In an effort to facilitate continuity of patient care and to respond appropriately to the circumstances that have arisen during the COVID-19 pandemic, the Drug Enforcement Administration (“DEA”) has recently announced three exceptions to DEA... Read More
Blogs & Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Life Sciences | Pharmacy Law | Physician Dispensing | Regulatory Compliance, including FDA, DEA and HIPAA | Specialty 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

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

As Coronavirus (COVID-19) cases continue to plateau and as the nation experiences the benefit of social distancing, the focus has quickly turned to the development of a vaccine.  Promising Vaccines Despite the substantial cost of developing,... Read More
Blogs & Articles | COVID-19 Resources | Healthcare Law | Life Sciences | Manufacturers | Pharmacy Law

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 | Life Sciences | Manufacturers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

U.S. Attorneys in the Southern District of Georgia recently charged the operator of a durable medical equipment company with conspiring to pay kickbacks to physicians in exchange for obtaining DME orders. This action reaffirms the Department of... Read More
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Frier Levitt is pleased to announce that its COVID-19 Task Force assisted a national distributor to obtain an authorized distributorship of COVID-19 testing kits from a renowned South Korean manufacturer. This is a crucial development amid the... Read More
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Pharmacists are frequently the first point of contact with a healthcare provider for many Americans. In an effort to implement large-scale testing for COVID-19, on April 8, 2020, the Office of the Assistant Secretary of Health, HHS, authorized... Read More
Blogs & Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Healthcare | Laboratories | Life Sciences | Pharmacy Law | Specialty Pharmacies