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
No comments:
Post a Comment