Virginia pharmacists would follow safety rules for compounded medicines

Pharmacists may use bulk drug substances to make compounded medicines. These conditions apply when pharmacists use bulk drug substances in compounding. The substance must meet at least one listed drug-standard or FDA qualification, be pharmaceutical grade, and come with a certificate of analysis. The pharmacist must document a qualifying FDA inspection of the manufacturer within the past two years and conduct or obtain quality testing. A different supplier may be used if the Board and FDA approve it and the pharmacist can show purity and safety by reasonable means.

Pharmacists may not regularly compound, or compound excessive amounts of, human medicines that are essentially copies of available commercial drugs. The restriction covers human medicines that copy an FDA-approved drug not listed as discontinued. Exceptions include a patient-specific change that makes a clinically significant difference, a drug shortage or unavailability, an urgent need, or mixing two or more available products. For a patient-specific clinical difference, the prescriber must document a medical reason other than cost or convenience and explain how the compounded medicine would address it. A prefilled form or automated note is not enough.

Pharmacists may not compound a human medicine containing a bulk substance that the FDA withdrew for safety or that is covered by an effective, unapproved investigational drug application. This restriction applies to compounding for human use. The restriction for an FDA-withdrawn drug applies only to the scope of the FDA withdrawal for safety or effectiveness.

Pharmacists must keep compounding records and provide them for Board inspection or audit. These requirements cover pharmacists and pharmacies that compound medicines. Records for medicines made in batches or with bulk ingredients must include added details about ingredients, lots, quantities, beyond-use dates, and quality testing. Pharmacies must keep a full formula when needed to repeat a complex preparation and a written quality plan with records of staff training, equipment checks, environmental monitoring, and applicable testing. Requested records must be available within 48 hours, or within another reasonable time the Board sets based on the request.