Saturday, August 9, 2014

AHI points out that PCCA has received an FDA warning letter previously about compounding from bulk substances for use in animals being prohibited by the FDCA

Compounder Claims


In an email circulated to veterinarians, a large seller of bulk drug substances boldly proclaims there is no law

prohibiting the compounding of drugs from bulk drug substances for use in animals.

“[T]he AHI and AVMA currently claim that all compounding from bulk ingredients for animal use is illegal.



In fact, there is no such law!” – Jim Smith, President, Professional Compounding Centers of America, email

circulated March 11, 2013.

This bold statement is erroneous. ALL compounding from bulk drug substances for use in animals is



prohibited by the FDCA. The Professional Compounding Centers of America has even been notified of this

by FDA in an official Warning Letter:

“Most animal drugs compounded by a pharmacist are in violation of section 501(a)(5) of the Act because

they are new animal drugs, which are not approved, when they bear directions for use in animals. Unlike

human drugs, animal drugs are not covered by section 503A, Pharmacy Compounding, of the Food and

Drug Administration Modernization Act. Therefore, animal drugs compounded from active

pharmaceutical ingredients are subject to the same approval requirements as manufactured animal

drugs. The exception to this is found in the Animal Medicinal Drug Use and Clarification Act (AMDUCA)

codified at 21 CFR part 530.13, which legalized the compounding of animal drugs from already approved

products.” http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2001/ucm178377.htm.

quoted from here

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