Pharmacists play a critical role in safeguarding patient health by ensuring that every medication dispensed is authentic, safe, and sourced through legitimate channels. In addition to professional responsibilities, pharmacies must now comply with comprehensive federal requirements under the Drug Supply Chain Security Act (DSCSA), all of which became fully enforceable in November 2024. With DSCSA enforcement fully in effect and pharmacy boards increasing their focus on sourcing and supply chain integrity, it is essential for pharmacists to adopt a proactive compliance strategy.
At a state level, we have seen increased focus on sourcing and supply chain integrity, with a particular focus on GLP-1 products. Recently, the Arkansas Board of Pharmacy sent an inspector to investigate a suspect unit of Ozempic quarantined by an Arkansas pharmacy. When the inspector arrived at the pharmacy, it was discovered the quarantined Ozempic was not genuine. This led to an emergency hearing and the Board immediately suspended the license of the distributor who sold the product to the pharmacy. This highlighted a broader trend across the country: state pharmacy boards expect pharmacists to do more than simply dispense medications. Frier Levitt has seen a surge in requested transaction information and transaction statements for any transactions involving certain branded GLP-1 products. Pharmacists must ensure the medications they stock and dispense come from licensed, verified sources. This enhanced duty places pharmacists squarely at the center of regulatory enforcement, meaning any failure to properly vet suppliers could expose pharmacies to board investigations, civil liability, and significant reputational harm. For example, in previous years, Gilead Sciences filed a lawsuit against several pharmacies, alleging their involvement in a drug counterfeiting operation. The company accused these pharmacies of knowingly purchasing and distributing counterfeit versions of its HIV medications, thereby jeopardizing patient safety, and further underscoring enhanced duty placed on pharmacists.
While state boards are stepping up oversight, pharmacies must simultaneously meet evolving federal requirements. The DSCSA, originally enacted in 2013, reached its full enforcement phase on November 27, 2024, after a series of phased implementation deadlines. Under these final requirements, pharmacists must ensure they only receive prescription drugs accompanied by electronic transaction data, including transaction history, information, and a product statement (T3 data). Pharmacies must also confirm that every trading partner, whether a wholesaler, manufacturer, or supplier, is properly licensed and authorized. Serialization, or assigning unique identifiers to individual units of prescription drugs and having electronic systems for package-level tracing, has also been phased into DSCSA requirements.
In addition to verifying trading partners, pharmacists must have processes in place to investigate and quarantine any product suspected of being counterfeit, diverted, or otherwise illegitimate. If a suspect product is identified, pharmacists are responsible for conducting a product verification check, confirming the product’s unique serial number directly with the manufacturer. Pharmacies must maintain clear and complete records of all product movements and verification activities for at least six years, ensuring that this documentation is readily accessible during an inspection or audit. Thus, Pharmacies must now only accept serialized prescription drugs with electronic transaction data, maintain six years of transaction records, and verify product identifiers if a drug is suspected to be counterfeit. They must also have electronic systems to track and trace drugs, respond to verification requests within 24 hours, and quarantine any suspect products while notifying the FDA and trading partners.
The FDA has made it clear that pharmacies failing to comply with these requirements face serious consequences, ranging from regulatory fines to referral for federal enforcement action. State boards of pharmacy may also impose disciplinary action, including fines, probation, or suspension of a pharmacy license.
This evolving regulatory environment makes compliance a critical part of pharmacy risk management. Beyond the risk of regulatory fines and disciplinary action, pharmacies that dispense counterfeit or diverted medications—even unknowingly—face significant legal exposure if patients are harmed. If your pharmacy has not recently reviewed its sourcing policies, DSCSA processes, or vendor contracts, now is the time to act for a comprehensive compliance assessment on counterfeit drug detection and DSCSA compliance. This will protect your patients, your pharmacy, and your license, allowing the focus to remain on delivering safe, high-quality care to your community.
How Can Frier Levitt Help
As healthcare attorneys with deep experience representing pharmacists and pharmacies, we provide comprehensive compliance support tailored to the unique needs of pharmacy practice. Our services include DSCSA compliance audits, where we review your sourcing policies, recordkeeping, and vendor agreements to ensure your processes align with both state and federal expectations. Should your pharmacy face a board investigation or enforcement action, we provide strong representation to protect your license, reputation, and practice. We also assist with contract negotiation and review, ensuring your supplier agreements include critical protections such as warranties of DSCSA compliance, indemnification for counterfeit products, and clear record-sharing obligations. Contact us today to speak with an attorney.
