Schedule 65 I B (Pharmaceuticals and Drugs) Removes Non-TAA Compliant Products from SIN 42-2A

The Trade Agreements Act (TAA), enacted in 1979, governs all trade agreements negotiated between the United States and foreign countries. All VA Federal Supply Schedule (FSS) contracts are subject to TAA restrictions, specifically that all products   must be   from the U.S. or  designated countries. Find a list of designated countries here.

Typically, if a product is only manufactured in a non-designated country, the FSS program will allow agencies to seek a non-availability determination waiver. The VA recognizes that brand name drugs are unique, single-source patented products. In addition, the VA understands that removing non-compliant drugs from contract could affect patient care.

Therefore, the VA drafted a Determination & Finding petitioning a change in the TAA policy for drugs/biologics  subject to the Veterans Health Care Act of 1992 (P.L. 102-585).  This law, which applies only to SIN 42-2A, controls the prices that Government agencies pay for VA-covered drugs. Such drugs include sole source and multi-source innovator drugs, biologics, and generic pharmaceuticals that are marketed under FDA license or a New Drug Application (NDA).

Early this year, the FSS decided to allow SIN 42-2A ‘covered/branded drugs’ already on a contract, to stay on contract, even though they may not be TAA compliant. This decision was a temporary place holder to ensure the government’s ability to obtain pharmaceutical products while FSS considered alternatives.

FSS management has now made a final decision to remove all SIN 42-2A ‘covered/branded drug’ products manufactured in “non-designated countries” from all 65 I B Schedule contracts. The FSS is requesting assistance in ensuring TAA compliance. FSS contract holders should look at   their 65 I B Schedule contract to determine if any products are manufactured in a “non-designated country.”

July 11, 2013 VA Press Release

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