September 16, 2020
November 27 marks the final milestone for pharmacies in the long journey toward the comprehensive overhaul of the pharmaceutical supply chain referred to as the Drug Supply Chain Security Act (DSCSA). Gradually implemented over the last seven years, the initiative aims to secure the supply chain with end-to-end unit-level traceability. Every link in the chain has had to undergo changes in how it receives and moves drugs, whether through new scanning systems, information databases, packaging, or procedures.
The last phase in the DSCSA rollout requires pharmacies to accept pharmaceutical products exclusively from trading partners with a DSCSA-compliant product identifier, with a few exceptions. Additionally, for products under suspect investigation, pharmacies must verify the product identifier of the suspect product of at least 3 packages or 10 percent of the product.
With this last requirement in place, pharmacies can breathe a sigh of relief. By now, you should already have the processes, procedures, and equipment in place to fulfill your part of the DSCSA. But just to be sure, we’ve put together a checklist with every DSCSA requirement for dispensers so you can have confidence that your pharmacy is compliant.
Pharmacies must verify that all trading partners have a valid license and are registered per federal and state law. Pharmacies should have protocols in place for routine verification for all new trading partners and be sure to regularly audit current trading partners. To verify licensure, search the WDD/3PL database at www.FDA.gov.
Pharmacies are required to identify and report suspicious products that may be illegitimate. Pharmacies should have procedures in place to:
Examples of suspect or illegitimate product:
1. Transaction information: This information, which can be provided in paper or electronic format, includes the name of the product, strength and dosage form, NDC, container size, number of containers, transaction date, shipment date, name and address of the seller and buyer, and lot number, if applicable.
2. Transaction history: This is a paper or electronic statement that includes the transaction information for each prior transaction of the product back to the manufacturer.
3. Transaction statement: This is a paper or electronic attestation transferring ownership of the product.
A product identifier is a standardized graphic that includes:
This info must be in both human- and machine-readable formats. The machine-readable format must include two-dimensional data matrix barcode for packages and a linear or two-dimensional data matrix barcode for homogenous cases.
Which products are exempt?
This article was published in our quarterly print magazine, which covers relevant topics in greater depth featuring leading experts in the industry. Subscribe to receive the quarterly print issue in your mailbox. All registered independent pharmacies in the U.S. are eligible to receive a free subscription.
Read more articles from the September 2020 issue:
PBA Health is dedicated to helping independent pharmacies reach their full potential on the buy side of their business. The company is a member-owned organization that serves independent pharmacies with group purchasing services, expert contract negotiations, proprietary purchasing tools, distribution services, and more.
An HDA member, PBA Health operates its own NABP-accredited (formerly VAWD) warehouse with more than 6,000 SKUs, including brands, generics, narcotics CII-CV, cold-storage products, and over-the-counter (OTC) products.
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