Applying DQSA to Veterinary Medicine Will Cripple Access

Why Applying the Drug Quality and Security Act (DQSA) to Veterinary Medicine Will Cripple Access to Needed Medications for the Treatment of Animals

Veterinary drug compounding – the compounding of different drug products together or the creation of drug products from bulk chemical substances for administration to animals – is vital to the health, safety, and welfare of animals. Because there are so few commercially manufactured prescription drugs available for the cure, treatment, and prevention of diseases in animals, especially animals that are not used in food production, veterinarians and the pharmacists who work with them have been safely compounding animal drugs for decades.   
 
The Drug Quality and Security Act (“DQSA”) (enacted in late 2013) restructured federal law governing compounding for human drug preparations ... The DQSA’s statutory structure for human drug compounding would be wholly unworkable for veterinary compounding and jeopardize animal health ...   
 

“Office Use” of Veterinary Drugs is Critical for Animal Health. 

  
  • In veterinary health, an adequate supply of compounded medications for office use is essential for the proper care and treatment of animal patients.   
 
  • Veterinarians perform medical procedures – including emergency procedures for which a patient cannot be identified in advance – which necessitate keeping compounded medications in stock in order to perform those procedures.   
 
  • Veterinarians need to keep compounded office stock medications on trucks to take to their immobile or non-transportable patients, whether at a farm, stable, or zoo, for which they cannot identify patients in advance.   
 
  • Veterinarians compound medications from bulk substances, or use components of approved drugs, that are customized for various animals they routinely treat given the specialized and varied nature of their practice. 
 
  • Compounded medications for animals are highly specialized depending on breed, size, and other factors, and need to be available for immediate administration.  
 
  • As one example, apomorphine is a drug that is used to treat poisoned animal patients; it is typically administered in a clinic to induce vomiting to rid the body of a poison.  It must be available as an office supply stock in veterinary practices so that it is available when it is needed. Delaying for even an hour could cause the death of the animal; providing an individual prescription in advance is not feasible.  There is no suitable commercially available apomorphine product for veterinary use.

 

This legal overview was commissioned by Professional Compounding Centers of America (PCCA). It is excerpted and republished here with permission.

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