This week, the International Academy of Compounding Pharmacists (IACP) submitted formal comments to the Food & Drug Administration (FDA) regarding the Draft Guidance for Compounding Animal Drugs from Bulk Substances (GFI #230).
IACP’s Comments to FDA
Please click here to view the entire comments submitted to FDA regarding the GFI #230. To date, there have been 24 sets of comments sent to the FDA.
Why is GFI 230 a problem for compounders? “As proposed, the FDA’s Center for Veterinary Medicine (CVM) is attempting to circumvent the legislative process and, instead, create an entirely new approach to compounding,” says IACP Executive Vice President David Miller. “It’s not just that which concerns our membership and our Board, it’s that if left unopposed, these new policies could set a precedent to justify the FDA’s further efforts to regulate human compounding.”
For example, the GFI does away entirely with office-use for veterinarians and instead requires a patient-specific prescription for each and every compound. It applies language in federal human compounding statute to veterinary compounding without authorization from Congress and even gives human compounding registered 503B outsourcing facilities the ability to prepare veterinary compounds without authorization from Congress. Congress specifically provided for 503B outsourcing facilities to prepare sterile compounds for human use. FDA attempts to interfere with the traditional role of the states in defining what constitutes a valid prescription by requiring a series of specific statements on a ‘script before the pharmacist would be able to prepare and dispense the medication, potentially delaying prompt therapy for an animal in need.
“Additionally, for the first time ever, a health care practitioner – either a veterinarian or a pharmacist – would be required to report any and all adverse events to the FDA’s reporting system. Traditionally, doctors, pharmacists, nurses, and vets have participated in the voluntary MedWatch adverse event reporting program. If this goes into effect, how long before pharmacists will be required to report adverse events in compounded prescriptions for humans or, possibly, for any prescription they dispense?” explains Miller.
Thank You for Taking Action!
A big thank you to the more than 300 members who sent in their action alerts to your congressional representatives asking them to sign a letter to FDA to withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances. Your participation resulted in generating 20 congressional co-signers on the effort led by Congressmen Matt Salmon (R-AZ) and Kurt Schrader (D-OR).
The letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine. More importantly, the Congressmen point out that as written, the guidance attempts to create new regulatory authority without legislation to support that effort.
Please click here to view the final letter featuring 20 co-signers.