Pharmacy Updates
FDA Releases Draft Guidance on Section 503B Fees for Outsourcing Facilities.
Section 503B of the Federal Food, Drug and Cosmetic Act (FDCA) created a new Food and Drug Administration (FDA) regulated entity called an ‘outsourcing facility.’ As discussed previously on the Baer Law Blog, a registered outsourcing facility is permitted to compound sterile drugs for human use with or without a prescription after voluntarily registering with…
Read MoreThe Drug Quality and Security Act: Compounding Guidance
In November 2013, President Obama signed the Drug Quality and Security Act (DQSA), a law that aims to address and improve the safety of the United States pharmaceutical supply and contains updates to the oversight systems for pharmaceutical compounding. In December 2013, the United States Food and Drug Administration (FDA) released (for public comment) six…
Read MoreIncreasing the Pharmacy Technician to Pharmacist Ratio: Is Patient Safety at Risk?
Florida House bill, HB 323, increases the number of pharmacy technicians a single pharmacist can supervise from a maximum of three to six. This bill, heard by the House Health Quality Subcommittee on February 5th, could significantly impact the profession of pharmacy and the health and safety of the patients in Florida, but other states are also considering…
Read MoreCompounding Update: Drug Quality and Security Act – Outsourcing Facilities
The Drug Quality and Security Act establishes and regulates a new class of compounding pharmacies called “outsourcing facilities.” What qualifies as an outsourcing facility? To qualify as an outsourcing facility, an entity must compound sterile drugs with or without patient specific prescriptions and comply with the Drug Quality and Security Act’s new rules, which include…
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…
Read MoreCalifornia Seeks to Expand the Practice of Pharmacy
Earlier this month, California Governor Jerry Brown signed a new California law that seeks to expand the scope of pharmacy practice within California and improve patient access to care. The bill would establish board recognition for advanced practice pharmacists who, starting January 1, 2014, will be able to perform the following tasks: Perform patient assessments;…
Read More