See what we did there? Well, readers, some big things have taken place. “Big things” have happened: we previewed these for you in our two-part FDA’s Pep(tide) Rally! What Compounders and Industry Need to Know blog posts (Part I, Part II). Yesterday, on Day 1 of FDA’s …
We have covered a lot of ground on this blog over the years: Hatch-Waxman disputes, REMS programs, and everything in between. Rarely have we had occasion to write a sentence like this one: A podcast host texted the President of the United States about a …
As promised and teased in yesterday’s blog post, we discuss other practical implications of and compliance concerns surrounding the ongoing shift in peptide policy below. Supply Chain Complications There is also a supply chain issue that sits upstream of any FDA regulatory authorization of their use in …
The peptide compounding landscape shifted last week, and if you are interested or involved in the peptide industry, compounding pharmacies, telehealth, or the broader market for injectable wellness products, you’ll want to understand what happened—and perhaps more importantly, what hasn’t happened yet. FDA’s PCAC Meeting Announcement We …
FDA has published its long awaited Final Rule Revising the National Drug Code Format and Drug Label Barcode Requirements which will expand the dwindling supply of FDA labeler codes and corresponding NDCs to what FDA states is a 900-year supply. As a reminder, NDCs are …
One year ago, we blogged on a DEA decision revoking the registration of a Louisiana pharmacy, Neumann’s Pharmacy, LLC, based on the pharmacy’s purported violation of its “corresponding responsibility” (21 C.F.R. § 1306.04(a)) and filling of prescriptions without resolving so-called “red flags” of diversion. The …
Are compounders on notice? FDA may be coming for at least one of them, with a little help from its friends at the Justice Department. On the heels of the Novo Nordisk’s Wegovy® pill launch, Hims & Hers, in a headscratcher of a promotional move, doubled …
On September 11, 2025, Reps. Diana Harshbarger (R-TN) and Buddy Carter (R-GA)—the only two pharmacists in the U.S. House of Representatives—introduced a new bill, titled “Drug Shortage Compounding Patient Access Act” (H.R. 5316), that would expand the ability of compounding pharmacies and outsourcing facilities to …
Earlier this week, we posted on the retirement of DEA Chief Administrative Law Judge Judge John J. Mulrooney, II, and the lack of appointed DEA ALJs to hear DEA cases upon his retirement, effective August 1. On a related note, HPM wants to take a …
Last week, DEA registrants and applicants with pending actions before DEA’s Office of Administrative Law Judges (OALJ) received an order from Chief Administrative Law Judge John J. Mulrooney, II, staying the hearing proceedings in those cases. In those orders, Chief Judge Mulrooney announced that he …
In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. The federal telemedicine flexibilities (i.e., temporary exceptions from some of the …
As we reported back in January, Phibro Animal Health Corporation challenged FDA’s decision to remove a drug called carbadox—used as an antimicrobial drug to treat gastrointestinal disease in food-producing pigs—from the market. More specifically, FDA rescinded approval of a “regulatory method” that Phibro used to …
For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. The CSA and regulations promulgated by DEA are …
A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). We blogged about CVM last week and explained the increasing attention to animal health products due to the expansion of the animal …
Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. With the growth in pet ownership, the pet health product market has also exploded; a …
