FDA published a statement on September 9, 2019, linking to an article by Janet Woodcock and others concerning reporting of adverse events involving compounded bioidentical hormone replacement therapy (BHRT) products, including ingredients such as progesterone and testosterone. FDA states there were over 4,200 adverse events …
On September 5, 2019, FDA published its proposal to amend its Section 503A bulk substances regulation, 21 C.F.R. § 216.23, to add five bulk drug substances that FDA considered to the Section 503A Bulks List, and not to add 26 substances. Prior to this latest …
After the D.C. District Court released its decision, blogged about here, affirming FDA’s revised bulks nomination process and FDA’s removal of vasopressin from the Section 503B bulks list, FDA touted the court’s favorable decision in a press release here. Still basking in the wake of …
In a much-anticipated decision for those that have been following the saga of whether FDA has appropriately set the test for determining how it may include bulk substances on its list of substances that may be used in compounding under Section 503B of the Federal …
The U.S. Food and Drug Administration (FDA) recently issued a guidance document that intends to “help small businesses better understand and comply” with the Agency’s Section 503A bulk substances final rule, issued February 19, 2019. The final rule establishes FDA’s criteria for evaluating nominated bulk …
We posted last year about the dispute over FDA’s determination to include certain nominated substances on its Bulk Substances List 1 for Section 503B outsourcing facilities. Recall that in 2017, after FDA approved Endo/Par’s Vasostrict® finished drug product, several entities nominated active pharmaceutical ingredient vasopressin …
On Monday, March 4, 2019, FDA released its Final Guidance , titled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” We blogged about FDA’s draft guidance here, which FDA published about a …
On Tuesday, February 19, 2019, FDA released its first Final Rule (of many likely to follow…) identifying six substances that FDA has determined are appropriate for use in compounding by Section 503A pharmacies. The Final Rule relates back to FDA’s 2016 Proposed Rule nominating certain …
The United States Department of Justice (“DOJ”) announced on February 8, 2019, the use of a new weapon in its enforcement arsenal to help manage the opioid crisis. It involved a coordinated effort including DOJ’s Prescription Interdiction & Litigation (“PIL”) Task Force, which deploys all …
Late last month, FDA published revised draft guidance, titled “Insanitary Conditions at Compounding Facilities: Guidance for Industry.” The revised guidance comes two years after FDA released its August 2016 draft guidance addressing what it considers “insanitary conditions” during inspections of both Section 503A pharmacies and Section …
FDA’s Commissioner Scott Gottlieb, M.D., announced last Friday, September 7, 2018, FDA’s publication of its revised draft Memorandum of Understanding (“MOU”) between states and FDA addressing interstate shipment of compounded medications. This is the third draft MOU published by FDA that involves interstate shipment of …
For regular readers of compounding news on our FDA Lawb Bog, the “bulks” saga for outsourcing facilities continues with a whirlwind of activity. A bit of background: FDA published a new bulk substances list for Section 503B outsourcing facilities on July 23, 2018, where vasopressin somewhat …
On August 13, 2018, Buffalo, New York-based Athenex Pharma Solutions, LLC and Athenex Pharmaceutical Division, LLC (Athenex) announced the launch of their vasopressin compounded formulation injection ready-to-use product line (see Press Release here). It also moved to intervene (either as of right or permissively) in …
Monday was a big day for those monitoring whether and when FDA will add certain previously nominated bulk substances to its various “Bulks Lists” for Section 503A pharmacies and Section 503B outsourcing facilities. As previously blogged about here, back on March 23, 2018, FDA announced …
Notwithstanding a statutory deadline of two years after the enactment of the 2013 Drug Supply Chain Security Act (“DSCSA”), FDA has finally published a draft guidance document on waivers, exceptions, and exemptions (“WEE”) from certain requirements of FDCA Section 582. Since late November 2013, the pharmaceutical …
