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IACP Requests Comment Period Extension for FDA/Compounding Animal Drugs from Bulk Drug Substances

Monday, July 27, 2015   (0 Comments)
Posted by: Dagmar Anderson
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Today, July 27th, the International Academy of Compounding Pharmacists (IACP) requested a formal 90-day extension of the comment period for the Food & Drug Administration's (FDA) Guidance for Industry (GFI): Compounding Animal Drugs from Bulk Drug Substances from August 17, 2015 to November 2015.

 

In a letter sent to FDA, David G. Miller, RPh, IACP Executive Vice President/CEO says, "IACP is gravely concerned with many issues within this GFI that create distinct conflicts with existing State regulated pharmacy practice laws and regulations, that authorizes the preparation and distribution of veterinary medications by 503B outsourcing facilities without the necessary enabling statutory authority from Congress, and will have a detrimental impact on the availability of medications for use by veterinarians in the care and treatment of animals within their practices.

 

"On July 15, 2015, FDA announced a formal 90-day extension to the nomination process it established within the GFI for bulk drug substances (FDA-2015-N-1196-0003) which should be considered appropriate for compounding by veterinarians, pharmacists and other health care practitioners. That extension was published formally in The Federal Register one week ago on July 20, 2015. IACP believes that the extension for nominations of bulk drug substances is directly linked and derived from the Guidance For Industry itself and believes that an extension for the GFI is appropriate at this time."

 

IACP Letter Sent to FDA, Requesting Comment Period Extension

 

Please click here to read the entire IACP letter.


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