The Food and Drug Administration (FDA) confirmed that all dispensers such as pharmacies will have to meet requirements that go into effect on Friday, Nov. 27, regardless of the American Pharmacists Association's (APhA) concerns that not all of the Drug Supply Chain Security Act requirements are undermined by COVID-19 pandemic responses.
This is the reason APhA and other pharmacies are requesting that the FDA delay the new requirements from the Drug Supply Chain Security Act (DSCSA), according to a press release from APhA.
"Starting Nov. 27, pharmacies must buy and sell—what the track-and-trace law refers to as 'engaging in transactions'—only products with a required 'product identifier' on their packages. Most products—although not all—packaged by manufacturers after Nov. 27, 2018, must be affixed or imprinted with a product identifier that features the products’ National Drug Code (NDC) plus a unique serial number, lot number, and an expiration date," APhA said in its press release.
Pharmacies and other dispensers will need to have processes that identify the packages they receive.
"The challenge for dispensers is that not all drug product packages are required to have a product identifier, and there is no central database to check if a product should have one," Ilisa Bernstein, PharmD, JD, FAPhA, APhA senior vice president of pharmacy practice and government affairs, said in the press release. "If unsure, check with the manufacturer to see if a product identifier should be on the package."
On Oct. 18, the FDA issued guidance to help pharmacies know how to request the DSCSA be delayed.
"For suspect and illegitimate product, dispensers must still quarantine product, conduct investigations and disposition illegitimate product," Bernstein said in the press release.
Current requirements for dispensers include: Accepting ownership of a product should only be done if the previous owner can provide transaction history; they must be able to provide subsequent owners of the product; they must reply to FDA requests; and they must only engage in transactions with authorized partners.
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