer containers .................
Prescribing information labeling produced for each repackaged drug product ............................................................
10
10
100
.5
50
10
10
100
1
100
Total ..............................................................................
........................
........................
........................
........................
150
emcdonald on DSK67QTVN1PROD with NOTICES
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 https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Health Information
National Trends Survey (HINTS) (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
SUMMARY:
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
]]>Agencies
[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8884-8886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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 https://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 https://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 https://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: https://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 https://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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
