Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
| Endo Agrees To Pause Lawsuit After FDA Promises New Bulks Guidance
Endo Pharmaceuticals has agreed to a temporary stay of its lawsuit against FDA over the agency's interim policy on compounding using bulk substances until the agency releases new guidance to significantly rework the controversial policy. As Inside Health Policy previously reported, Endo sued FDA in ...
|
| FDA Continues to Prioritize Compounding Regulation with the 2018Compounding Policy Priorities ...
A component of the Federal Food, Drug and Cosmetic Act (FD&C Act) is the restrictions it places on compounding drugs that are essentially copies of FDA-approved or commercially available products. On January 19, 2018, FDA issued two final guidance documents regarding the copies provisions for ...
|
| New Bulk Substance Compounding Guidance Coming In 2018
In the wake of a controversial policy that ended up getting the agency sued, FDA announced it will release new guidance in March on determining the clinical need to warrant compounding using bulk substances, which one source familiar with the drafting and negotiations around the compounding la
|