Compliance

Mastering the Master Service Agreement (MSA)

March 15, 2022

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…

Congress Begins Work on FDA User Fee Reauthorization Measure

February 16, 2022

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…

AAHP Submits Comments and Briefs Industry on New FDA Requirements

January 19, 2022

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.…

Supporting Your Success in 2021 and 2022

January 19, 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…

Quality Agreement Development and Importance

December 9, 2021

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…

Members Heads-Up on Two New Hot FDA Announcements

November 16, 2021

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…

Pharmaceutical Water: Standards, Purification, and Potential Problems

November 9, 2021

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,…

CMO Selection and Auditing for the Homeopathic Industry

November 8, 2021

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…

Are You Certain Your Homeopathic Attenuation Labeling is Correct?

November 8, 2021

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…

Supply Chain Management for Homeopathy, Part 1 of 4

October 15, 2021

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…

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