Alcohol, Tobacco, Firearms, and Explosives Bureau August 28, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled ``Nonproprietary Naming of Biological Products.'' The draft guidance describes our current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. Our current thinking is that shared nonproprietary names are not appropriate for all biological products. There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. Accordingly, for biological products, we intend to designate a nonproprietary name that includes a suffix composed of four lowercase letters. Each suffix will be incorporated in the nonproprietary name of the product. This naming convention is applicable to biological products previously licensed and newly licensed under the PHS Act. The nonproprietary name designated for originator biological products, related biological products, and biosimilars will include a unique suffix. However, FDA is considering whether the nonproprietary name for an interchangeable product should include a unique suffix, or should share the same suffix as its reference product. FDA invites comment on the draft guidance and solicits comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for tobacco retailers entitled ``Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.'' The guidance represents FDA's current thinking with respect to imposing no-tobacco-sale orders (NTSOs) on retailers who have committed repeated violations of certain restrictions on the sale and distribution of tobacco products. This guidance discusses, among other things, the period of time covered by an NTSO and a retailer's compliance with an NTSO.