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

Drug, and Cosmetic Act (the FD&C Act), 

as added by the Drug Quality and 

Security Act (DQSA), of the regulatory 

implications of registration as an 

outsourcing facility. 

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on the draft guidance by May 20, 2015.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, 10001 New 

Hampshire Ave., Hillandale Building, 

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 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: Sara 

Rothman, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–3110. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Guidance for Entities Considering 

Whether to Register as Outsourcing 

Facilities Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

On November 27, 2013, President 

Obama signed the DQSA (Pub. L. 113– 

54) into law. The DQSA added a new 

section 503B to the FD&C Act that 

created a category of entities called 

‘‘outsourcing facilities.’’ Section 

503B(d)(4) of the FD&C Act (21 U.S.C. 

353b(d)(4)) 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). 

FDA has received questions about 

whether entities engaged in various 

types of activities (e.g., a facility that is 

compounding only non-sterile drugs or 

only repackaging biological products) 

should register as an outsourcing 

facility. Because entities that register as 

outsourcing facilities in fiscal year 2015 

(beginning October 1, 2014) must pay a 

registration fee and FDA has determined 

that fees paid pursuant to sections 503B 

and 744K of the FD&C Act will not be 

refunded, FDA is issuing this guidance 

to answer some of these questions and 

to provide potential registrants 

additional information about the 

regulatory impact of registering as an 

outsourcing facility. 

Elsewhere in this volume of the 

Federal Register, FDA is announcing 

the availability of separate FDA 

guidance documents on (1) mixing, 

diluting, or repackaging biological 

products outside the scope of an 

approved biologics license application, 

and (2) repackaging certain human drug 

products by pharmacies and 

outsourcing facilities. These guidance 

documents describe FDA’s compliance 

policies with respect to biological 

products that are mixed, diluted, or 

repackaged outside the scope of an 

approved biologics license application 

and repackaged human drugs. 

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 registering as an outsourcing facility 

under section 503B of the FD&C Act. 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. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03416 Filed 2–18–15; 8:45 am] 

BILLING CODE 4164–01–P 

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, 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 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 § 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 

§ 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 § 310.305, entities subject to 

the regulation must maintain for 10 

years the records of all adverse events 

required to be reported under § 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

Type of reporting Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per response 

(hours) 

Total hours 

Submission of adverse event reports including cover letter, 

copy of labeling, and other information as described in 

the draft guidance ............................................................ 50 2 100 1.1 110 

Total .............................................................................. ........................ ........................ ........................ ........................ 110 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


emcdonald on DSK67QTVN1PROD with NOTICES
8874 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per recordkeeping 

(hours) 

Total hours 

Records of adverse events, including records of efforts to 

obtain the data elements for each adverse event report 50 1 50 16 800 

1There 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/Guidance

ComplianceRegulatoryInformation/

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1459] 

Memorandum of Understanding 

Addressing Certain Distributions of 

Compounded Human Drug Products 

Between the States and the Food and 

Drug Administration; New Proposed 

Draft; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; 

withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability for public 

comment of a draft standard 

memorandum of understanding (MOU) 

entitled ‘‘Memorandum of 

Understanding Addressing Certain 

Distributions of Compounded Human 

Drug Products Between the State of 

[insert State] and the U.S. Food and 

Drug Administration.’’ The draft 

standard MOU describes the 

responsibilities of the State that chooses 

to sign the MOU in investigating and 

responding to complaints related to 

compounded human drug products 

distributed outside the State and in 

addressing the interstate distribution of 

inordinate amounts of compounded 

human drug products. 

FDA is also announcing the 

withdrawal of an earlier draft standard 

MOU entitled ‘‘Memorandum of 

Understanding on Interstate Distribution 

of Compounded Drug Products,’’ which 

was issued in January 1999. The January 

1999 draft standard MOU is superseded 

by the new draft standard MOU. 

DATES: FDA is withdrawing its draft 

standard MOU that published on 

January 21, 1999 (64 FR 3301), as of 

February 19, 2015. Submit either 

electronic or written comments on the 

new draft standard MOU by June 19, 

2015. Submit comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 by June 19, 2015 

(see the ‘‘Paperwork Reduction Act of 

1995’’ section of this document). 

ADDRESSES: Submit written requests for 

single copies of the MOU to Edisa 

Gozun, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Suite 5100, Silver 

Spring, MD 20993–0002. Send one selfaddressed label to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the new draft 

standard MOU. 

Submit electronic comments on the 

new draft standard MOU or on the 

collection of information 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: 

Edisa Gozun, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Suite 5100, Silver 

Spring, MD 20993–0002, 301–796–3110. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 503A of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 353a) describes the 

conditions that must be satisfied for 

drug products compounded by a 

licensed pharmacist or licensed 

physician to be exempt from the 

following sections of the FD&C Act: (1) 

Section 501(a)(2)(B) (21 U.S.C. 

351(a)(2)(B)) (concerning current good 

manufacturing practice (CGMP) 

requirements), (2) section 502(f)(1) (21 

U.S.C. 352(f)(1)) (concerning the 

labeling of drugs with adequate 

directions for use), and (3) section 505 

(21 U.S.C. 355) (concerning the approval 

of drugs under new drug applications or 

abbreviated new drug applications). 

One of the conditions to qualify for 

the exemptions listed in section 503A of 

the FD&C Act is that (1) the drug 

product is compounded in a State that 

has entered into an MOU with FDA that 

addresses the distribution of inordinate 

amounts of compounded drug products 

interstate and provides for appropriate 

investigation by a State agency of 

complaints relating to compounded 

drug products distributed outside such 

State; or (2) if the drug product is 

compounded in a State that has not 

entered into such an MOU, the licensed 

pharmacist, pharmacy, or physician 

does not distribute, or cause to be 

distributed, compounded drug products 

out of the State in which they are 

compounded in quantities that exceed 5 

percent of the total prescription orders 

dispensed or distributed by such 

pharmacy or physician (see section 

503A(b)(3)(B)(i) and (b)(3)(B)(ii) of the 

FD&C Act). 

Section 503A(b)(3)(B) of the FD&C Act 

directs FDA to develop, in consultation 

with the National Association of Boards 

of Pharmacy (NABP), a standard MOU 

for use by the States in complying with 

section 503A(b)(3)(B)(i). 

II. Previous Efforts To Develop a 

Standard MOU 

In the Federal Register of January 21, 

1999 (64 FR 3301), FDA announced the 

availability for public comment of a 

draft standard MOU, developed in 

consultation with NABP (1999 draft 


emcdonald on DSK67QTVN1PROD with NOTICES