Regulatory/Legislation

Understanding OTC Monograph Reform: Where Do We Stand Now?

June 27, 2016

By J.P. Borneman, Ph.D. and Alvin J. Lorman, J.D. The FDA’s Over-the-Counter Drug Review (OTC Review) has always been important to homeopathy, despite the fact that homeopathic drugs are not directly subject to the review. FDA specifically excluded them in 1972, stating that it would review them separately at the conclusion of the allopathic OTC…

FDA Guidance for Industry – Request for Quality Metrics

June 2, 2016

By Mark Land, AAHP President FDA published its draft guidance, Request for Quality Metrics; Guidance for Industry1. Advancing the background on the initiative in general, this draft reveals 10 mandatory metrics emanating from manufacturing and laboratory systems. It also requests comments on three optional metrics: 1) senior management engagement, 2) the corrective and preventative actions…

Educational Webinar Resources Available

June 25, 2019

Missed an education opportunity? Need materials for your mandated employee training? You have a second chance! AAHP webinars can help fulfill your required mandatory staff training requirements. Homeopathic manufacturers and marketers have found AAHP to be an excellent third-party source for this training.   All DVD’s include an MP4 recording of the webinar, an MP3…

AAHP Encourages Clear and Open Communication on Teething Medicines Tragedies

October 19, 2016

In the interest of public safety, the American Association of Homeopathic Pharmacists (AAHP) encourages the U.S. Food and Drug Administration to provide clear and open communication on their ongoing investigation of the safety of homeopathic teething medicine. Representing the manufacturers, distributors and marketers of homeopathic drugs, AAHP secretary Eric Foxman said industry leaders were surprised…

Consideration of Homeopathic Medicine as a Vaccine Alternative

December 10, 2015

 Milwaukie, Ore., Autumn 2015—As the public debate on vaccinations rises, more healthcare providers and parents alike seek information. The American Association Homeopathic Pharmacists (AAHP) reminds manufacturers and marketers that the promotion of any product—homeopathic or otherwise—as an over-the-counter alternative to a vaccine is a violation of federal and state law. Furthermore, in a letter to the Homeopathic…

Experts Discuss Advertising of Homeopathic Medicines at FTC Workshop

December 10, 2015

Washington, D.C., Sept. 22, 2015—Trade association leaders, experts in consumer marketing and regulations, and top physicians came together on Monday, September 21 in Washington, D.C. at “Homeopathic Medicine & Advertising: A Federal Trade Commission (FTC) Workshop.” President of the American Association of Homeopathic Pharmacists (AAHP) Mark Land stated, “We have a remarkable story to share…

Homeopathic Industry Proposes More Broad Use of Disclosures to FTC as the Path Forward

September 22, 2015

Industry leaders provide perspective on partnership opportunities for Federal Trade Commission Washington, D.C., Sept. 21, 2015— To better help consumers make informed choices, the American Association of Homeopathic Pharmacists (AAHP) proposed strengthening product label and advertising disclosures to the Federal Trade Commission (FTC) today in Washington, D.C. at the agency’s “Homeopathic Medicine & Advertising” workshop.…

The Homeopathic Industry Needs YOUR Support

August 3, 2015

Over the past few decades, the homeopathic industry has grown into a multibillion-dollar industry and national drug stores are finally recognizing the merits of our product. But as the industry has grown, so, too, has skepticism from legislators and regulators. While we successfully argued for the effectiveness of current regulations at a FDA hearing a few months…

AAHP Addresses OTC Homeopathic Drug Products for Asthma

March 30, 2015

The American Association of Homeopathic Pharmacists (AAHP), representing the principal manufacturers and distributors of homeopathic medicines in the United States, said today it fully supports the Food and Drug Administration’s position that consumers should seek the advice of their health care provider if they suspect they or their children are experiencing symptoms of asthma, which…

FDA’s Quality Metrics Initiative – From Compliance to Performance

February 17, 2015

By Mark Land, VP Operations and Regulatory Affairs at Boiron The 2012 Food Drug Administration Safety and Innovation Act (FDASIA) gave FDA new tools to encourage high quality manufacturing of pharmaceuticals and enhanced the agency’s ability to respond to, prevent and mitigate the risk of drug shortages. Section 705 of the Act specifically requires FDA…

AAHP monitors and reports on current federal regulations, legislation and government policies that affect the homeopathic community. AAHP is often the first to learn of regulatory changes that have both direct and indirect effects on our industry enabling members to stay ahead of the curve in a rapidly changing healthcare environment.

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