The Food and Drug Administration (FDA) does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information.

The Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA), mandates a full supply chain traceability system from pharmaceutical manufacturer to pharmacy dispenser for prescription drugs being distributed in the United States. Beginning July 1, 2015, DSCSA requires dispensers to track receive lot-level documentation on every product they purchase, including: 1. Transaction History (TH); 2. Transaction Information (TI); and, 3. Transaction Statement (TS). This information will be supplied by drug wholesalers and manufacturers. You must retain transactional product documentation for six years.

Beginning July 1, 2015, DSCSA requires dispensers to track receive lot-level documentation on every product they purchase, including: 1. Transaction History (TH); 2. Transaction Information (TI); and, 3. Transaction Statement (TS). This information will be supplied by drug wholesalers and manufacturers. You must retain transactional product documentation for six years.

The pharmacy industry continues to see consolidation in the prescription drug management business. This week UnitedHealth Group agreed to buy Catamaran Corp in a deal worth approximately $12.8 billion.

It has been widely reported that recent state court findings would allow the Health Insurance Portability and Accountability Act (HIPAA) requirements to be a new standard of care for health care providers in negligence legal actions. HIPAA does not provide a private right of action, but plaintiff’s attorneys are pursuing innovative state law approaches to enforcing patient privacy concerns

Beginning not later than January 1, 2015, a pharmacy shall have systems in place to enable the pharmacy to comply with DQSA Pharmacy Verification Requirements. Plus specific scenarios that could increase the risk of a suspect product entering the pharmaceutical distribution chain.