The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements.
The draft and final guidances are as follows:
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act – This is a revision of the guidance issued in May 2018 and is based on comments received to that draft. Specifically “this revised draft guidance: (1) provides for FDA’s current understanding of the term “stolen”; (2) identifies certain scenarios that are unlikely to result in diverted product; (3) revises the definition of “unfit for distribution” by tying it more closely to the language in the DSCSA and referencing “serious adverse health consequences or death to humans”; and (4) revises the definition of “fraudulent transaction” to apply to situations where information has been “knowingly” falsified.” The full revised draft guidance can be found here.
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification – This final guidance is the first revision to a December 2016 guidance of the same name and takes into account comments submitted to the Agency responding to the 2016 guidance. According to FDA, “The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers, in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. In addition, this guidance describes when manufacturers should notify FDA of a high risk that a product is illegitimate.” The full guidance can be found here.
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act – This draft guidance is another in a series of guidances issue in support of the “critical enhanced drug distribution security requirements for building an electronic, interoperable system by November 27, 2023.” The process has been phasing in since 2013; this is another step in that phase-in process. The FDA notes that “[T]his draft guidance clarifies the enhanced drug distribution requirements and describes recommendations for system attributes necessary for enhanced product tracing and enhanced verification, including when the use of aggregation and inference may be appropriate.” The full guidance can be found here.
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry – This final guidance is issued In a question and answer format and “is intended to help manufacturers and repackagers understand and satisfy the requirements of section 582(b)(2) and (e)(2) of the FD&C Act, respectively, to affix or imprint a product identifier to each package and homogenous case of product that they intend to introduce in a transaction into commerce.” The original draft guidance was issued on September 20, 2018 under the same name. Based on the comments received in response to the draft guidance, the Agency notes, “[A]mong the key substantive changes, we revised the recommendations regarding the expiration date format–specifically, we no longer recommend using a space between the day, month, and year; we now recommend using a hyphen or forward slash between the expiration date elements. In addition, we also modified our statements regarding use of the human readable GS1 Global Trade Identification Number to explain the importance of the three segment NDC format for patient safety. We also clarified how to affix or imprint multiple barcodes on the label with sufficient space to avoid confusion in reading or scanning. We made additional, editorial changes to improve clarity.” The full guidance can be found here.
These guidance documents are extremely important, as failure to fully comply with the Act’s requirements is a violation of the law. It is therefore essential that manufacturers, repackagers, wholesale distributors, and dispensers fully understand their requirements “to facilitate the tracing of product through the pharmaceutical distribution supply chain.” Remember, what started way back in 2013 will be a fully required in just a bit over 2 years! Hold onto your hats-the winds of change are just about upon us!
