Nov 24 2020

Pharmacies Face November 27 DSCSA Product Identifier Compliance Deadline

When the U.S. Congress passed the Drug Supply Chain Security Act (DSCSA) in 2013, it outlined a timeline for implementation of key provisions among various stakeholders, with full implementation expected by 2023.

Several of those implementation dates have been affected by the COVID-19 public health emergency, with the U.S. Food and Drug Administration postponing certain deadlines and issuing clarifying guidance with regard to others, For the nation's pharmacies this means a three-year postponement for some provisions, while a November 27, 2020 deadline remains in effect for compliance with certain product identifier requirements.

According to the American Pharmacists Association (APhA) staring November 27, pharmacies must buy and sell "only products with a required 'product identifier' on their packages. Most products – although not all – packaged by manufacturers after November 27, 2018 must be affixed or imprinted with a product identifier that features the product's National Drug Code (NDC) plus a unique serial number, lot number, and expiration date."

Pharmacies must have a process in place to ensure a product identifier is in place on a package when it is received. Pharmacies are not, however, required as of now to scan product bar codes upon receipt.

The APhA had requested a delay in this implementation date, since putting the required process in place would divert staff time and resources away from ongoing pandemic-related activities. The association argued that, even though most products received after November 27, 2020 will include a product identifier, "dispensers will be challenged to check every package for the product identifier."

Although this implementation date remains in place, the FDA did accommodate other industry requests for extensions.

In May 2020, leading pharmacy groups including the APhA, the National Community Pharmacists Association (NCPA), and the National Association of Chain Drug Stores (NACDS) wrote to the FDA with two specific requests:

  1. The FDA not take action against a dispenser for engaging in transactions involving a product purchased from an authorized trading partner that is not coded with an applicable product identifier.
  2. The FDA not take action against a dispenser who does not conduct an investigation to verify whether the lot number of a suspect product corresponds with the lot number for such product, and verify that the product identifier, including the standardized numerical identifier corresponds with the product identifier for such product.

This request was reiterated in a second letter, sent in mid-October. In that letter, APhA Executive Vice President and CEO Scott Knoer urged the FDA to act on the request, noting "this request's immediacy is not overstated."

Knoer noted that without a delay in FDA enforcement, "many supply chain members must perform substantial modifications to operations, procedures and staffing to allow the 'lead time' needed to fully establish compliance by November 27." This, Knoer said, would divert critical resources away from pandemic-related services, including preparation for vaccine administration.

The FDA with an announcement that enforcement of these two provisions would be delayed by three years, to November 27, 2023.

As pharmacies ensure their readiness for the upcoming 2020 deadline, the APhA advises that, should a drug product package arrive without a product identifier, the pharmacy staff should "check with the manufacturer to see if a product identifier should be on the package."

Worth noting is that despite seeking implementation delays, the pharmacy group expressed its strong support for the goals of the DSCSA. The group's objections were solely based on the all-consuming impact the COVID-19 pandemic has had on pharmacy staff and resources.