Compliance

By Al Lorman, AAHP Counsel Pharmacopoeias have been around for thousands of years. Historically, they provided the medical community with critical information necessary to make (and sometimes use) drugs. In many ways, pharmacopoeias were the first consumer protection vehicle in the world of pharmaceuticals. The Homeopathic Pharmacopoeia of the United States (in its various iterations)…

By Eric Foxman, Pharm. (Ret.), AAHP Secretary The Homeopathic Pharmacopoeia Convention of the United States held its annual meeting in the latter half of April. This included both the Board and general membership meetings. Many of the working committees also held meetings within the same time frame. For the third consecutive year, all were hosted…

By Mark Land, AAHP President The first edition of the Homeopathic Pharmacopoeia of the United States (HPUS) was first published in 1897 – 125 years ago! Since FDA’s 2019 draft guidance defines a homeopathic drug product as one labeled as homeopathic and containing active ingredients and dilutions referenced within the HPUS, it’s more crucial than…

By Eric Foxman, Pharm. (Ret.), AAHP Secretary | What is the process through which the Homeopathic Pharmacopeia Convention of the United States (HPCUS) revises monographs? What role can subscribers and non-members play in this activity?

Supply Chain Management for Homeopathy, Part 4 of 4 By Tim Clarot, Industry Consultant The final element of a good supply chain structure is the Master Service Agreement. The MSA is a contract between the responsible parties describing the terms and conditions of the relationship. It is primarily a financial document; however, it should also…

By Mark Land, AAHP President This year marks the 30th anniversary of the enactment of the Prescription Drug User Fee Act (PDUFA). Enacted in 1992, PDUFA authorized FDA to collect user fees from companies that submit applications for human drug products. Congress has since passed additional legislation allowing FDA to collect user fees from makers…

In November 2021, FDA announced a guidance regarding annual reporting of quantities of drugs manufactured or compounded. The deadline for the first reports, covering quantities produced in 2020, is Feb. 15. The comment period regarding this guidance document ended earlier this month. The AAHP filed comments along with other organizations. Your association’s submission supported the…

By Mark Land, AAHP President As challenges continue into 2022, so will opportunities. COVID-19 heightened the awareness and value of many OTC and self-care products, including homeopathic medicines, as consumers endeavored to shake-off common treatable conditions and keep their immune system high. As the importance of maintaining access to homeopathic OTCs during the past two…

Supply Chain Management for Homeopathy, Part 3 of 4 By Tim Clarot, Industry Consultant   This third article in the supply chain management series will cover the development of a product owner-CMO Quality Agreement (QA) document. Beyond the regulatory requirement of having a documented Quality Agreement in-place, the creation of the document gives the owner…

By Mark Land, AAHP President Recently members received a special e-blast alerting them of two important FDA announcements. While members can read more on a password protected webpage as a member benefit, it is worth briefly summarizing the announcements for all our readers to keep our industry compliant. First, FDA distributed a public service announcement…