Regulatory/Legislation

Regulatory/Legislation

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.

Congress to Tackle “Must Pass” FDA Legislation Next Year

The Prescription Drug User Fee Act (PDUFA) authorizes the Food and DrugAdministration (FDA) to collect fees from Rx pharmaceutical companies to help fund the agency’s drug review work, hire FDA staff, and improve systems. The end goal of this user fee collection system is more timely approval of human drug applications. The regulated industry supportsRead More >

What About Your APIs and Q7 Requirements?

By Eric L. Foxman, R.Ph. Jan. 26, 2017 In September 2016, the U.S. Food and Drug Administration (FDA) issued a guidance document, entitled Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients—Guidance for Industry. The document applies to the manufacture of Active Pharmaceutical Ingredients (APIs) for use in human drug products and closely follows aRead More >

Regulatory Policy Analysis

A Tool for Evaluating the  Regulatory Framework for Homeopathic Drug Products By Mark Land, AAHP President Today the combination of drug regulations, approval options, cost controls and societal health care goals yield outcomes that are no longer obvious or predictable. So complex is the process that the field of regulatory science emerged to address theRead More >

Who Regulates Your Product Labels?

Does the U.S. Food and Drug Administration (FDA) regulate homeopathic product labels? Or does the U.S. Federal Trade Commission (FTC)? Is it both? While most members of the homeopathic industry have long understood that the FDA is responsible for over-the-counter (OTC) drug labels and labeling and the FTC is responsible for OTC drug advertising, theRead More >

A Trump Administration and a Republican-Controlled Congress

An Assessment and Outlook of the Political and Regulatory Climate for 2017 By Pete Evich, AAHP Government Relations The election of Donald Trump and a Republican-controlled Congress will mark a change from the “divided government” norm that has reigned over Washington during the last six years. While the new political environment will be more favorableRead More >

AAHP Encourages Clear and Open Communication on Teething Medicines Tragedies

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 surprisedRead More >

U.S. Senator Bob Casey to Attend Event Sponsored by Keystone State-Based AAHP Members

Executives from AAHP member companies that reside in Pennsylvania will be hosting a political event on Tuesday, Oct. 25 for one of their home state senators, Sen. Bob Casey (D). The event, which will be held at the Hyland’s Foundation Library in King of Prussia, Pa. from noon to 1:30 p.m., will be a tremendousRead More >

FTC Holds Workshop on Consumer Disclaimers

The complexity of developing and delivering product disclosures to consumers was the subject of a day-long workshop hosted by the Federal Trade Commission (FTC) on Sept. 15 in Washington, DC. While the advent of new technology like cell phones and tablets has created new technical challenges, the FTC has been interested in disclosures for mostRead More >

US FDA Establishment Inspections: Outcomes for Labelers for Homeopathic Drugs

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Understanding OTC Monograph Reform: Where Do We Stand Now?

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 OTCRead More >

Educational Webinar Resources Available

Missed FDA’s comments? You have a second chance! FDA’S VIEW ON COMPLIANCE — IN THEIR OWN WORDS May’s webinar was a big success! The event gave industry members a chance to hear directly from Mr. Brad Pace, the Acting Director of the Division of Nonprescription Drugs and Health Fraud within FDA’s Center for Drug EvaluationRead More >

FDA Guidance for Industry – Request for Quality Metrics

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 actionsRead More >

Consideration of Homeopathic Medicine as a Vaccine Alternative

 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 HomeopathicRead More >

Experts Discuss Advertising of Homeopathic Medicines at FTC Workshop

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 shareRead More >

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

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.Read More >

The Homeopathic Industry Needs YOUR Support

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 monthsRead More >

AAHP Addresses OTC Homeopathic Drug Products for Asthma

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, whichRead More >

FDA’s Quality Metrics Initiative – From Compliance to Performance

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 FDARead More >

Stability Testing

The AAHP office just received a copy of an article, Stability Testing of Medicinal Products According to Homeopathic Principles; this appeared in Pharmaceutical Industry (71, Nr. 12). The article was co-written by 8 colleagues of European companies, of which 5 are members, or related to members, of the AAHP. The article addresses the implementation, inRead More >

Deployment of FDA Inspection Resources

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2014 Elections and Effect on Homeopathic Industry

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Social Media and Products Subject to FDA Regulation

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AAHP Submits Comments to US Congress on Safety Standards for Homeopathic Drug Products

The following is the text if a letter submitted to Senators Harkin and Enzi of the Senate Health Education, labor and Pensions Committee. Read More >

Senator Harkin Writes to FDA regarding Homeopathic Drug Products

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FDA responds to Senator Harkin regarding Homeopathic Drug Products

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Overview of Homeopathic Drug Product Regulation

The Homeopathic Pharmacopoeia Convention of the United States (HPCUS) is responsible for the publication of the Homoeopathic Pharmacopoeia of the United States* (HPUS*). Through its ongoing work, the HPCUS offers assurances that homeopathic medications are safe, accessible and legal in the United States.Read More >

The AAHP Lobbies Congress on the Drug Quality And Safety Act

The issue of pharmaceutical compounding came to the fore in 2012 when it was reported that more than 50 deaths and widespread serious medical problems were the result of fungal meningitis linked to contaminated products from the New England Compounding Center (NECC).Read More >

Sen. Tom Harkin Honored for Safeguarding Americans’ Right to Choose Complementary Health Care

Senator Tom Harkin (D-Iowa) was honored recently by the American Association of Homeopathic Pharmacists (AAHP) with an award of appreciation for introducing and supporting legislation that safeguards Americans’ right to choose complementary health care. Read More >

Quality Guidance for Homeopathic Manufacturers

The American Association of Homeopathic Pharmacists (AAHP) is reminding manufacturers of homeopathic drugs to take additional steps to ensure the safety of their products. Read More >

AAHP Successfully Works with FDA to Resolve Drug Listing Issue

The AAHP established a homeopathic Drug Listing SPL Sub-Team to work with FDA’s Electronic Drug Listing group to address some of the unique challenges faced by homeopathic drug companies in complying with the requirements for electronic registrations.Read More >

Regulation of Homeopathic Drug Products

The regulation of homeopathic drug products is discussed.Read More >