Posts Tagged ‘Drug Quality & Security Act’
Veterinary Compounding: For "Office Use"
As the veterinary compounding market continues to grow and expand, new legal issues arise and, in some instances, the current federal and/or state laws may be in conflict with one another or they may not provide clear guidance on specific topics. Veterinary compounding for ‘office use,’ where a medication is compounded and then sold to…
Read MoreFDA's Guidance on Compounding for Human Use
As discussed previously on the Baer Law Blog, Title I of the Drug Quality and Security Act (DQSA) gives the Food and Drug Administration (FDA) new powers to oversee drug compounding. Section 503A of the DQSA sets out certain requirements for traditional compounding, while Section 503B creates a new entity called outsourcing facilities. This blog…
Read MoreCompounding Pharmacy Update: Drug Quality and Security Act
This week, Congress took the final step in approving the Drug Quality and Security Act, a bill that amends the Federal Food, Drug and Cosmetic Act with respect to the regulation of human drug compounding and drug supply chain security. The bill addresses the practice of compounding which has expanded drastically over the past two decades…
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