Baer Law Blog - Latest Updates
The Push for Bilingual Prescription Labels in California
The California Board of Pharmacy (Board), which regulates approximately 6,500 community pharmacies and 500 hospital pharmacies statewide,…
Corresponding Responsibility: A Pharmacist's Obligation to Understand
Why is understanding corresponding responsibility important to me as a practicing pharmacist? In short, enforcement actions against pharmacies…
FedEx and Online Pharmacy Issues
The blitz against online pharmacies was launched in 2005 and has resulted in dozens of arrests, thousands…
Biosimilar and Interchangeable Products: Massachusetts Enacts New Law
Biosimilar drugs are biological drugs that are similar but not identical to a referenced biological or branded…
Compounded Drugs and Medicare Part B
Medicare Part B generally covers most medically necessary doctors’ services. These services can include some limited outpatient…
Outsourcing Facilities: Section 503B
The Drug Quality and Security Act (DQSA) can be separated into two sections: Title I addresses drug…
Compounding: Section 503A Changes
The regulatory landscape for pharmacy compounding has changed immensely since the passage of the Drug Quality and…
Enhancing FDA Communications: DQSA Update
The Food and Drug Administration (FDA) was granted some new authority this week by the Department of…
Drug Quality and Security Act: Title II – Track and Trace System
The Drug Quality and Security Act (DQSA) was designed to clarify the Food And Drug Administration’s (FDA)…
Drug Quality and Security Act: Title I – Compounding
On November 23, 2013, the President signed the Drug Quality and Security Act (DQSA) into law. As…