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

November 12,  2019

FDA’s denial of industry petition to retain 1988 Compliance Policy Guide concerning homeopathic remedies signals new risk-based regulation and enforcement actions

In an October 30 review, authors at Venable LLP note that until 2019, FDA’s regulation of homeopathic remedies was governed by Compliance Policy Guide (CPG) §400.400, which generally restricted enforcement actions to mislabeled products or products not manufactured in compliance with GMP regulations. In 2017, the agency issued a draft guidance which would replace the CPG and which set forth a “risk-based” model of enforcement.

An industry group, Americans for Homeopathy Choice, petitioned the FDA to retain the 1988 CPG, and on October 24, FDA denied the petition.  [USDHHS, FDA. Petition response letter from FDA CDER to Americans for Homeopathy Choice, 2019 Oct 24;] Among other bases, the agency cited recent experience demonstrating that homeopathic drugs are not universally safe: 99 cases of belladonna toxicity (including infant deaths and seizures) and over 130 reports of anosmia associated with Zicam® (homeopathic intranasal zinc) products. SS

The 2019 draft guidance is available for comment through December 24, 2019 [USDHHS, FDA. Drug products labeled as homeopathic: Draft guidance for Food and Drug Administration Staff and Industry, 84 Fed. Reg. 57441, October 25, 2019]

As summarized by Venable LLP, FDA will take enforcement actions concerning:

  • Products with reports of injury that, after evaluation, raise safety concerns
  • Products that contain or purport to contain ingredients associated with potentially significant safety concerns
  • Products for routes of administration other than oral and topical (e.g., ophthalmic or injectable)
  • Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions
  • Products for vulnerable populations (e.g., children, the elderly, pregnant women, or immunocompromised individuals)
  • Products with significant quality issues

The authors note that the guidance reaffirms “that homeopathic drug products do not have any special status under federal law.” Thus, they conclude, “the agency is essentially saying that all homeopathic drug products that are not marketed under an approved new drug application (i.e., all homeopathic drug products) are unlawful. This could embolden the plaintiff bar to initiate lawsuits against all companies selling homeopathic products – even those that survive the increased scrutiny of this new FDA enforcement policy.” [Harrison TA, Lewis CA, Halpern TH. FDA & homeopathy: the end of diluted enforcement? Venable LLP Insights, 2019 Oct 30;]