The pharmaceutical industry is quite complex. And due to its colossal size, it can be a challenge for industry leaders to stay on top of quality standards, which can result in counterfeit medications. And it has. As much as 10 percent of medications in the world are counterfeit.
The Food and Drug Administration (FDA) enacted the Drug Supply Chain Security Act (DSCSA) in 2013. At that time, it set a 10-year timeline for full implementation; and now, the deadline is only months away. November 27, 2023, marks the final milestone.
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 it’s through new scanning systems, information databases, packaging, or procedures.
The initial deadline in 2018 found many companies unprepared due to a lack of guidance from the FDA along with confusion about the requirements. Since then, the FDA has issued several pieces of draft guidance to help companies prepare for implementation in 2023.
“There are two titles to the Act,” said Fred Liner, Director of Information Technology at PBA Health. “The first title is a set of requirements. All members of the supply chain are to essentially verify the products, which means any product they receive within the prescription drug space. That includes protocols for examining, protocols for quarantining, any questions they have with legitimacy of the product, and requirements to report concerns with the validity of any product that they receive to the manufacturers or wholesalers. That’s Title One, and that went into effect almost immediately.”
The second title requires pharmacies to accept pharmaceutical products exclusively from authorized trading partners with a DSCSA-compliant product identifier. You’re also required to receive, store, and provide product tracing information. However, you can only accept prescription drugs accompanied by the transaction information, transaction history, and transaction statement. For products under suspect investigation, pharmacies are required to verify that the suspect product’s standardized numerical serial number, lot, expiration date, National Drug Code (NDC), and Global Trade Item Number (GTIN) for at least three packages–or 10 percent–of the ordered product (whichever is greater) matches what’s in the system. In other words, compare what’s in the physical to what’s in the electronic.
At this point in time, you should already have the processes, procedures, and equipment in place to fulfill your part of the DSCSA. If you’re not 100-percent confident, however, here’s a checklist listing every DSCSA requirement for dispensers.
Confirm that your trading partners are licensed and registered:
As a pharmacist, you are required to verify that all trading partners have a valid license and are registered per federal and state law. You should also have protocols in place or routine verification for all new trading partners and be sure to regularly audit current trading partners. Search the WWD/3PL database at www.FDA.gov to verify licensure.
Identify and properly handle suspicious and illegitimate drugs:
You are required to identify and report suspect products that may be illegitimate. You 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
- Promptly notify your upstream supplier after determining that a product is illegitimate
How to spot suspect or illegitimate product:
- Altered product information
- Looks different than product on shelf
- Missing information on the label
- No “Rx only” symbol
- Bubbling on label
- Lot numbers or expiration dates do not match the outer/inner container
- Foreign language
- Missing or wrong package inserts
- Damaged or broken seal
- Open package
- Different product name than FDA-approved version
Accept and maintain transaction data:
Pharmacies must:
- 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
A popular and valid solution that DSCSA allows is for your supplier to provide this for the items it ships to you.
The “3Ts”
- Transaction information: This information 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. This can all be provided in paper or electronic format.
- 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.
- Transaction statement: This is a paper or electronic attestation transferring ownership of the product.
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
All of this information must be in both human- and machine-readable formats. The machine-readable format has to include two-dimensional data matrix barcode for packages and a linear or two-dimensional data matrix barcode for homogenous cases.
Products that 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
More than half of the manufacturing space has already missed their hard date, and while signs of readiness have been observed as of late, many trading partners are still lagging in bringing together their capabilities in order to meet the 2023 interoperability goals.
Full DSCSA compliance has many implications for companies, which is why it’s important to start preparing now. Those that fail to comply may be liable for heavy fines and other penalties from the FDA. (As this goes live, there will be some additional regulations. Look for an updated article from us as the time nears.)
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.
More articles from the March 2023 issue:
- The Best Software Systems
- New Obesity Drug
- Unexpected Partnerships
- Adding a Private Label
- Get Ready for the DSCSA
- Allergy OTC Season
- Business Loans for Your Pharmacy
- Pharmacy Shortages
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PBA Health is dedicated to helping independent pharmacies reach their full potential on the buy-side of their business. Founded and run by pharmacists, PBA Health serves independent pharmacies with group purchasing services, wholesaler contract negotiations, proprietary purchasing tools, and more.
An HDA member, PBA Health operates its own NABP-accredited warehouse 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.
