Frier Levitt is happy to announce a successful result on behalf of an urgent care center client in a county-based Department of Health (“DOH”) Hearing matter. The urgent care center was facing significant civil penalties of over $30,000 for... Read More
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
"In the second part of our series on 503A compounding, we review the current state of compounding certain drugs that are on the shortage list, compounding “essentially a copy,” as well as compounding peptides, DTE, semaglutide, β lactams,... Read More
Pharmacy compounding is a vital aspect of pharmacy practice, playing a crucial role in healthcare provision. However, there have been several recent legal and regulatory developments regarding 503A pharmacy compounding, presenting both opportunities... Read More
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
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
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
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
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
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
