1 The FDA and Animal Drug Compounding Neal Bataller, DVM FDA/Center for Veterinary Medicine AAVPT 14 th Biennial Symposium, May 16-17, 2005, Rockville, MD Pg (Slide#1-13)

2 Neal Bataller, DVM Veterinary Medical Officer Division of Compliance Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place Rockville, MD Telephone: (240)

3 FDA Laws and Regulations Food, Drug, and Cosmetic Act Protect the consumer by safeguarding the food supply Ensure safe and effective animal drugs Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) – 21 CFR Allows veterinarians to prescribe extralabel uses of certain APPROVED animal drugs and APPROVED human drugs for animals, under certain conditions

4 Compounding Permitted Under 21 CFR 530 Law and regulation do NOT apply to bulk drugs (Active Pharmaceutical Ingredients – APIs) Legally compounded drugs: Must utilize only FDA-approved human / animal drugs. Are permissible only if no approved human / animal drug will treat the condition. (For food animals) Can use approved human drug(s) only if no approved animal drug will meet the medical need.

5 Compounding Permitted Under 21 CFR 530 Legal compounding of drugs: Can be done only by licensed pharmacists or vets within the scope of professional practice Requires that procedures / processes are in place to ensure product safety / effectiveness Is done at a scale of operation proportional to the need Requires that all relevant state laws are followed Guidance is elsewhere available

6 FDA Policy FDA Compliance Policy Guide (CPG), Section : “Compounding of Drugs for Use in Animals” Identifies types of compounding that may be subject to enforcement action. Describes factors the FDA will consider in exercising its regulatory discretion. Reflects the FDA’s current enforcement priorities –subject to change, not binding. Issued July, 1996; revised July, 2003

7 CPG Compounding Concerns Health of the animal is not threatened Compounding takes place in anticipation of receiving RX Drugs used are prohibited from extralabel use Bulk drugs (APIs) are used (with some exceptions – listed poison antidotes) Restricted human drugs are used (e.g., thalidomide, clozapine, dofetilide, mifepristone, and isotretinoin) Commercial scale production is employed

8 CPG Compounding Concerns Compounding done for third party who resells the products State laws are violated Approved products are available Human drugs are used when animal drugs are available Illegal residues are detected in food products Withdrawal time established by someone other than prescribing vet Insufficient labeling information / instructions for use

9 General Concerns with Compounding  Unknown quality control or manufacturing standards  Unknown assurance of purity, potency, or stability  Potential for unknown or unsafe residues  Potential animal safety and efficacy issues  Disincentive for FDA approval  Difficult to monitor – no reporting requirements

10 Recent Compounding Issues Motion to quash Inspection Warrant (July, 2003) FDA has jurisdiction to inspect compounding pharmacy CVM Assignment - Illegal Compounding of Veterinary Prescription Drugs (March, 2004) Write-in campaign addressing CPG (April, 2004) Seizure of animal drugs (August, 2004) Pharmacy suit against FDA (September, 2004) FDA illegally enforcing CPG Pharmacies be controlled by State Boards CVM to revise compounding CPG (September, 2004)

11 Animal Drug Compounding Assignment Sixteen of the twenty inspections have been completed Fewer than forty percent of the completed inspections considered for some form of regulatory action Five warning letters issued in late 2004 and 2005 Firms from the inspection assignment that were issued Warning Letters: Franck’s Lab, Ocala, Florida Lowlyn Pharmacies, Blanchard, Oklahoma Essential Pharmacy Compounding, Omaha, Nebraska Red River Pharmacy, Texarkana, Texas Veterinary Enterprises of Tomorrow, Mountain View, Oklahoma

12 Import Alert #68-09 “Bulk New Animal Drug Substances”  Detain importations of bulk new animal drug substances bearing indications for animal drug use, which are not consigned to individuals or firms holding approved NADA or INAD exemptions, or are not from approved suppliers as specified in the approved NADAs.

13 Division of Compliance – (240) Neal Bataller – (240)