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Category: Regulatory Compliance, including FDA, DEA and HIPAA

, and October 6, 2020
On October 2, 2020, federal prosecutors in Massachusetts charged three individuals for their alleged role in a complex durable medical equipment (“DME”) marketing scheme. Of note, two of the three were also charged with criminal violations of... Read More
Healthcare | Regulatory Compliance, including FDA, DEA and HIPAA

and October 2, 2020
Frier Levitt has identified an alarming trend in government investigations of pharmacies whereby Office of Inspector General (“OIG”) and Drug Enforcement Administration (“DEA”) issue subpoenas simultaneously or almost at the same time. ... Read More
Blogs & Articles | Community, Retail Pharmacies | Life Sciences | Regulatory Compliance, including FDA, DEA and HIPAA

and May 12, 2020
In a continuing effort by various federal and state agencies to stop COVID-19 related frauds, the FDA has implemented “Operation Quack Hack.” As such, the FDA has issued close to 50 warning letters, and estimates that it will issue hundreds more... Read More
COVID-19 Resources | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Service | White Collar Criminal Defense & Government Investigations

and April 27, 2020
COVID-19 is having a profound effect on clinical trials for medical products, including drugs, devices and biological products. Site closures, travel restrictions, quarantines, infections among participants and trial personnel, and investigational... Read More
Blogs & Articles | COVID-19 Resources | Healthcare | Healthcare Law | Laboratories | Regulatory Compliance, including FDA, DEA and HIPAA

April 24, 2020
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

and April 23, 2020
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

April 20, 2020
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

and April 8, 2020
The Food and Drug Administration (FDA) has now issued three Guidance’s pertaining to processes and formulas for compounding of alcohol-based hand sanitizers during the COVID-19 public health emergency: Temporary Policy for Preparation of... Read More
Blogs & Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

and March 25, 2020
Outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act may use a bulk drug substance to compound a drug if: the Food and Drug Administration (FDA) has determined there is clinical need to compound with the... Read More
COVID-19 Resources | Life Sciences | Outsourcing Facilities (503B) | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA