article thumbnail

A Closer Look At Our On-Site Compounding Pharmacies

Alta Sciences

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Electronic security access to the pharmacy and video monitoring. -

article thumbnail

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Agency IQ

Requirements for 503A pharmacies have since been updated, most notably under the Drug Quality and Security Act ( DQSA ) of 2013, which established new requirements for 503A pharmacies as well as a new category of compounding pharmacies, known as outsourcing facilities (503B pharmacies). suppositories).

FDA 40
article thumbnail

Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

The Pharma Data

Goldman Sachs jumps aboard Bain-backed 503(b) compounding pharmacy with a $275M debt loan to supply hospitals ( Endpoints ). Quest Pharmaceuticals Loses In Opioid Liability Coverage Suit ( Law360 ). Quest Pharmaceuticals Loses In Opioid Liability Coverage Suit ( Law360 ).

Vaccine 52
article thumbnail

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

FDA 40
article thumbnail

Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

Agency IQ

The potential for Congress to overturn this dynamic could have major and negative effects on the drug’s current owner, Jazz Pharmaceuticals. For example, Epidiolex at present is effectively protected by provisions of DSHEA which limit the introduction of CBD as a legally regulated product due to its status as an approved drug.