FDA Releases Interim Policy for the Regulation of Bulk Drug Substances Used in Compounding

On October 26, 2015, FDA released two draft guidances with interim regulations regarding the use of bulk drug substances in compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Guidance Regarding Section 503A

Yesterday, FDA released the availability of a draft guidance entitled, “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This document, which was announced in the Federal Register today, was published with the intention of providing applicable parties with the Agency’s provisional regulatory policy concerning the use of bulk drug substances to compound human drug products. This will serve as the acting regulation while FDA works to complete the finalized list of bulk drug substances that can be used in compounding under the FD&C Act.

Section 503A of the FD&C Act describes the conditions which, if satisfied, allow certain compounded drug products to be exempt from the following three sections of the Act:

• Section 505 – concerning the approval of drugs under new drug applications or abbreviated new drug applications.
• Section 502(f)(1) – concerning the labeling of drugs with adequate directions for use.
• Section 501(a)(2)(B) – concerning current good manufacturing practice requirements.”

In the recent draft guidance, FDA proposes a condition that must be met by a compounded product in order to qualify for the exemptions listed above. The condition states that the licensed pharmacist or physician must compound the drug product using bulk drug substances that:

1. “Comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monographs, if a monograph exists, and the USP chapter on pharmacy compounding;
2. If such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or
3. If such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary under subsection (c) of section 503A.”

In addition, the Agency states that it will not take action against licensed pharmacists or physicians for the compounding a drug product:

• From a bulk drug substance that is not the subject of an applicable USP or NF monograph,
• That is not a component of an FDA-approved drug, or
• That does not appear on the list of bulk drug substances that can be used in compounding.

Guidance Regarding Section 503B

FDA also published a guidance entitled, “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” on the same day that the above mentioned draft guidance was released.

This draft guidance “describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the FD&C Act.”

According to section 503B, a human drug product that is compounded by an outsourcing facility must satisfy certain conditions in order to be exempt from sections 505, 502(f)(1), and 582 of the FD&C Act. The draft guidance states that outsourcing facility cannot compound drug products using a bulk drug substance unless:

1. “It appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need.
2. The drug product compounded from such bulk drug substances appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing.”

FDA also stated that it will not be taking action against an outsourcing facility for “the compounding a drug product from a bulk drug substance that does not appear on a list of bulk drug substances that may be used in compounding and is not used to compound a drug product that appears on the FDA drug shortage list at the time of compounding, distribution, and dispensing, while FDA develops the list of bulk drug substances that can be used in compounding.”

Until the final guidances are published, the policies listed in the draft guidance (outlined above) will act as FDA’s standing regulations for compounding activities involving bulk drug substances. For more details view the draft guidance regarding section 503A here, and 503B here.

Are you in the process of developing a compounded product that may be subject to the guidelines provided in the Agency’s recent draft guidance? We can help you achieve successful interactions with the Agency and get your product approved by the FDA. Contact us today to learn more about our services and how we can be of assistance to you.