The Drug Quality and Security Act

The Drug Quality and Security Act entered law in 2013 and baked into the comprehensive law was the Title 2 Drug Supply Chain and Security Act (DSCSA). The changes that the new law prescribed (see what we did there) were phased in over several years and as of 2021 have completely come into force.

The legislation was created with several goals in mind. Most prominently lawmakers sought to enact a federal-level prescription drug safety standard designed to increase quality control, and decrease contamination, counterfeiting, and other illegal, illicit activities. The law also improves the detection of and prevents the distribution of potentially unsafe drugs into the US Supply chain, thereby protecting American consumers and distributors.

According to PharmacyTimes,

DSCSA required that several key initiatives be implemented and maintained to ensure supply chain safety. These have included building an interoperable system for the handling of suspected counterfeit products and product serialization, tracing, and verification. Components of this regulation have been phased in over time, and manufacturers and suppliers have spent unspecified funds relabeling, retooling, and working on the supply chain with the ultimate goal of unit-level traceability by November 27, 2023.

The FDA describes the Drug Supply Chain Security Act (DSCSA) as, “enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.”

The most critical facets of the Drug Supply Chain and Security Act that are industry-required knowledge are:

• Product tracing. According to the Food and Drug Administration, Participants in the supply chain are now required to share product transaction history electronically with the next interoperable member of the chain until the product reaches the end-user. This places a significant documentation burden on distributors and pharmacists, given that this can be accomplished much more easily with present technology, this requirement is even being applied to smaller firms.
• Serialization. The serialization of products must be complete and added to each individually saleable unit for every prescription product and linked to batch number, expiration date and point of origin. This is intended to allow full traceability from end to end of the supply chain.
• Suspect product. Pharmacies and distributors must have processes and procedures in place as well as a segregated area of their facilities to store product that is unfit for distribution and may cause adverse health consequences or death and/or is counterfeit, diverted, stolen or fraudulent.
• Transaction history. A complete history of all transactions for each individual saleable item must be maintained and transmitted throughout the supply chain. This history must contain:
  • Transaction information. Names and addresses of the businesses involved in ll product transfers, dosage form, chemical or marketing name of a product, lot size, National Drug Code, container size, number of containers, product strength, and shipment and transaction dates.
  • Transaction statement. According to PharmacyTimes: “This is a document or electronic statement showing that the entity transferring ownership in a transaction did not deliberately provide false transaction information, knowingly alter the transaction history, or intentionally ship an illegitimate or suspect product; had processes and systems in place to comply with verification requirements under the law; received the product from an individual authorized as required under DSCSA; and received transaction information and a statement from the prior owner of the product, as mandatory under the law.”
• Verification. All companies in the supply chain must be able to produce relevant transaction documentation within 24 hours except dispensers who have 48 hours. Secure and backed-up data storage must comply with HIPAA and FDA regulations.

All of our partners, clients and fellow distributors up and down the supply chain should make sure that they are now in compliance with the DSCSA, as enacted in 2013 and gradually phased in over the last several years. Pharmacy managers, clinicians and providers should continue working with FDA approved partners to review their data retention requirements, operations and inventory tracking technology toe ensure that they meet the new legal and regulatory requirements. Most of all, know who you work with and know that you can rely upon them and their standards because at the risk of repeating ourselves: we’re all in this together. The stability and quality of the pharmaceutical supply chain is the responsibility of every businesses and stakeholder that are part of it.

Apotheca Wholesale Pharmaceuticals is well equipped and ideally suited to help your business wade through the uncertain changes that 2021 will bring. We have all of the qualities you’re looking for in a Pharmaceutical distributor and we’re in this together.

Contact us today at Customerservice@apothecainc.com or call us at 602-252-5244.