The American Society for Pharmacy Law (ASPL) is an organization of attorneys, pharmacists, pharmacist-attorneys and students of pharmacy or law who are interested in the law as it applies to pharmacy, pharmacists, wholesalers, manufacturers, state and federal government and other interested parties.

ASPL is a nonprofit organization with the purposes of

  • Furthering knowledge in the law related to pharmacists, pharmacies, the provision of pharmaceutical care, the manufacturing and distribution of drugs, and other food, drug, and medical device policy issues;
  • Communicating accurate legal educational information; and
  • Providing educational opportunities for pharmacists, attorneys, and others who are interested in pharmacy law

ASPL has become the premier source to engage with the entire spectrum of professionals at the intersection of pharmacy and legal matters. With my formal training, I approach our meetings with the assumption that I have grasped all of the components that contribute to the pharmacy profession. However, engaging with ASPL has placed context around the various, often overlooked, downstream and upstream factors that impact the law as it applies to pharmacy.
Monet Stanford, PharmD

Latest News

September 16,  2019

COMPOUNDING

FDA issues statement on adverse event reporting for compounded drugs
On September 9, CDER Director Janet Woodcock issued a statement about the need for outsourcing facilities to collect and report adverse event. It refers interested parties to a publication in JAMA Internal Medicine that detailed 4,202 AERs related to compounded hormone pellets that had been collected by BioTE Medical (BioTE) but never reported to the FDA. These reports were discovered during a routine inspection and “concerned the possible association of compounded hormone pellets ... with cancers (including endometrial and prostate cancers), strokes, heart attacks, deep vein thrombosis, cellulitis, and pellet extrusions, as well as adverse events known to be caused by supratherapeutic hormone concentrations.” [Dohm J, Kim, J, Woodcock J. Improving adverse event reporting for compounded drugs. JAMA Intern Med., published online Sept. 9, 2019. Doi:10.1001/jamainternmed.2019.3830]

The drugs in question were compounded by Carie Boyd’s Prescription Shop and AnazaoHealth Corporation, both registered outsourcing facilities, but were marketed by BioTE Medical, which was not registered. BioTE had an online portal to collect the reports, and dis so between 2013 and 2018, but never reported them to the FDA. Because FDA is still investigating the matter, Dr. Woodcock’s statement declined to provide further comment. However, the statement noted that “Outsourcing facilities are subject to regulatory and enforcement action if they do not appropriately label their drugs with adverse event reporting information and to report events to the FDA. The agency intends to take appropriate action if outsourcing facilities do not comply with the adverse event reporting requirements. We remind outsourcing facilities to compile and investigate adverse event reports and share them with FDA.”

The agency is using this incident to spur “steps to improve adverse event reporting and analyses,” and will continue to develop an MOA with state partners. A study by the National Academy of Sciences, Engineering and Medicine has been established that will evaluate the “risks associated with compounded hormone products.” The statement notes that [Woodcock J. Statement on improving adverse event reporting of compounded drugs to protect patients. USDHHS, FDA, 2019 Sep 9; http://bit.ly/301jSKm]

In a comment on the Woodcock statement, the FDA Law Blog concluded with several questions: “Is FDA telegraphing that it will take some form of action against outsourcing facilities that allegedly provided the compounded formulations ... for failure to appropriately label a compounded formulation? Were the formulations at issue actually improperly ‘labeled’? Whose name(s) were on the label and did the label warn about adverse events, including reporting instructions? What about Congress’ prohibitions ... against wholesaling and transfer of a drug product ...? What happened here? ... Were the compounded formulations transferred or resold ...? So many questions.... We will stay tuned as FDA’s investigation – which FDA has generally chosen to cast into a cautionary public tale, with little specifics revealed – moves forward.” [Palmer KL. Compounded hormone replacement products: FDA latest “Statement” (?) addressing adverse event reporting. FDA Law Blog 2019 Sep 16; http://bit.ly/31v9Y0M]