November 4, 2022

A confusing proposed rule in Delaware

A proposed rule by the Delaware Board of Pharmacy has the potential to limit office stock compounding for veterinarians by 503A pharmacies. APC is submitting a comment letter and will be attending the board meeting on November 16.

Current Delaware regulation is confusing. It allows 503A pharmacies to compound office stock for veterinarians but is limited to 10 percent of the pharmacy’s total non-patient prescriptions. But it also requires compliance with federal law, meaning that Delaware-licensed 503A pharmacies are prohibited from compounding for vet office stock. Why? Because federal law (FDCA) allows only patient-specific compounding by 503A pharmacies.

The proposed rule authorizes 503B outsourcing facilities to compound for vet office stock and exempts them from the 10 percent cap, subject to federal law. The problem is that Section 503B of the law, like Section 503A, applies only to human drugs, not animal drugs (although some outsourcing facilities are now compounding animal drugs).

“GFI #256 reads as if written to apply to 503A state licensed pharmacies, and CVM has not announced any intention to exempt out outsourcing facilities from that process and the positive list of substances for office stock that it will establish,” said APC Director of Public Policy Savannah Cunningham.

“We are concerned that boards of pharmacy are being misinformed that FDA prefers outsourcing facilities over pharmacies for veterinary office stock or that GFI #256 does not apply to outsourcing facilities, and that some are changing their rules in ways that will limit or prohibit 503A pharmacies from compounding for vet office stock in those states. That’s why what happens in Delaware bears watching.”