Transcript Document

The FDA and
Animal Drug
Compounding
Neal Bataller, DVM
FDA/Center for Veterinary Medicine
AAVPT 14th Biennial Symposium, May 16-17, 2005, Rockville, MD
Pg. 267-279 (Slide#1-13)
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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: [email protected]
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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
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Compounding Permitted Under 21 CFR 530
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Law and regulation do NOT apply to bulk drugs
(Active Pharmaceutical Ingredients – APIs)
Legally compounded drugs:
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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.
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Compounding Permitted Under 21 CFR 530
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Legal compounding of drugs:
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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
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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
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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
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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
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General Concerns with Compounding
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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
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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)
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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:
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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
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Import Alert #68-09
“Bulk New Animal Drug Substances”
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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.
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Division of Compliance – (240) 276-9200
Neal Bataller – (240) 276-9202
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