Track-and-trace requirements go into effect on Friday

Starting Friday, November 27, 2020, pharmacies must buy and sell only products with a required “product identifier” on their packages. This requirement is part of the phased-in implementation of the Drug Supply Chain Security Act of 2013 (DSCSA), also known as the “track-and-trace” law. By Friday, dispensers should be familiar with this requirement and know what to do if a product identifier is not on the package when they receive products that require it. The product identifier is on most drug packages in both human-readable format and on a machine-readable 2D data matrix barcode.

“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,” said Ilisa Bernstein, PharmD, JD, FAPhA, APhA senior vice president of pharmacy practice and government affairs. “If unsure, check the transaction statement to see if a product identifier should be on the package."

In the transaction statement, the seller confirms that the product and information surrounding the sale are accurate, including that the seller did not knowingly ship a suspect or illegitimate product.

Most products packaged by manufacturers after November 27, 2018—although not all—must be affixed or imprinted with a product identifier that features the product’s National Drug Code, or NDC, plus a unique serial number, lot number, and expiration date. FDA stated in guidance that “[i]f the transaction [documentation] does not include a sale before November 27, 2018, and absent other indicia that a product may be suspect or illegitimate, the transaction statement is one indication that the product was in the pharmaceutical distribution supply chain before that date.”

Pharmacists who encounter products without a product identifier should determine whether the product is grandfathered or otherwise does not require one, because some prescription drugs are excluded from DSCSA. Excluded drugs include

  • Blood or blood components intended for transfusion
  • Radioactive drugs or biological products
  • Medical gases
  • Homeopathic drugs
  • Drugs compounded in compliance with section 503A or 503B
  • I.V. products intended for replenishment of fluids and electrolytes or calories
  • I.V. products used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions
  • Products intended for irrigation, or sterile water, whether intended for such purposes or for injection

DSCSA

Find more information at https://apha.us/FDA_DSCSA. The full scope of the grandfathering exemption is described in the FDA final guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, available at apha.us/Grandfathered.