Drugs

3 Drug Product Identifier Guidances

FDA has published three guidances relating to product identifier requirements under the Drug Supply Chain Security Act. A draft guidance, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers, is intended to address anticipated questions about product identifiers required for packages and homogenous cases of certain drug products. The draft includes Introduction, Definitions, Background, Scope of Guidance, Product Identifiers under the Drug Supply Chain Security Act, Compliance Policy for Product Identifier Requirements, Products That Are Subject to the Product Identifier Requirements, Linear Barcode Requirements, and Questions and Answers.

A final guidance, Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, describes the agency’s compliance policy with regard to a requirement related to product identifiers under the Drug Supply Chain Security Act that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce beginning not later than 11/27/17.” The policy in the document applies only to the requirements regarding product identifiers as described in the guidance. FDA says it will not take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of product before 11/27/18, a one-year delay in enforcement of the requirement.

Finally, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, addresses product distribution security provisions in the law and facilitates the tracing of products through the pharmaceutical distribution supply chain by requiring trading partners to exchange transaction information, transaction history, and a transaction statement when engaging in transactions involving certain prescription drug products. FDA says it is issuing the guidance to help trading partners understand their compliance obligations for packages and homogenous cases of product that are not labeled with a product identifier and that are in the pharmaceutical distribution supply chain at the time of the requirement’s effective date. The document specifies whether and under what circumstances such packages and homogenous cases of product shall be subject to the grandfathering exemption from certain requirements of the law.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome