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.
1. Verify trading partners
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.
2. Identify and report suspect and illegitimate product
Pharmacies are required to identify and report suspicious products that may be illegitimate. Pharmacies should have procedures in place to:
- Identify suspect product currently in inventory and among new products
- Inform trading partners about suspect product
- Quarantine suspect product from regular inventory
- Remove illegitimate product from the supply chain
- Notify the Food and Drug Administration (FDA) and all trading partners within 24 hours after determining that a product is illegitimate
Examples of suspect or illegitimate product:
- Altered product information
- Missing information on the label
- Looks different than product on shelf
- No “Rx only” symbol
- Bubbling on label
- Foreign language
- Lot numbers or expiration dates do not match the outer/inner container
- Missing or wrong package inserts
- Damaged or broken seal
- Open package
- Different product name than FDA approved version
3. Accept and maintain transaction data
- Only accept product if the previous owner provides the transaction information, transaction history, and transaction statement (“3Ts”)
- Capture and maintain the “3Ts” for six years from the date of the transaction
- When selling or loaning product, provide the “3Ts” to the subsequent owner, unless the subsequent owner is a patient
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.
4. Accept only products with the proper product identifier
A product identifier is a standardized graphic that includes:
- The product’s standardized numerical identifier (the NDC and a unique alphanumeric serial number)
- Lot number
- Expiration date
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?
- Blood or blood components intended for transfusion
- Certain radioactive drugs or radioactive biological products
- Imaging drugs
- Certain intravenous products
- Any medical gas
- Homeopathic drugs
- Drugs compounded in compliance with sections 503a or 503b of the FD&C Act
From the Magazine
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:
- Point of care testing: a cash business opportunity for pharmacy
- The key to a thriving CBD offering
- How to make the most of the cash sitting in your bank
- The ultimate track-and-trace (DSCSA) checklist for pharmacies
- How the pandemic has changed the way independent pharmacies do business
- Attract more shoppers to your pharmacy with one simple device
- How to provide a successful Medicare open enrollment service
- Creating a successful employee schedule: advice from industry experts
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An HDA member, PBA Health operates its own NABP-accredited secondary wholesaler with more than 6,000 SKUs, including brands, generics, narcotics CII-CV, cold-storage products, and over-the-counter (OTC) products — offering the lowest prices in the secondary market.