A drug pricing program authorized under a 1992 amendment to the Public Health Service Act (Pub. L. 102-585 (1992); 42 U.S.C. § 256b), named 340B, requires drug manufacturers, in exchange for having its drugs covered by Medicaid, to sell outpatient... Read More
Blogs & Articles | Community, Retail Pharmacies | Life Sciences | Section 340B In-House and Contract Pharmacies

Over the last few days, FDA has issued several guidance documents relating to compounding of certain aqueous injectable drugs by outsourcing facilities, State-licensed pharmacies and Federal facilities for duration of the COVID-19 public health... Read More
Blogs & Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Healthcare | Hospitals and Healthcare Systems | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Section 340B In-House and Contract Pharmacies

Ohio legislators have introduced bipartisan Senate and House bills aimed at curbing excessive fees charged by insurers and Pharmacy Benefit Managers to pharmacies and providers participating in the 340B Drug Pricing Program. The 340B Program,... Read More
Defending Pharmacies in PBM Audits | DIR Fees | Pharmacy Law | Section 340B In-House and Contract Pharmacies

The impact of Direct and Indirect Remuneration ("DIR") fees on the specialty pharmacy industry cannot be overstated and has been widely reported in White Papers and industry news reports. However, the impact of DIR fees on the 340B sector is only... Read More
Blogs & Articles | Defending Pharmacies in PBM Audits | DIR Fees | Pharmacy Law | Section 340B In-House and Contract Pharmacies