2014-15372. Final Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; 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 guidance entitled “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The guidance announces the Agency's intention with regard to enforcement of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to regulate entities that compound drugs, now that the FD&C Act has been amended by the Drug Quality and Security Act (DQSA). The guidance reflects the Agency's current thinking on the issues addressed by the guidance.

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 Office of Communications, 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 request. 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:

Marissa Chaet Brykman, 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

FDA is announcing the availability of a guidance entitled “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The guidance provides information to compounders of human drug products on the Agency's application of section 503A of the FD&C Act (21 U.S.C. 353a) and current enforcement policies relating to the compounding of human drug products.

Section 503A of the FD&C Act describes the conditions that must be satisfied for drug products compounded by a licensed pharmacist or licensed physician to be exempt from the following three 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); (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). All other applicable provisions of the FD&C Act remain in effect for compounded drugs, however, even if the conditions in section 503A are met.

Previously, the conditions of section 503A of the FD&C Act also included restrictions on the advertising or promotion of the compounding of any particular drug, class of drug, or type of drug, and the solicitation of prescriptions for compounded drugs. These provisions were challenged in court and held unconstitutional by the U.S. Supreme Court in 2002.^[1] In 2013, the DQSA amended section 503A of the FD&C Act to remove the unconstitutional advertising, promotion, and solicitation provisions. As a result, it is necessary to explain FDA's current thinking with regard to section 503A of the FD&C Act. Several provisions of section 503A of the FD&C Act require rulemaking and consultation with a Pharmacy Compounding Advisory Committee to implement. In the guidance, FDA explains how those provisions will be applied pending those consultations and rulemaking.

Among other things, the guidance restates the provisions in section 503A of the FD&C Act that remain in effect, describes FDA's interim policies with respect to specific provisions in section 503A that require implementing regulations or other actions, and contains a non-exhaustive list of potential enforcement actions against individuals or firms that compound human drug products that do not meet the conditions of section 503A.

In the Federal Register of December 4, 2013 (78 FR 72901), FDA issued a document announcing the availability of the draft version of this guidance and the withdrawal of both the May 2002 Compliance Policy Guide entitled “Pharmacy Compounding” and the November 1998 guidance for industry entitled “Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act.” The comment period on the draft guidance ended on February 3, 2014. Many of the received comments raise issues that the Agency intends to address in other policy documents and were not directly pertinent to the topics addressed in this guidance. These comments will be further considered if relevant to another policy document developed by the Agency.

FDA made the following changes in the final guidance: (1) Inserted references to the Federal Register documents seeking nominations for the bulk drug substances and difficult-to-compound lists under section 503A (78 FR 72841, December 4, 2013, and 78 FR 72840, December 4, 2013, respectively); (2) modified the language that discusses the time period during which the MOU will be made available to the States for their consideration and signature and the time period with regard to the enforcement of the 5 percent limit if a State chooses not to sign the MOU; and (3) made grammatical and other minor editorial changes for clarity.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking regarding section 503A of the FD&C Act and human drug compounding. 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/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.

Dated: June 25, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

Footnotes

1.  See Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002).