On September 19, 2018, the USFDA published a Draft Guidance, Product Identifiers Under the Drug Supply Chain Security Act – Questions and Answers, [Docket Number FDA-2018-D-3175-0002]. This draft guidance introduced some recommendations that were, at the very least, confusing if not confounding to the pharmaceutical supply chain’s strategy, systems, and validated processes that have been widely adapted for compliance to the DSCSA regulation.
Keep in mind that the FDA is making “recommendations” for interpretation of the DSCSA law, not changes to the law itself. That said, when that document is published as a “final” guidance it will be used by FDA investigators as their guidance for inspection of the various supply chain partners (especially manufacturers and repackagers).
Excellis Health Solutions has performed a detailed analysis of the draft guidance. The attached document represents the comments, questions, and suggestions we will electronically post to the FDA regulations portal (www.regulations.gov).
It is very important that the public (responsible entities within the pharmaceutical supply chain) is active in submitting comments either electronically or written so that the confusion generated by the publication of this draft guidance can be eliminated. Submit your responses to the FDA through one of the following methods:
- Electronic: https://www.regulations.gov/docket?D=FDA-2018-D-3175
- Written: to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
Excellis Health Solutions remains vigilant to assist the pharmaceutical supply chain design and implement compliant solutions. For additional information visit our website: Excellis Health Solutions