Baer Law Blog - Latest Updates
FDA Preparing a List of Bulk Drug Substances for Compound Drug Products
The Food and Drug Administration (FDA) is preparing a list of bulk drug substances that outsourcing facilities…
FDA Releases Draft Guidance on Section 503B Fees for Outsourcing Facilities.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…
The Drug Quality and Security Act: Compounding Guidance
In November 2013, President Obama signed the Drug Quality and Security Act (DQSA), a law that aims…
Increasing 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…
Compounding 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…
Compounding 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…
Unused Medications: What Should I Do With Them?
While many consumers continue throw away medications in the trash or flush medications down the toilet, consumers…
California Seeks to Expand the Practice of Pharmacy
Earlier this month, California Governor Jerry Brown signed a new California law that seeks to expand the…
Compounding and Nonresident Pharmacies
In late 2012, an outbreak of fungal meningitis brought national attention to compounding pharmacies, the sterility and…