FDA Releases DSCSA Guidance Plan for 2016

The U S Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) recently released insights regarding off-label communications, generics products, and pharmaceutical quality. More importantly, the FDA released the Drug Supply Chain Security Act (DSCSA) guidance plan for 2016.

There are 15 categories of guidance documents planned for 2016. Included: advertising, biopharmaceutics, biosimilarity, clinical/antimicrobial, clinical/medical, clinical pharmacology, clinical/statistical, drug safety, electronic submissions, generics, labeling, pharmaceutical quality/CMC, pharmaceutical quality/manufacturing standards (CGMP), pharmacology/toxicology and procedural. There is a total of 102 planned guidance documents, considerably more than what’s been planned in the recent past.

Additionally, the FDA has planned six guidance documents for DSCSA implementation. These guidance documents were carried over from last year, with the exception of Field Alert Submission. The other guidance documents are Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers; Products Eligible for Grandfather Status; Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs; The Product Identifier for Human, Finished, Prescription Drugs; Verification Systems for Prescription Drugs; Waivers, and Exceptions and Exemptions from Product Tracing Requirements.

The DSCSA guidance documents will offer information about reporting requirements and procedures, the status of products within a supply chain before a deadline, the exchange of information when tracing RX products, and exemptions for certain products and scenarios.  The agenda will outline steps that must be taken to build an interoperable system that traces prescription drugs as they are purchased in the U.S. Traceability should focus on T3 management, exchange and repository, and detection and response.