Compounding and pharmacy
Is a compounding pharmacy allowed to make a custom version of a drug from research-grade material?
Plain English first, then the primary source. Education, not legal advice.
Interpretation
In short: compounding is a regulated activity with defined limits. It is not a general license to prepare unapproved substances.
Plain English
Sections 503A and 503B of the FD&C Act, codified at 21 U.S.C. 353a and 353b, create two distinct pathways for pharmacy and outsourcing facility compounding, each with its own conditions. Section 503A generally covers traditional pharmacy compounding for an identified individual patient based on a valid prescription, with exemptions from certain new drug and labeling requirements when specific conditions are met.
Section 503B allows registered outsourcing facilities to compound larger batches, including without patient-specific prescriptions in some cases, but requires compliance with current good manufacturing practice and other conditions, and compounded drugs must generally be made from bulk drug substances that meet specific sourcing standards, not from arbitrary research-grade material.
Compounding rules do not create a general path for turning an RUO chemical into a prescribable human drug. Sourcing requirements for bulk substances used in compounding are specific and limited.
Why it matters
- This directly addresses a recurring question about whether a licensed pharmacist can 'launder' an RUO compound into a legitimate prescription product simply by compounding it.
Where the answer becomes fact-specific
The Foundation does not manufacture legal conclusions. These points change the analysis and may require qualified regulatory counsel.
- Whether a bulk substance is eligible for use in compounding depends on FDA's bulk substance lists and other sourcing conditions specific to 503A or 503B.
View the source
- 21 U.S.C. 353a, pharmacy compounding, 21 U.S.C. § 353a
- 21 U.S.C. 353b, outsourcing facilities, 21 U.S.C. § 353b
- FDA, Compounding and FDA: Questions and Answers