Reed Smith Client Alerts

On March 24, the Food and Drug Administration (FDA or the Agency) announced its intention to exclude four bulk drug substances that were previously nominated by the compounding industry for inclusion on the 503B bulks list (bulks list). FDA also expressed its intent to approve one bulk drug substance to the bulks list in this announcement. FDA will accept comments on this announcement until May 24.

FDA’s announcement affects the following bulk drug substances:

To be excluded: (1) bromfenac sodium, (2) mitomycin-C, (3) nepafenac, and (4) hydroxychloroquine sulfate.

To be included: quinacrine hydrochloride (quinacrine).

Section 503B of the Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. section 353b) describes the conditions that must be satisfied for drug products compounded by an outsourcing facility to be exempt from section 505 (21 U.S.C. section 355) (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)); section 502(f)(1) (21 U.S.C. section 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and section 582 (21 U.S.C. section 360eee-1) (concerning drug supply chain security requirements).

One of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a drug using a bulk drug substance unless: (1) the bulk drug substance appears on a list established by the Secretary of Health and Human Services identifying bulk drug substances for which there is a clinical need (the 503B bulks list) or (2) the drug 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. section 356e) at the time of compounding, distribution, and dispensing.