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Please note that this is a FINALIZED document and represents the current thinking of the FDA.
IMPORTANT: OBTAIN A COPY FROM THE ABOVE WEBSITE AND READ IT IN ITS ENTIRETY. BELOW IS ONLY A SUMMARY.
Background
One of the conditions that must be met for a compounded drug product to qualify for exemptions is that a licensed pharmacist or licensed physician compounds the drug product using bulk drug substances that:
- Comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding;
- If such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or
- 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.
A bulk drug substance is defined as meaning "the same as active pharmaceutical ingredient as defined in 21 CFR 207.1(b)."
An active pharmaceutical ingredient is defined as "any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body."
- An applicable USP or NF monograph means an official USP or NF drug substance monograph.
- FDA does not consider USP monographs for dietary supplements to be "applicable" USP or NF monographs.
Bulk drug substances must also meet certain other requirements including:
- It must be manufactured by a registered establishment.
- It must be accompanied by a valid certificate of analysis (COA).
Policy
A bulk drug substance that is not the subject of an applicable USP or NF monograph or is not a component of an FDA-approved drug cannot be used in compounding unless it appears on a list promulgated as a regulation pursuant to the FD&C Act.
Until a substance has been evaluated and is identified in a final rule as being included or not included on the 503A bulks list, FDA does not intend to take action provided that the following conditions are met:
- The bulk drug substance appears in 503A Category 1 on FDA's website at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/PharmacyCompounding/UCM467373.pdf.
A Category 1 substance
- may be eligible for inclusion on the 503A bulks list,
- was nominated with sufficient supporting information for the FDA to evaluate it, and
- has not been identified by the FDA as a substance that presents a significant safety risk in compounding prior to the publication of a final rule.
- The original manufacturer and all subsequent manufacturers of the bulk drug substance are establishments that are registered;
- The bulk drug substance is accompanied by a valid COA; and
- The drug product compounded using the bulk drug substance is compounded in compliance with all other conditions of section 503A of the FD&C Act.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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