As the DSCSA rolls out, pharmacists play a crucial role protecting patients and the integrity of the drug supply
Under the Drug Supply Chain Security Act, pharmacists must follow certain requirements to protect patients from receiving counterfeit or substandard drugs. These include:
Verifying licensing or registration for trading partners:
- Check manufacturers' and repackagers' registration
- Check wholesale distributors' and third-party logistics providers' licensing.
- Check the licensing of pharmacies through the respective state authority.
- Resource: The FDA has published draft guidance on the topic of how one can verify the licensing or registration of a trading partner. (July 2022)
Managing tracing documentation
Pharmacies can only accept prescription drugs with the correct product tracing documentation: the transaction information, history, and statement. If the trading partner you purchased the drugs from does not provide all this documentation, work with them to promptly get it.
Pharmacies are also responsible for maintaining this documentation in paper or electronic format for six years, and must provide it to trading partners if you sell them a prescription drug.
Investigating and properly handling suspect and illegitimate drugs
Pharmacies must investigate and handle suspicious prescription drugs, including those that may be counterfeit, diverted, stolen, intentionally adulterated, otherwise unfit for distribution. When faced with a suspect product, pharmacists must quarantine and investigate the prescription drugs to determine if they are illegitimate.
If they are illegitimate, pharmacies should work with the manufacturer and take specific steps to ensure patients do not receive the illegitimate drugs.
Pharmacies must also notify FDA and the trading partners they bought the drug from and sold the drug to.
Want a crash course on DSCSA for pharmacists? We've excerpted the core part of PSM's "DSCSA for pharmacists" talk in this 35 minute video below.
Supporting Pharmacy Associations
PSM is highly focused on the needs of pharmacists and supports state pharmacy associations by providing them resources, free CE speakers, articles, and other tools to help educate their community. Learn more.
Are you part of a group of pharmacists looking for training on the DSCSA? Contact PSM Executive Director Shabbir Imber Safdar at firstname.lastname@example.org.
This flyer from the FDA reviews pharmacists' responsibilities under the DSCSA. The FDA maintains resources for pharmacists here.