Compliance
Mastering the Master Service Agreement (MSA)
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…
Read MoreCongress Begins Work on FDA User Fee Reauthorization Measure
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…
Read MoreAAHP Submits Comments and Briefs Industry on New FDA Requirements
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.…
Read MoreSupporting Your Success in 2021 and 2022
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…
Read MoreQuality Agreement Development and Importance
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…
Read MoreMembers Heads-Up on Two New Hot FDA Announcements
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…
Read MorePharmaceutical Water: Standards, Purification, and Potential Problems
By Tim Clarot, Industry Consultant Water is vitally important for all living things and is found everywhere on earth—from the polar ice caps to steamy geysers. Wherever water flows,…
Read MoreCMO Selection and Auditing for the Homeopathic Industry
Supply Chain Management for Homeopathy, Part 2 of 4 By Tim Clarot, Industry Consultant In part one, we introduced the concept of the supply chain as part of a…
Read MoreAre You Certain Your Homeopathic Attenuation Labeling is Correct?
By Eric Foxman, Pharm., AAHP Secretary FDA noted some concerns that homeopathic drug products may not always be labeled to clearly indicate whether homeopathic attenuations have been made using…
Read MoreSupply Chain Management for Homeopathy, Part 1 of 4
By Tim Clarot, Industry Consultant Empty shelves in supermarkets, cars selling at above list price, and a critical shortage of shipping containers are some of the visible effects of a…
Read More