The refusal to provide comparator products violates federal and state antitrust laws and the CREATES Act. Although the Supreme Court has expressed caution about imposing antitrust liability based on a monopolist’s unilateral refusal to deal, the... Read More
Biotech Companies | Blogs & Articles | Life Sciences | Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

The Food and Drug Administration (FDA) issued emergency use authorization for three vaccines to protect against COVID-19.  While these long-awaited vaccines have provided tremendous hope for the nation in looking for a pathway out of the pandemic,... Read More
Blogs & Articles | Community, Retail Pharmacies | COVID-19 Resources | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

Thirty-seven years after enactment of the Hatch Waxman Act 2, it remains difficult for Congress, and the drug supply chain industry to strike the appropriate balance of legal rights between brand name and generic drug manufacturers as it relates to... Read More
Blogs & Articles | Intellectual Property Services | Life Sciences | Manufacturers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

Traditionally, generic drug companies have been able to obtain FDA approval for less than all of the FDA approved indications of a drug, a “carve out” commonly referred to as a “skinny label.” A safe harbor currently allows generic... Read More
Blogs & Articles | Life Sciences | Manufacturers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

Compounding pharmacies should be aware of recent developments in the law surrounding bioidentical hormone therapy (cBHT). In the field of pharmacy, compounding (performed in compounding pharmacies) is preparation of a custom formulation of a... Read More
Blogs & Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

HHS Permits Out-of-State Telehealth Providers to Render Certain Services Nationwide     On December 3, 2020, the Department of Health and Human Services (“HHS”) announced a fourth amendment to its declaration under the Public Readiness and... Read More
Blogs & Articles | COVID-19 Resources | Healthcare | Telehealth and Telemedicine

The FDA has delayed the verification of salable returns requirement under the Drug Supply Chain Security Act (DSCSA) until November 27, 2023. On October 22, 2020, FDA released a Guidance delaying enforcement of the provision that requires wholesale... Read More
Blogs & Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

A compounding pharmacy based in Kentucky, and its owner, admitted on October 29, 2020 in federal court to unlawful distribution of compounded prescription drugs.  The Pharmacy pleaded guilty to unlawful distribution of substances that the FDA had... Read More
Blogs & Articles | Life Sciences | Pharmacy Law | Traditional Compounding Pharmacies (503A) | White Collar Criminal Defense & Government Investigations