Compounding

Health Law Alliance adds powerhouse Pharmacist/Attorney Dr. Martha Rumore to their team of boutique healthcare attorneys.

FDA ramps up enforcement on GLP-1s, peptides, RUO labeling, and compounding practices. See how 503A and 503B facilities are affected.

FDA issued a Warning Letter to Darmerica citing cGMP violations and improper distribution of GLP-1 and peptide APIs. Learn what this means for 503A compounding pharmacies and supply chain compliance.

The DEA is increasingly targeting ketamine providers with record-keeping inspections and audits, making expert Medicare and DEA compliance defense essential to avoid steep fines and license risks.

The top Pharmacy Benefit Managers (PBMs) are condemned by the FTC for manipulating the healthcare system to generate significant profits, thereby inflating drug costs and overcharging patients, particularly for critical medications like cancer drugs.

Ozempic, a well-known medication for type 2 diabetes, has gained popularity for its off-label use in weight loss, leading to increased scrutiny by authorities. Recently, U.S. Customs and Border Protection (CBP) officers in Cincinnati seized several shipments of the drug, underscoring the growing demand and associated risks.

There has never been a more fortunate time for compounding pharmacies looking to capitalize on the "Gold Rush" of Ozempic. Due to the forecasted limited supply of the brand name drug, the FDA has put Ozempic on the shortage list, which will allow for a more accommodating set of rules regarding compounding and distribution of semaglutide-based drugs.

As summer approaches, soaring demand for weight-loss drugs like Ozempic, Wegovy, and semaglutide compounded copies, will exacerbate the existing short-supply, raising both consumer prices and pharmacy profits for those positioned to capitalize.

Semaglutide compounding pharmacies face regulatory threats as state boards interpret statutes restrictively; Health Law Alliance, led by Anthony Mahajan, emphasizes broader permissions, countering misinterpretations.