In September, FDA published “Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers Guidance for Industry”. Comments can be sent in here and are due by November 19, 2018. According to the agency, the guidance is intended to address anticipated questions regarding product identifiers required by the Drug Supply Chain Security Act (DSCSA) for packages and homogenous cases of certain drug products.
Drug Supply Chain Security Act
As the FDA explains, the DSCSA was signed into law on November 27, 2013. The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs as they are distributed within the United States. Section 202 of the DSCSA sets forth new definitions and requirements related to product tracing, product identifier, and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of product through the pharmaceutical distribution supply chain.
The Guidance
This guidance is intended to help manufacturers and repackagers understand the requirements to affix or imprint a product identifier on each package and homogenous case of product that they introduce in a transaction into commerce to satisfy the product identifier requirement of section 582 of the FD&C Act.
In particular, the guidance addresses linear barcode requirements under the law. FDA states that manufacturers and repackagers have asked the agency whether some products are still required to include a linear barcode. FDA notes that it published a rule requiring certain human drug and biological product labels to have a linear barcode that contains, at a minimum, the drug’s NDC number. Manufacturers, repackagers, relabelers, and private label distributors of human prescription drug products, biological products, and over-the-counter (OTC) drug products dispensed pursuant to an order and commonly used in hospitals are subject to the linear barcode requirement. The linear barcode must appear on the drug’s label as defined by section 201(k) of the FD&C Act (21 U.S.C. 321(k)). FDA has interpreted that requirement to mean the linear barcode should be on the outside container or wrapper, as well as on the immediate container unless the barcode is readily visible and machine-readable through the outside container or wrapper.
Additionally, FDA specifies that several prescription drug products are exempted from the linear barcode requirements. This includes prescription drug samples, allergenic extracts, intrauterine contraceptive devices regulated as drugs, medical gases, radiopharmaceuticals, and low-density polyethylene form fill and seal containers that are not packaged with an overwrap. In addition, the requirement does not apply to prescription drugs that are sold by a manufacturer, repacker, relabeler, or private label distributor directly to patients, unless versions of the same drug are also sold to or used in hospitals.
FDA addresses 19 guidance-specific questions later in the document and it may be of interest to relevant parties.