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 | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Section 340B In-House and Contract Pharmacies

In a March 30th, 2020 proposed Interim Final Rule (“IFR”), CMS declared that it would be applying (and, later, expanding the scope of) its “extreme and uncontrollable circumstances” regulation, 42 C.F.R. 425.502(f), to “mitigate any impact... Read More
Blogs & Articles | COVID-19 Resources | Healthcare Law | Healthcare Litigation | Value Based Care

Wholesale drug distributors need to maintain adequate track and trace documents, especially when acquiring and distributing COVID-19 therapies. The COVID-19 epidemic has sparked a demand for various drug products including, hydroxychloroquine. To... Read More
Blogs & Articles | COVID-19 Resources | Manufacturers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

In the wake of the novel Coronavirus outbreak (COVID-19), hospitals and various other healthcare organizations right down to states and municipalities are scrambling to maintain sufficient inventory of Personal Protective Equipment (PPE) for their... Read More
Blogs & Articles | COVID-19 Resources | Healthcare | Healthcare Law | Healthcare Litigation | Hospitals and Healthcare Systems | Pharmacy Law