1

The FDA and Animal Drug

Compounding

Neal Bataller, DVMFDA/Center for Veterinary Medicine

AAVPT 14th Biennial Symposium, May 16-17, 2005, Rockville, MD

Pg. 267-279 (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 20855

Telephone: (240) 276-9202

E-mail: nbatalle@cvm.fda.gov

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 589.2000

• 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 608.400:

“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) 276-9200Neal Bataller – (240) 276-9202