The bill was written in response to the new england compounding center meningitis outbreak that took place in 2012, which killed 64 people. In november 20, president barack obama signed the drug quality and security act, aimed at regulating compounding pharmacies and establishing a trackandtrace pedigree system for drugs. On november 27, 20, president obama signed the drug quality and security act dqsa public law 154, amending the federal food drug, and cosmetic act fdca to address issues related to oversight of the practice of drug compounding, and incorporates a national prescription drug track and. Be it enacted by the senate and house of representatives of the united states of america in congress assembled, section 1. Compounded medications must be labeled with the following. The dqsa amends the federal food, drug, and cosmetic act ffdca by revising section 503a and adding a new section 503b 1,2. The drug supply chain security act of 20 the drug supply chain security act dscsa was signed into law on november 27, 20, as title ii of the drug quality and security act of 20. Dscsa creates national requirements for tracing pharmaceuticals across the supply chain, preempting any statelevel traceability requirements see figure 1. The drug supply chain security act dscsa of 20 created a national system in which companies involved in pharmaceutical distribution work together to safeguard the u. Pharmacies play a critical role in preventing unsafe products from reaching consumers. The act is an attempt by congress to bring some compounding pharmacies that use certain bulk. The bill ensures the safety of drugs for patients and the. Drug supply chain security act title ii of the drug quality and security act overview of product tracing requirements september 2015.
Iacp comparison of 503a and 503b the drug quality and. Drug supply chain security act below is information gathered by mmcap infuse to assist members with the drug quality and security act dqsa. An outsourcing facility is defined as a facility at one geographic location that compounds sterile drugs. The drug quality and security act is a law that amended the federal food, drug, and cosmetic act to grant the food and drug administration more authority to regulate and monitor the manufacturing of compounded drugs.
This act may be cited as the drug quality and security. The drug quality and security act of 20 section 503a traditional compounder section 503b outsourcing facility labeling no label requirements within 503a. This is a compounded drug or a reasonable comparable. The purpose of the drug supply chain security act dscsa was to create an electronic system to track and trace certain prescription drugs in the united states. Drug quality and security act the drug quality and security act would address two important issues affecting the quality and security of americas drug supply. The act addresses issues related to oversight of the practice of drug compounding, and incorporates a national prescription drug track and trace system. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or. The drug quality and security act dqsa pdf file 5 pages. Fda clarifies trackandtrace requirements for pharmacists apha makes agency aware of professions concerns activity around the drug supply chain and security act dscsa, better known as track and trace, is picking up, with fda releasing several draft guidances to help implement the law, which have a direct impact on pharmacists. The law regulates transactions between dispensers and pharmacies and also among manufacturers, repackagers, wholesale distributors, thirdparty logistics providers, and trading partners. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the. 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. The drug supply chain security act title ii, drug quality and security act, 20 addresses risks in the pharmaceutical distribution supply chain by establishing a national system that allows stakeholders and regulators to trace each package of product. The drug quality and security act dqsa, was enacted by congress on november 27, 20.
What are the drug supply chain security acts key provisions. The drug quality and security act contains two titles. However, the dqsa has had dire repercussions on patient access to drugs. The drug supply chain security act is one component of the drug quality and security act.
To amend the federal food, drug, and cosmetic act with respect to human drug compounding and drug supply chain security, and for other purposes. This act may be cited as the drug quality and security act. The drug quality and security act pubmed central pmc. This particular act requires the fda to implement a national trackandtrace system by which manufacturers must affix product identifiers barcodes to each package of product that is introduced into the supply chain.
Except as otherwise specified, amendments made by this act to a section or other provision of law are amendments to such section or other provision of the federal food, drug. However, the dqsa has had dire repercussions on patien t access to drugs. The dqsa is divided into 2 titles, illustrated by figure 1. Implementing the drug quality and security act on nov. Pharmacy implementation of the drug supply chain security act. Drug supply chain security act information minnesota. One hundred thirteenth congress of the united states of. First, the bill would clarify laws related to human drug compounding in response to the nationwide meningitis outbreak one of the largest public health crises in recent memory. Drug quality and security act serialization white paper. The drug quality and security act aims to regulate compounding pharmacies and establish a trackandtrace pedigree system for drugs, but it falls short on. The drug quality and security act mind the gaps nejm. Bipartisan, bicameral legislation to address highrisk drug compounding practices and secure the pharmaceutical supply chain. The drug supply chain security act dscsa is one of two titles that comprise the drug quality and security act dqsa which was signed into law by president obama on november 27, 20.
A national spotlight was shone on the safety of compounded pharmaceutical products with the 2012 multistate outbreak of fungal meningitis and other infections due to contaminated steroid injections produced by the new england compounding center necc in framingham, massachusetts. Title i is known as the compounding quality act cqa. Title i covers drug compounding and title ii relates to drug supply chain security. Outsourcing facilities remain subject to cgmp requirements. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements. Ffdca 503a on the government publishing office website 1. The serialization and traceability requirements will be phased in over the next 10 years.
Timeline for the drug supply chain security act the pew. The drug supply chain security act dscsa is one of two titles that comprise the drug quality and security act dqsa, which was signed into law by president obama on november 27, 20. 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. The drug quality and security act dqsa, or the act, which was passed in 2012, attempted to maintain the vital practice of compounding while increasing regulation over compounding pharmacies. On november 27, 20, the president signed into law the drug quality and security act dqsa. Except as otherwise specified, amendments made by this act to a section or other provision of law are amendments to such section or other provision of the federal food, drug, and cosmetic act 21 u. Fda clarifies trackandtrace requirements for pharmacists.
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