Medical spas are regulated by a patchwork of state rules and regulations usually governed by a medical board. In addition to standards and protocols regarding delegation/supervision of non-physicians such as physician-assistants, nurse practitioners... Read More
Frier Levitt successfully reversed findings issued by the State Department of Health against a South Carolina-based pharmacy. After an audit, the State asserted allegations of controlled substance record-keeping violations against the pharmacy.... Read More
Frier Levitt succeeded in obtaining a complete reversal of audit findings for a Florida home infusion pharmacy where the PBM alleged close to $750,000 in discrepancies associated with approximately 50 different claims. The audit discrepancies... Read More
Recently, Frier Levitt successfully represented a community pharmacy located in New Jersey facing an investigation stemming from a patient complaint. More specifically, a patient had submitted a complaint to the Board of Pharmacy regarding the... Read More
On August 25, 2023, the FDA issued a Guidance providing for a one-year enforcement discretion period for the Drug Supply Chain Security Act (DSCSA) requirement of electronic interoperability for tracking transactions. The delay was actively sought... Read More
In 2022-2023, more than 20 states proposed legislation to reign in White Bagging and/or Site of Service policies. These policies, which have been steadily increasing over the past few years, encompass more payors and medications. Notably, Florida is... Read More
On June 27, 2023, the FDA issued its long-awaited draft guidance on activities it considers wholesaling and those that it does not in the context of Section 503B’s prohibition on wholesaling of products compounded by outsourcing facilities. Once... Read More
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
