By Derek Ishaque
Pharmacy News
August 02, 2015

Drug Quality & Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA)

We try and buy and stock medications ahead of any shortage.  However, in the case of a drastic shortage event we would go the extra mile for our clients and borrow medications from other providers for residents in need.  This new piece of legislation provides more stringent regulations that unfortunately limits our ability to borrow in the case of an emergency.

What are the Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA)?

The Drug Quality and Security Act (DQSA) established requirements on compounding safety and security of pharmaceutical products. Title II of DQSA, known as the Drug Supply Chain Security Act (DSCSA) applies to us and mandates consistent traceability of pharmaceutical products through the national supply chain from manufacturers to pharmacies. The new federal law negates all state pedigree requirements, implementing a national standard for traceability, and places the industry under the purview of the Food and Drug Administration (FDA).  

  •        On July 1, 2015, pharmacies and dispensers, including hospitals, independent retail pharmacies and alternative care facilities, will be required to accept and maintain records of the Transaction Information, Transaction History and Transaction Statement (TI, TH, TS) details, very much like the manufacturers and wholesalers were required to do on January 1. Pharmacies and dispensers will be required to hold transactional data for a six-year period.

Author Description

Derek Ishaque

Derek is the Owner and CEO of SCRx Pharmacy. He has previous experience in Investment Banking at Bear Stearns and private equity at Bridgescale Partners. Derek has a B.S. in Finance from USC.

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