FDA Releases Guidance for Compounded Drug Products under Section 503B

07/07/2016

FDA Releases Guidance for Compounded Drug Products under Section 503B

This FDA draft guidance, ‘Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act’, offers recommendations to outsourcing facilities performing drug compounding on the best practices and correct procedures for compounding drugs for patients as an alternative to commercially available drug products.

Compounding is often performed to replicate commercially available drugs in instances such as when the commercial version, contains a non-active allergen ingredient, is in a form which is undeliverable for the patient, or is required in dosage not available in the commercially available form.  Compounding may also be performed when the commercial drug is not available, it might no longer be produced or it might be listed on the FDA shortage list.

The guidance highlights that outsourcing facilities, which can be used for compounding, will be subject to FDA inspections and must maintain the same high levels they require for compounding for all other drug compounding, not just those being done under exemption.

It also states that the outsourcing facility will not know the identity of the individual the compounding is being performed for, they should obtain a statement from the practitioner detailing how and why the drug differs from a commercially available option, and is not therefore essentially a copy.

Recommendations are also given for procedures to follow during the process, including checks that should be made before compounding is performed, in lieu of commercially available drugs, and the correct way to document the process to help ensure conformity to procedure.

Full guidance is available here.

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