Sections 503A and 503B contain various requirements for FDA to develop
lists of drugs that may or may not be compounded and lists of bulk drug
substances that may be used to compound. Specifically, section 503A specifies
that to qualify for the exemptions under section 503A, a compounder may only use
bulk drug substances to compound if:
The bulk drug substances comply with the standards of an applicable United
States Pharmacopoeia (USP) or National Formulary (NF) monograph, if one exists;
- If such a monograph does not exist, the drug substance(s) is a component of an FDA-approved human drug product; or
- If such a monograph does not exist and the drug substance is not a component of an FDA-approved human drug product, it appears on a list of bulk drug substances for use in compounding developed by FDA through regulation (section 503A(b)(1)(A)(i) of the FDCA).
Section 503B specifies that an outsourcing facility may only compound with
a bulk drug substance which appears on an FDA-established list of bulk drug
substances for which there is a clinical need or which are on FDA’s drug
shortage list.
Sections 503A and 503B also prohibit compounding drugs that are on a list
of drugs that present demonstrable difficulties for compounding, as published by
FDA.
FDA has published notices3
requesting nominations for these three lists.
In addition, 21 CFR 216.24 contains a list of drugs that may not be
compounded because they have been withdrawn or removed from the market because
the drugs or components of the drugs have been found to be unsafe or not
effective. Compounders may not compound any drugs that appear on this list. FDA
intends to issue a proposed rule to update this list by amending section 216.24
and will apply the list to compounders seeking to qualify for the exemptions in
either section 503A or section 503B. Nominations for this list can be submitted
in comments on the proposed rule.
quoted from FDA website
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