80 FR 8872 - Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability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		8872-8874
FR Document		2015-03419

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for outsourcing facilities.

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

[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8872-8874]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-03419]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2138]

Adverse Event Reporting for Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Adverse Event Reporting for Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must
submit adverse event reports to FDA. This guidance explains FDA's
current thinking on adverse event reporting for outsourcing facilities.

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draft guidance before it begins work to finalize the guidance, submit
either electronic or written comments on this draft guidance by May 20,
2015. Submit either electronic or written comments concerning the
collection of information proposed in the draft guidance by May 20,
2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,

[[Page 8873]]

4th Floor, Silver Spring, MD 20993. Send one self-addressed adhesive
label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
Submit electronic comments on the draft 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: H. Joy Sharp, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Adverse Event Reporting for Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' On November
27, 2013, President Obama signed the Drug Quality and Security Act
(DQSA) into law (Pub. L. 113-54). The DQSA added a new section 503B to
the FD&C Act (21 U.S.C. 353b). Under section 503B(b), a compounder can
register as an outsourcing facility with FDA. Section 503B(d)(4) of the
FD&C Act defines an outsourcing facility, in part, as a facility that
complies with all of the requirements of section 503B, including
registering with FDA as an outsourcing facility and paying associated
fees. If the conditions outlined in section 503B(a) of the FD&C Act are
satisfied, a drug compounded by or under the direct supervision of a
licensed pharmacist in an outsourcing facility is exempt from certain
sections of the FD&C Act, including section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of drugs with adequate directions
for use) and section 505 (21 U.S.C. 355) (concerning the approval of
human drug products under new drug applications (NDAs) or abbreviated
new drug applications (ANDAs)). Drugs compounded in outsourcing
facilities are not exempt from the requirements of section 501(a)(2)(B)
of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice for drugs).
Under section 503B(b)(5), an outsourcing facility must submit
adverse event reports to FDA in accordance with the content and format
requirements established through guidance or regulation under section
310.305 of title 21, Code of Federal Regulations (or any successor
regulations). This draft guidance explains how FDA intends to implement
Sec. 310.305 with respect to outsourcing facilities.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
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. Paperwork Reduction Act

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
With respect to the collection of information associated with this
document, FDA invites comments on the following topics: (1) Whether the
proposed information collected is necessary for the proper performance
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimated burden of the
proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Under the draft guidance, registered outsourcing facilities must
submit to FDA adverse event reports within 15 calendar days of
receiving the information and must submit a followup report within 15
calendar days of receipt of new information about the adverse event, or
as requested by FDA. Outsourcing facilities must submit the adverse
event report using the existing Form FDA 3500A (which is approved by
OMB control number 0910-0291) or an alternate method in accordance with
Sec. 310.305(d). A copy of the current labeling of the compounded drug
product must be included. Each form should be submitted with a cover
letter that includes the following heading: ``Adverse event report
submitted by human drug compounding outsourcing facility (503B).''
Under Sec. 310.305, entities subject to the regulation must
maintain for 10 years the records of all adverse events required to be
reported under Sec. 310.305, including raw data and any correspondence
relating to the adverse event. The outsourcing facility should also
maintain records of its efforts to obtain the data elements described
in the draft guidance for each adverse event report.
The total estimated reporting and recordkeeping burdens for the
draft guidance are as follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of reporting Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
----------------------------------------------------------------------------------------------------------------
Submission of adverse event 50 2 100 1.1 110
reports including cover letter,
copy of labeling, and other
information as described in the
draft guidance.................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 110
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 8874]]

Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
Type of recordkeeping recordkeepers records per records recordkeeping Total hours
recordkeeper (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records of adverse events, including records of efforts to obtain 50 1 50 16 800
the data elements for each adverse event report...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

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
can 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. Electronic Access

Persons with access to the Internet may 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. 2015-03419 Filed 2-18-15; 8:45 am]
BILLING CODE 4164-01-P

8872 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices

Drug, and Cosmetic Act (the FD&C Act), 505 (21 U.S.C. 355) (concerning the comments may be seen in the Division
as added by the Drug Quality and approval of human drug products under of Dockets Management between 9 a.m.
Security Act (DQSA), of the regulatory new drug applications (NDAs) or and 4 p.m., Monday through Friday, and
implications of registration as an abbreviated new drug applications will be posted to the docket at http://
outsourcing facility. (ANDAs)). Drugs compounded in www.regulations.gov.
DATES: Although you can comment on outsourcing facilities are not exempt
from the requirements of section III. Electronic Access
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency 501(a)(2)(B) of the FD&C Act (21 U.S.C. Persons with access to the Internet
considers your comment on this draft 351(a)(2)(B)) (concerning current good may obtain the document at either
guidance before it begins work on the manufacturing practice for drugs). http://www.fda.gov/Drugs/Guidance
final version of the guidance, submit FDA has received questions about ComplianceRegulatoryInformation/
either electronic or written comments whether entities engaged in various Guidances/default.htm or http://
on the draft guidance by May 20, 2015. types of activities (e.g., a facility that is www.regulations.gov.
ADDRESSES: Submit written requests for
compounding only non-sterile drugs or Dated: February 11, 2015.
only repackaging biological products)
single copies of this guidance to the Leslie Kux,
should register as an outsourcing
Division of Drug Information, Center for Associate Commissioner for Policy.
facility. Because entities that register as
Drug Evaluation and Research, Food [FR Doc. 2015–03416 Filed 2–18–15; 8:45 am]
outsourcing facilities in fiscal year 2015
and Drug Administration, 10001 New
(beginning October 1, 2014) must pay a BILLING CODE 4164–01–P
Hampshire Ave., Hillandale Building,
registration fee and FDA has determined
4th Floor, Silver Spring, MD 20993.
that fees paid pursuant to sections 503B
Send one self-addressed adhesive label DEPARTMENT OF HEALTH AND
and 744K of the FD&C Act will not be
to assist that office in processing your HUMAN SERVICES
refunded, FDA is issuing this guidance
requests. See the SUPPLEMENTARY
to answer some of these questions and
INFORMATION section for electronic Food and Drug Administration
to provide potential registrants
access to the guidance document. additional information about the [Docket No. FDA–2014–D–2138]
Submit electronic comments on the
regulatory impact of registering as an
guidance to http://www.regulations.gov. Adverse Event Reporting for
outsourcing facility.
Submit written comments to the Elsewhere in this volume of the Outsourcing Facilities Under Section
Division of Dockets Management (HFA– Federal Register, FDA is announcing 503B of the Federal Food, Drug, and
305), Food and Drug Administration, the availability of separate FDA Cosmetic Act; Draft Guidance for
5630 Fishers Lane, Rm. 1061, Rockville, guidance documents on (1) mixing, Industry; Availability
MD 20852. diluting, or repackaging biological
FOR FURTHER INFORMATION CONTACT: Sara AGENCY: Food and Drug Administration,
products outside the scope of an
Rothman, Food and Drug HHS.
approved biologics license application,
Administration, 10903 New Hampshire and (2) repackaging certain human drug ACTION: Notice.
Ave., Silver Spring, MD 20993, 301– products by pharmacies and
796–3110. SUMMARY: The Food and Drug
outsourcing facilities. These guidance Administration (FDA or the Agency) is
SUPPLEMENTARY INFORMATION: documents describe FDA’s compliance announcing the availability of a draft
I. Background policies with respect to biological guidance for industry entitled ‘‘Adverse
products that are mixed, diluted, or Event Reporting for Outsourcing
FDA is announcing the availability of repackaged outside the scope of an
a draft guidance for industry entitled Facilities Under Section 503B of the
approved biologics license application Federal Food, Drug, and Cosmetic Act.’’
‘‘Guidance for Entities Considering and repackaged human drugs.
Whether to Register as Outsourcing Under the Federal Food, Drug, and
This draft guidance is being issued
Facilities Under Section 503B of the Cosmetic Act (the FD&C Act), an
consistent with FDA’s good guidance
Federal Food, Drug, and Cosmetic Act.’’ outsourcing facility must submit
practices regulation (21 CFR 10.115).
On November 27, 2013, President adverse event reports to FDA. This
The draft guidance, when finalized, will
Obama signed the DQSA (Pub. L. 113– guidance explains FDA’s current
represent the Agency’s current thinking
54) into law. The DQSA added a new thinking on adverse event reporting for
on registering as an outsourcing facility
section 503B to the FD&C Act that outsourcing facilities.
under section 503B of the FD&C Act. It
created a category of entities called does not create or confer any rights for DATES: Although you can comment on
‘‘outsourcing facilities.’’ Section or on any person and does not operate any guidance at any time (see 21 CFR
503B(d)(4) of the FD&C Act (21 U.S.C. to bind FDA or the public. An 10.115(g)(5)), to ensure that the Agency
353b(d)(4)) defines an outsourcing alternative approach may be used if considers your comment on this draft
facility, in part, as a facility that such approach satisfies the guidance before it begins work to
complies with all of the requirements of requirements of the applicable statutes finalize the guidance, submit either
section 503B, including registering with and regulations. electronic or written comments on this
FDA as an outsourcing facility and draft guidance by May 20, 2015. Submit
paying associated fees. If the conditions II. Comments either electronic or written comments
outlined in section 503B(a) of the FD&C Interested persons may submit either concerning the collection of information
emcdonald on DSK67QTVN1PROD with NOTICES

Act are satisfied, a drug compounded by electronic comments regarding this proposed in the draft guidance by May
or under the direct supervision of a document to http://www.regulations.gov 20, 2015.
licensed pharmacist in an outsourcing or written comments to the Division of ADDRESSES: Submit written requests for
facility is exempt from certain sections Dockets Management (see ADDRESSES). It single copies of the draft guidance to the
of the FD&C Act, including section is only necessary to send one set of Division of Drug Information, Center for
502(f)(1) (21 U.S.C. 352(f)(1)) comments. Identify comments with the Drug Evaluation and Research, Food
(concerning the labeling of drugs with docket number found in brackets in the and Drug Administration, 10001 New
adequate directions for use) and section heading of this document. Received Hampshire Ave., Hillandale Building,

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8874 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average bur-
Number of
Number of Total annual den per rec-
Type of recordkeeping records per Total hours
recordkeepers records ordkeeping
recordkeeper (hours)

Records of adverse events, including records of efforts to
obtain the data elements for each adverse event report 50 1 50 16 800
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments [insert State] and the U.S. Food and I. Background
Interested persons may submit either Drug Administration.’’ The draft Section 503A of the Federal Food,
electronic comments regarding this standard MOU describes the Drug, and Cosmetic Act (the FD&C Act)
document to http://www.regulations.gov responsibilities of the State that chooses (21 U.S.C. 353a) describes the
or written comments to the Division of to sign the MOU in investigating and conditions that must be satisfied for
Dockets Management (see ADDRESSES). It responding to complaints related to drug products compounded by a
is only necessary to send one set of compounded human drug products licensed pharmacist or licensed
comments. Identify comments with the distributed outside the State and in physician to be exempt from the
docket number found in brackets in the addressing the interstate distribution of following sections of the FD&C Act: (1)
heading of this document. Received inordinate amounts of compounded Section 501(a)(2)(B) (21 U.S.C.
comments can be seen in the Division human drug products. 351(a)(2)(B)) (concerning current good
FDA is also announcing the
of Dockets Management between 9 a.m. manufacturing practice (CGMP)
withdrawal of an earlier draft standard
and 4 p.m., Monday through Friday, and requirements), (2) section 502(f)(1) (21
MOU entitled ‘‘Memorandum of
will be posted to the docket at http:// U.S.C. 352(f)(1)) (concerning the
Understanding on Interstate Distribution
www.regulations.gov. labeling of drugs with adequate
of Compounded Drug Products,’’ which
directions for use), and (3) section 505
IV. Electronic Access was issued in January 1999. The January
1999 draft standard MOU is superseded (21 U.S.C. 355) (concerning the approval
Persons with access to the Internet of drugs under new drug applications or
may obtain the document at either by the new draft standard MOU.
abbreviated new drug applications).
http://www.fda.gov/Drugs/Guidance DATES: FDA is withdrawing its draft One of the conditions to qualify for
ComplianceRegulatoryInformation/ standard MOU that published on the exemptions listed in section 503A of
Guidances/default.htm or http:// January 21, 1999 (64 FR 3301), as of the FD&C Act is that (1) the drug
www.regulations.gov. February 19, 2015. Submit either product is compounded in a State that
electronic or written comments on the has entered into an MOU with FDA that
Dated: February 11, 2015.
new draft standard MOU by June 19, addresses the distribution of inordinate
Leslie Kux, 2015. Submit comments on information
Associate Commissioner for Policy. amounts of compounded drug products
collection issues under the Paperwork interstate and provides for appropriate
[FR Doc. 2015–03419 Filed 2–18–15; 8:45 am] Reduction Act of 1995 by June 19, 2015 investigation by a State agency of
BILLING CODE 4164–01–P (see the ‘‘Paperwork Reduction Act of
complaints relating to compounded
1995’’ section of this document).
drug products distributed outside such
ADDRESSES: Submit written requests for State; or (2) if the drug product is
DEPARTMENT OF HEALTH AND single copies of the MOU to Edisa
HUMAN SERVICES compounded in a State that has not
Gozun, Center for Drug Evaluation and entered into such an MOU, the licensed
Research, Food and Drug pharmacist, pharmacy, or physician
Food and Drug Administration Administration, 10903 New Hampshire does not distribute, or cause to be
[Docket No. FDA–2014–N–1459] Ave., Bldg. 51, Suite 5100, Silver distributed, compounded drug products
Spring, MD 20993–0002. Send one self- out of the State in which they are
Memorandum of Understanding addressed label to assist that office in
Addressing Certain Distributions of compounded in quantities that exceed 5
processing your request. See the percent of the total prescription orders
Compounded Human Drug Products SUPPLEMENTARY INFORMATION section for
Between the States and the Food and dispensed or distributed by such
electronic access to the new draft pharmacy or physician (see section
Drug Administration; New Proposed standard MOU.
Draft; Availability 503A(b)(3)(B)(i) and (b)(3)(B)(ii) of the
Submit electronic comments on the
FD&C Act).
new draft standard MOU or on the Section 503A(b)(3)(B) of the FD&C Act
AGENCY: Food and Drug Administration,
collection of information to http:// directs FDA to develop, in consultation
HHS.
www.regulations.gov. Submit written with the National Association of Boards
ACTION:Notice of availability; comments to the Division of Dockets
withdrawal. of Pharmacy (NABP), a standard MOU
Management (HFA–305), Food and Drug for use by the States in complying with
SUMMARY: The Food and Drug Administration, 5630 Fishers Lane, Rm. section 503A(b)(3)(B)(i).
1061, Rockville, MD 20852.
emcdonald on DSK67QTVN1PROD with NOTICES

Administration (FDA or the Agency) is
announcing the availability for public FOR FURTHER INFORMATION CONTACT: II. Previous Efforts To Develop a
comment of a draft standard Edisa Gozun, Center for Drug Evaluation Standard MOU
memorandum of understanding (MOU) and Research, Food and Drug In the Federal Register of January 21,
entitled ‘‘Memorandum of Administration, 10903 New Hampshire 1999 (64 FR 3301), FDA announced the
Understanding Addressing Certain Ave., Bldg. 51, Suite 5100, Silver availability for public comment of a
Distributions of Compounded Human Spring, MD 20993–0002, 301–796–3110. draft standard MOU, developed in
Drug Products Between the State of SUPPLEMENTARY INFORMATION: consultation with NABP (1999 draft

VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1

Document Created: 2018-02-16 11:12:44
Document Modified: 2018-02-16 11:12:44

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.
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 to finalize the guidance, submit either electronic or written comments on this draft guidance by May 20, 2015. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by May 20, 2015.
Contact		H. Joy Sharp, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100.
FR Citation		80 FR 8872

80 FR 8872 - Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; 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