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of two years after the enactment of the 2013 Drug Supply Chain Security Act (“DSCSA”), FDA has finally published a draft guidance document on waivers, exceptions, and exemptions (“WEE”) from certain requirements of FDCA Section 582.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 …
After President Obama signed into law Title I of the Drug Quality and Security Act (the Compounding Quality Act), which created a new breed of drug compounders (deemed “outsourcing facilities”), FDA also came up with a plan to evaluate bulk substances outsourcing facilities could use …
As stated in our post last week, on February 28, 2018, Commissioner Gottlieb announced FDA’s release of a draft guidance document addressing certain requirements under the 2013 Drug Supply Chain Security Act (DSCSA) concerning standardization of data and documentation practices for product tracing. The purpose …
On February 28, 2018, Commissioner Gottlieb announced FDA’s release of two draft guidance documents addressing certain requirements under the 2013 Drug Supply Chain Security Act (DSCSA), concerning standardization of data and documentation practices for product tracing (here), and definitions of suspect and illegitimate products (here). …
Today the PEW Charitable Trusts released a detailed report on the general state of pharmacy compounding of human drug products in the United States. The Report focuses on compounding pharmacies, but addresses both sterile and non-sterile compounding regulation by states. The Report also touches on …
As stated in our blogpost discussing FDA’s announcement of 2018 Compounding Policy Priorities (here). FDA also released its Final Guidance on Compounding “essentially copies” of commercially available drugs. This long-anticipated guidance discusses how FDA intends to determine whether a compounded drug is essentially a copy …
Last week FDA announced the release of its 2018 “Compounding Priorities Plan.” FDA also released several guidance documents in the wake of its announcement, such as its final guidance on essentially copies of commercially available drug products for Section 503A and 503B facilities (more on …
Although the Drug Supply Chain Security Act of 2013 (DSCSA) required publication by 2015 of guidance addressing grandfathering of certain product identifier requirements for packages or homogeneous cases of finished dosage form prescription drugs, “its better late than never,” as the saying goes. On Monday …
On October 26, 2017, Par Sterile Products, LLC and Endo Par Innovation Company filed a Complaint in the United States District Court for the District of Columbia against the Food and Drug Administration. At the heart of the Complaint is FDA’s Interim Policy addressing compounding …
We have witnessed this past week some noteworthy activity in the drug compounding space. Where will this lead traditional compounders and outsourcing facilities? What will it mean for compounders in the months ahead? We will just have to wait until FDA releases anticipated draft guidance …
In the almost four years since passage of Title I of the Drug Quality Security Act, (the Compounding Quality Act), FDA has inspected hundreds of pharmacies, issued numerous Form 483s and warning letters, and has requested both voluntary recalls and cessation of non-sterile and sterile …
In likely the first time since the United States Court of Appeals for the Fifth Circuit decided Medical Center Pharmacy v. Mukasey, 536 F.3d 385 (5th Cir. 2008) (see our previous post here), a federal court located in the Western District of Louisiana (within the …
The FDA just released Draft Guidance affecting the implementation of the Drug Quality and Security Act’s (DQSA) November 27, 2017 “serialization” requirements for finished dosage form pharmaceutical prescription drug products (as defined by the DQSA). Among addressing other issues, the newly released Draft Guidance states …
A recent letter from 65 members of Congress to FDA’s Commissioner Gottlieb has caused a bit of a buzz in the pharmacy compounding world. The letter, dated May 23, 2017, expresses the Congressional signers’ “strong disappointment” with FDA’s recently issued Final Guidance for Industry titled, …
