Insight - Fall 2020

Fall 2020 | 24 Drug Supply Chain Image Source: www.pharmaceuticalprocessingworld. com/experts-comment-on-fdas-dscsa-serialization- extension-manufacturers-now-have-until-2018 Starting November 27, 2020, dispensers are to verify product identifiers when investigating suspect product. There is a common misconception that the verification requirement of product identifiers applies to all products whereas the requirement for dispensers only applies to suspect products. Starting November 27, 2020, dispensers must verify the product identifier of suspect product under investigation for “at least 3 packages or 10 percent of such suspect product, whichever is greater, or all packages, if there are fewer than 3.” 13 Verification or Verify means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with section 582. 14 Verification of product identifiers may occur by human-readable or machine-readable methods. 15 There are some solution providers offering abilities to scan suspect products into their solution and send a verification request to manufacturers, but other methods may be used as well, such as phone calls, emails, and/or file transfers. It is important that dispensers adopt a method that best suits their needs and keep staff informed on policies and procedures. It is also important to note that the verification requirements for November 27, 2020 do not apply to every product the pharmacy receives and only applies to a suspect product investigation; the grandfathering policy applies to products in the supply chain before November 27, 2018. 16-17 Recent Notice: FDA Announced a 3-year Delay in Enforcement for Dispensers On October 22, 2020, the FDA published new guidance that it will delay enforcement for the requirements of dispensers to verify the product identifier for suspect and illegitimate product that was to be effective on November 27, 2020 to November 27, 2023. The 3-year delay comes upon the expression of concerns over logistics and disruptions in the supply chain due to the COVID-19 pandemic from various stakeholders and representative organizations. Notably, APhA, ASHP, HDA, NASPA, NACDS, and NCPA expressed concerns in two joint letters sent to the FDA in May and October urging for delays in enforcement discretion. 18 “ FDA does not intend to take action against dispensers who do not verify the statutorily-designated portion of product identifiers of suspect or illegitimate product before November 27, 2023. This policy represents a 3-year delay in enforcement of the requirements for dispensers to verify the product identifier when investigating suspect or illegitimate product. ” 19 * This material is for informational purposes only and does not constitute legal advice. Sources: 1,2,11-17 Title II of the Drug Quality and Security Act. U.S. Food & Drug Administration. 12/16/14. Web. Accessed: 10/08/20. https://www.fda.gov/drugs/drug-supply-chain- security-act-dscsa/title-ii-drug-quality-and-security-act 3-9 Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier: Guidance for Industry. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Office of Regulatory Affairs (ORA). September 2018. Web. Accessed: 10/08/20. https://www.fda.gov/media/109591/ download 10 Review of the 2015 Drug Supply Chain Security Act. Brechtelsbauer, Erich, Pharm.D., et al. June 2016. Web. Accessed: 10/08/20. www.ncbi.nlm.nih.gov/pmc/articles/ PMC4911992 18-19 Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product -- Compliance Policies; Guidance for Industry; Availability. Department of Health and Human Services and the Food and Drug Administration. 10/23/20. Web. Accessed: 10/26/20. https://public-inspection.federalregister.gov/2020-23524. pdf