SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” In 2013, the Drug Quality and Security Act, created new section 503B of the FD&C Act (21 U.S.C. 353b), which describes a new category of compounders called outsourcing facilities. Section 503B of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from the following three sections of the FD&C Act:

• Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning labeling of drugs with adequate directions for use); ( printed page 2787)
• Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); and
• Section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements).

One of the conditions that must be met for a compounded drug product to qualify for the exemptions under section 503B of the FD&C Act is that the drug is not essentially a copy of one or more approved drugs (section 503B(a)(5)).

Section 503B(d)(2) defines essentially a copy of an approved drug as:

• A drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 503(b) and not subject to approval in an application submitted under section 505, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing (section 503B(d)(2)(A)) or
• a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug that is not subject to section 503(b) and not subject to approval in an application submitted under section 505, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug (section 503B(d)(2)(B)).

This guidance sets forth FDA's policies concerning the “essentially a copy” provision of section 503B of the FD&C Act.

In the Federal Register of July 11, 2016 (81 FR 44879), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on October 11, 2016. FDA received 29 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes. For example, in response to requests in comments for direction on records retention, FDA added a recommendation that compounders maintain the records described in the guidance for at least 3 years. In addition, to address questions raised in comments, FDA clarified that the Agency does not intend to take action against an outsourcing facility for failing to compound in accordance with section 503B(a)(5) if it fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.

FDA received comments from hospital organizations regarding the potential implications of proposed policies for the preparation of compounded drugs used in in-patient settings. The final guidance notes that FDA is considering the applicability of the policies described in this guidance to hospitals and health systems. We recognize that this issue is of interest to many stakeholders and will publicly convey our further thinking on the applicability of these policies to hospitals and health systems with an opportunity for comment.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

This guidance contains collections of information that are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 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 concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of July 11, 2016, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance.

The information collection provisions in this guidance have been submitted to OMB for review as required by section 3507(d) of the PRA. These provisions are not in effect until they display a currently valid OMB control number. FDA will publish a notice in the Federal Register announcing OMB's decision regarding the information collection provisions in this guidance.

III. Electronic Access

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or https://www.regulations.gov.