Tuesday, April 30, 2013

What The Proposed Federal Legislation Has to Say About Compounding from Bulk- Vets What Do You Have to Say? You Need to Be Voicing Your Opinions on How This Will Effect You!

Bulk Ingredient Qualifications and Restriction on Wholesaling

The bulk requirements in current section 503A are preserved, with one modification.  Current law requires that any drug compounded from bulk must use bulk active pharmaceutical ingredient that 1) either complies with an applicable United States Pharmacopoeia (USP) or National Formulary (NF) monograph, is part of an FDA-approved drug, or appears on a list established by the Secretary; 2) is manufactured in a registered establishment; and 3) is accompanied by a valid certificate of analysis.  The revised section 503A would permit the Secretary to identify a drug that only has an applicable USP or NF monograph as not suitable for compounding following the publication of the reasoning and consideration of comments submitted to a docket open for at least 30 days. Inactive ingredients also must comply with USP or NF.

If a drug is being compounded for a minor animal species, the same requirements on bulk chemicals apply. However, if a drug is compounded for a non-food major species or food-producing animal, compounding from bulk can only be performed if FDA has listed that bulk ingredient. The major species are cattle, horses, swine, chickens, turkeys, dogs, and cats. Minor animal species are all other species.

Compounded drugs may only be sold by the entity that compounded that product, and all must be labeled “not for resale”. It is a prohibited act to resell a product labeled “not for resale”. 

quoted from the Senate's section by section paper.

Do vets have a problem with this proposed new federal legislation?  If so, you need to get your comments submitted by the May 3, 2013 deadline.

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