United States: Congress Drafts Compounding Legislation -- Defines Compounded Drugs As "New Drugs" Under The FFDCA And Creates Bright Line Between "Traditional Compounders" And "Compounding Manufacturers"

United States: Congress Drafts Compounding Legislation -- Defines Compounded Drugs As "New Drugs" Under The FFDCA And Creates Bright Line Between "Traditional Compounders" And "Compounding Manufacturers"

05 May 2013

Article by Rachael G. Pontikes  and Elinor L. Hart 

In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on Health, Education, Labor & Pensions ("HELP") released proposed legislation("Proposal") aimed at regulating compounding pharmacies. The Proposal makes compounds "new drugs" under the Federal Food, Drug, and Cosmetic Act ("FFDCA"), subjecting all compounds to federal regulation. The Proposal also draws a bright line, defining some compounders as "traditional compounders," and creates a new category called "compounding manufacturers." While the legislation has a long road until it becomes law, compounding pharmacies should consider closely analyzing the provisions now, as the Proposal fundamentally changes the regulation of compounding pharmacies.

What Is a "Compounding Manufacturer" Under the Proposal?

Compounding pharmacies are presently licensed under state pharmacy laws. The Proposal, however, divides compounding pharmacies into two categories for purposes of federal regulation: (1) traditional compounders and (2) compounding manufacturers.

Under the Proposal, a traditional compounder would be limited to entities where a drug is compounded by a licensed pharmacist, physician or veterinarian that compounds the drug either (1) upon receipt of a prescription order for an identified individual patient or (2) in limited quantities before receipt of a prescription order for an identified individual patient in certain limited circumstances.¹ Although a traditional compounder would continue to be state licensed pharmacies, under the Proposal, it would be subject to additional federal requirements.

However, a compounding manufacturer would be defined as an entity that compounds a sterile drug prior to receiving a prescription and introduces the drug into interstate commerce.²The new definition of compounding manufacturer also includes entities that pool sterile products or that repackage sterile, single-use, preservative-free vials. Under the Proposal, compounding manufacturers cannot be licensed as pharmacies under state laws.

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