There are new requirements under the Drug Supply Chain Security Act (DSCSA) for drug manufacturers, re-packagers, wholesale distributors, dispensers, and trading partners. This includes almost all veterinarians and pharmacies. As these changes go into effect, you’ll need a solid understanding of how to handle suspect and illegitimate products, how to confirm authorized trading partners, and how to handle reporting licensure and work with your trading partners.
Do You Know How to Handle Suspect and Illegitimate Products?
Both pharmacies and veterinarians need to be able to identify suspect products to prevent both liability and harm to patients. Internally, you can establish systems designed to quarantine and investigate suspect products to determine if they are illegitimate. The FDA guidelines highlight several situations where heightened vigilance will be necessary, including:
- Purchasing from a new source
- Receiving unsolicited sales offers
- Purchasing on the Internet from an unknown source
- Purchasing products that are usually in high demand or difficult to find
- Purchasing products with a high sale volume or price
- Purchasing a product that has a history of being counterfeited
To prevent acceptance of illegitimate products the FDA suggests several procedures and recommendations like closely examining the label and packaging for missing information, altered information, or misspelled words. For more detailed and all-inclusive information on identifying illegitimate products, see the FDA draft of Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.
If an illegitimate product is found, you are required to notify the FDA and your immediate trading partners as soon as possible. The FDA recently restricted products from a Pfizer site in India due to problems with sterility. All issues were linked to a lack of scientific knowledge. It is crucial that we continue using only FDA registered facilities that are subject to inspection by the FDA to protect ourselves and the health of our patients.
Do You Know How to Confirm Authorized Trading Partners?
Check with your trading partner directly to confirm if they are authorized. This means if you are a veterinarian, check with your pharmacies to ensure they have the proper authorization. Your pharmacy should only get drugs through FDA registered facilities, ensuring safety and efficacy. For wholesale distributors, third party distributors, and dispensers, check with your respective state authority to confirm licensure.
Reporting Licensure and Working with Your Trading Partners
It is required that wholesale distributors and third party distributors report licensure and other information to the FDA. All trading partners must understand their responsibility and work together to facilitate efficient drug distribution and availability of drug products in the United States. Though it is a new way of doing things and an extra layer of security in an already highly monitored career, keep in mind that these new requirements are to enhance drug distribution security, not make more of a headache for veterinarians and pharmacies.
The Drug Supply Chain Security Act has several key requirements that pharmacies and veterinarians need to be aware of. The new requirements, development of standards, and the system for product tracing will continue to be phased in until 2023. The FDA is working to effectively implement the new requirements, however, all should be aware of these changes to allow for a smooth transition.
If you have questions about how the DSCSA will affect your pharmacy or change your practice, contact EPC to speak with one of our informed pharmaceutical staff.