Title ii of the drug quality and security act dqsa is referred to as the drug supply chain security act dscsa. Regulatory developments affecting pharmacy practice. The act is an attempt by congress to bring some compounding pharmacies that. Pharmacy implementation of the drug supply chain security act. The drug quality and security act essay 585 words bartleby. The drug supply chain security act dscsa, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the united states. The bill was written in response to the new england compounding center meningitis outbreak that took place in 2012, which killed 64 people.
This act may be cited as the drug quality and security act. The drug supply chain security act dscsa the drug supply chain security act dscsa the act, title ii of the drug quality and security act signed into law in late 20 i, creates a system to identify and trace certain prescription drugs distributed within the united states, thus. The drug quality and security act dqsa of 20 differentiated a traditional compounder from an outsourcing facility. Drug supply chain security act below is information gathered by mmcap infuse to assist members with the drug quality and security act dqsa. Drug supply chain security act information minnesota. On the 25th of september 20, the drug quality and security act, also known as h. What are the drug supply chain security acts key provisions. Be it enacted by the senate and house of representatives of the united states of america in congress assembled, section 1. Title ii of the drug quality and security act dqsa, dscsa, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as. Timeline for the drug supply chain and security act.
On the 18th of november, this act cleared the senate. The integrity of the pharmaceutical supply chain is threatened by medication counterfeiting, importation of unapproved and substandard drugs, and grey markets all of which have the potential to distribute drug products with the. The drug supply chain security act dscsa was signed into law by president obama on november 27, 20. 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. Title ii of the drug quality and security act, the dscsa, was signed into law by president barack obama on november 27, 20, with a phased implementation over 10 years eventually leading to a fully interoperable, electronic system for the tracking and tracing of products throughout the supply chain. 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.
They cited duplicating product sampling and laboratory testing of 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 as they are distributed in the united states. Drug quality and security act and overseeing the safety of compounded drugs in late 2012, the united states faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. The drug supply chain and 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. Drug supply chain security act addresses concerns relating to counterfiet, falsified and substandard prescription medication. 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. The passage of the drug quality and security act of 20 dqsa updates the federal food, drug, and cosmetic act fdca in the areas of human drug compounding and drug supply chain security. One hundred thirteenth congress of the united states of. On the 27th of september, 20, president barack obama signed the drug quality and security act into law cite 2. Pharmacy technician federal laws flashcards quizlet. Its goal is to enable complete tracking of a product from the manufacturer to the dispenser.
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. 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. The dqsa amends the federal food, drug, and cosmetic act ffdca by revising section 503a and adding a new section 503b 1,2. The bill ensures the safety of drugs for patients and the.
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. Upon completion of this activity, participants will be better able to. Drug supply chain security act dscsa frequently asked. Guidance for industry drug supply chain security act implementation. Pharmacies may choose to check these numbers and verify products.
Inspection of drug manufacturers for compliance and good manufacturing processes. Pdf the drug quality and security act researchgate. Review of the 2015 drug supply chain security act erich. 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. An outsourcing facility is defined as a facility at one geographic location that compounds sterile drugs. The drug quality and security act educational objectives. The act addresses issues related to oversight of the practice of drug compounding, and incorporates a national prescription drug track and trace system inclusive of standards for prescription drug wholesale.
Deputy director, office of compliance center for drug evaluation and research u. Drug quality and security act overview and implementation dqsa drug quality and security act title ii track and trace. Fda clarifies trackandtrace requirements for pharmacists. Brechtelsbauer ed, pennell b, durham m, hertig jb, weber rj. The drug quality and security act dqsa was signed into law on november 27, 20. The drug quality and security act dqsa, or the act, which was passed in. To amend the federal food, drug, and cosmetic act with respect to human drug compounding and drug supply chain security, and for other purposes.
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. The drug supply chain security act the dscsa, enacted as part of the drug quality and security act in november 20, created a federal framework to address vulnerabilities in. Under drug supply chain security act dscsa requirements, dispensing pharmacies must. Title ii of this act, known as the drug supply chain security act dscsa, a set of requirements and phased compliance dates have been established for prescription drug manufacturers and other participants in the distribution chain. Us drug supply chain security act dscsa compliance. The drug supply chain security act explained rxtrace. Title ii of dsqa, known as 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 u. Dscsa creates national requirements for tracing pharmaceuticals across the supply chain, preempting any statelevel traceability requirements see figure 1. The drug quality and security act dqsa of 20 law outlines critical steps to build a system to identify and trace certain prescription drugs. The drug quality and security act dqsa, was enacted by congress on november 27, 20. Food and drug administration nabp district 4 meeting november 5, 2014. This act may be cited as the drug quality and security. The drug supply chain security act requirements are almost fully upon us. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or.
Quality and security act dqsa to address vulnerabilities in the drug supply. Implementing the drug quality and security act ncsl. 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. An 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. Pharmacies play a critical role in preventing unsafe products from reaching consumers. The drug quality and security act pubmed central pmc. 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. The serialization and traceability requirements will be phased in over the next 10 years. The secretary shall, not later than 2 years after the date of enactment of the drug supply chain security act, establish by regulation standards for the licensing of persons under section 503e1 as amended by the drug supply chain security act, including the revocation, reissuance, and renewal of such license. The secretary shall implement subsection a in consultation with the national association of boards of pharmacy.
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. The act is laudable in its efforts to protect patient safety. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Identification of suspect product and notification guidance for the drug industry. 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. The law regulates transactions between dispensers and pharmacies and also among manufacturers, repackagers. Pdf on jul 1, 2014, michael gabay and others published the drug quality and security act find, read and cite all the research you need on researchgate. Discuss the issues that led to the introduction and passage of the drug quality and security act dqsa. Even before the drug quality and security act dqsa was passed last november i began to study title ii, the drug supply chain security act dscsa but as soon as it was passed, i began to devote all of my spare time to that study.
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