On June 27, 2023, the FDA issued its long-awaited draft guidance on activities it considers wholesaling and those that it does not in the context of Section 503B’s prohibition on wholesaling of products compounded by outsourcing facilities. Once... Read More
Articles | Life Sciences | Outsourcing Facilities (503B) | Pharmacy Law

In an effort to gain market access for new drugs and to shift the conversation from one of “volume” to one of “value,” pharmaceutical manufacturers are increasingly offering and agreeing to alternative payment models that set the price of a... Read More
Articles | Biotech Companies | Manufacturers | Pharmaceutical Manufacturers | Value Based Care | Value Based Care

In today’s ever-changing digital age, more and more human processes are being replaced by computers, with pre-coded algorithms, and now, through artificial intelligence.  These same advancements that have created tools across multiple industries... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | Fertility Pharmacies | Home Infusion Providers | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Outsourcing Facilities (503B) | Section 340B In-House and Contract Pharmacies | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | Veterinary Compounders

There have been numerous legal and regulatory developments over the past year that pertain to 503A pharmacy compounding. In Part 1 of this two-part series, we discussed revisions to the United States Pharmacopeia’s (“USP”) guidelines for... Read More
Articles | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A) | Veterinary Compounders