[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69856-69857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27692]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0329]


Fees for Human Drug Compounding Outsourcing Facilities Under the 
FD&C Act; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for industry entitled ``Fees for Human 
Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of 
the FD&C Act.'' The guidance is intended for entities that compound 
human drugs and elect to register as outsourcing facilities under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug 
Quality and Security Act (DQSA). Entities that elect to register as 
outsourcing facilities must pay certain fees to be considered 
outsourcing facilities. This guidance describes the annual 
establishment fee, the reinspection fee, annual adjustments to fees 
required by law, how to submit payment, the effect of failure to pay 
fees, and how to qualify as a small business to obtain a reduction of 
the annual establishment fee.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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: Jonathan Gil, Food and Drug 
Administration, 10001 New Hampshire Ave., Silver Spring, MD 20903, 301-
796-7900.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under 
Sections 503B and 744K of the FD&C 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 (21 U.S.C. 353B) that created 
a category of entities called ``outsourcing facilities.'' 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

[[Page 69857]]

good manufacturing practice for drugs). This guidance describes in 
detail the fee types and amounts an entity must pay to satisfy the fee 
requirements of sections 503B and 744K of the FD&C Act to be deemed an 
outsourcing facility and maintain its status as an outsourcing 
facility, the adjustments to the fees required by law, how to qualify 
as a small business to obtain a reduction of the annual establishment 
fee, how and when to submit payment to FDA, the effect of failure to 
pay fees, and fee-related dispute resolution.
    On April 1, 2014 (79 FR 18297), FDA announced the availability of 
the draft version of this guidance. The public comment period closed on 
June 2, 2014. One comment was received from the public, and FDA 
carefully considered that comment as it finalized the guidance. Some of 
the issues raised relate to matters that FDA intends to address in 
other policy documents and were not directly pertinent to the topics 
addressed in this guidance. During finalization of the guidance, FDA 
made both clarifying changes and minor editorial changes to the 
guidance and accompanying form. For example, FDA clarified that it 
intends to issue an invoice for reinspection fees within 14 calendar 
days of the close of the reinspection, and that the reinspection fee 
must be paid within 30 calendar days of the date of the invoice.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on fees associated with human drug compounding 
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. Comments

    Interested persons can 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.

III. Paperwork Reduction Act of 1995

    This guidance contains collections of information 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 collections of 
information have been approved under OMB control number 0910-0776.

IV. 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: November 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27692 Filed 11-21-14; 8:45 am]
BILLING CODE 4164-01-P