In an alarming trend, a manufacturer of diabetic test strip has taken actions against pharmacies alleging that they purchased the manufacturer’s test strips (the “Test Strips”) from unauthorized distributors or wholesalers.  The manufacturer... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Digital Pharmacies | Fertility Pharmacies | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Specialty Pharmacies | Supermarket Pharmacies

The Food and Drug Administration (“FDA”) regulates and categorizes human cell and tissue products (“HCT/Ps”) based on the public health risks they pose. HCT/Ps are biological products that are used to repair, replace or regenerate human... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Digital Pharmacies | Federal and State Fraud and Abuse Counseling | Fertility Pharmacies | Long-Term Care Pharmacies | National Board of Pharmacy Matters | Pharmaceutical Manufacturers | Regulatory Compliance, including FDA, DEA and HIPAA | Specialty Pharmacies | State Board of Pharmacy Hearings and Professional Discipline | Supermarket Pharmacies | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

Enacted on December 29, 2022, the  Modernization of Cosmetics Regulation Act ("MoCRA") applies more of a drug-like regulatory framework to cosmetics. The landmark legislation significantly overhauls the Food and Drug Administration’s (“FDA”)... Read More
Articles | Drug and Device Advertising, Marketing & Promotion Legal Review | Intellectual Property Services | Manufacturers | Pharmaceutical Manufacturers | Regulatory Compliance, including FDA, DEA and HIPAA

As previously discussed in our article in June 2022, the New York Department of Health (“NYDOH”) has taken the position that community pharmacies that have dual enrollment with Medicare as both a pharmacy provider (through CMS-855B enrollment)... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Section 340B In-House and Contract Pharmacies | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | Veterinary Compounders

There have been numerous legal and regulatory developments over the past year that pertain to 503A pharmacy compounding. In Part 1 of this two-part series, we discussed revisions to the United States Pharmacopeia’s (“USP”) guidelines for... Read More
Articles | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A) | Veterinary Compounders

There have been numerous legal and regulatory developments over the past year that pertain to 503A pharmacy compounding. In Part 1 of this two-part series, we explore the revisions to the United States Pharmacopeia’s (“USP”) <797> and... Read More
Articles | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A) | Veterinary Compounders

Compounding pharmacies should be Food and Drug Administration (“FDA”)-inspection ready and establish a plan to mitigate FDA inspection stress. As we approach the 10-year anniversary of passage of the Drug Quality and Security Act, the FDA... Read More
Articles | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A) | Veterinary Compounders