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In accordance with the DQSA, pharmaceutical manufacturers are required to provide lot level transaction information (TI), transaction history (TH) and transaction statement (TS) of all shipments. Find out more about the DQSA and how it matters to consumers and medical professionals.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
DQSA compliance will maximize consumer safety by standardizing track and trace requirements, lot-level traceability and overall supply chain security.
The supply chain for genuine pharmaceuticals has grown longer, and every step in the chain offers an opportunity for counterfeiters
The MedProID suite of products helps life science companies in achieving the license validation requirements for Drug Quality & Security Act (DQSA) compliance.
Compounded drugs can serve an important medical need for certain patients, they also present a risk to patients.
On November 27, 2013, President Obama signed into law the Drug Quality and Security Act (DQSA). For much of 2014, the industry will be dealing with the impact of this new legislation as the FDA establishes the rules by which this law will be put into practice. There may also be additional legislation on the horizon, addressing how compounded preparations are used in veterinary medicine. As a summary, the compounding provisions of the new law essentially reinstate section 503A of the Food, Drug and Cosmetic Act, written in 1997, minus the advertising restrictions deemed unconstitutional by Federal Courts. It also created section 503B, which establishes a new voluntary category of compounders called “Compounding Outsourcing Facilities.” This new type of FDA-regulated business has its feet planted in both the pharmacy and the manufacturing worlds. For more information, click here.
The Drug Supply Chain Security Act (DSCSA) requires dispensers, which primarily include pharmacies, to comply with new requirements related to product tracing beginning July 1, 2015. The FDA has issued a guidance, DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (Revised), announcing that it is extending a previously issued Compliance Policy from November 1, 2015 […]
