Compliance

Compliance

For more information, standards and guidelines on the manufacture of homeopathic medicines, the only legally recognized resource in the USA is the Homeopathic Pharmacopeia of the United States. This is available on-line at www.hpus.com.

The Food and Drug Administration has published it’s Compliance Policy Guide 400. 400 Conditions Under Which Homeopathic Drugs May Be Marketed. This can be downloaded here.

2017 Updates in the Homeopathic Pharmacopeia

By Eric L. Foxman, R.Ph., senior scientist, HPCUS June 1, 2017 Before proceeding to review the major areas of updates in the HPUS, two specific items are of timely interest: The Guidelines for Manufacturing Homeopathic Medicines became official on March 31, 2017. The older General Pharmacy section and the Classes of Manufacture are no longerRead 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 >

AAHP Compliance Thru Education Webinar on FDA Inspections

The association just completed another successful Compliance Thru Education webinar: FDA Inspections of Homeopathic and Drug Manufacturing Facilities: An Agency View. This webinar, held on Dec. 1, was the last of four AAHP educational events hosted during 2016. The webinar was presented by Ms. Tamera Ely, senior policy advisor from the FDA’s Office of Compliance/OfficeRead 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 >

Analytical Methods

By Mark Land, AAHP President April 1, 2017 When Samuel Hahnemann founded homeopathy at the end of the 18th century, he couldn’t possibly have fathomed the extreme capabilities of today’s analytical technologies. Most instruments currently used to assess homeopathic dilutions can resolve to below one microgram—that is to say, to less than one part perRead More >

Assays of homeopathic preparations

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Changes are Coming to Product Labels

By Alvin J. Lorman, AAHP counsel August 1, 2017 Changes are coming to your products’ labels. Not only are there changes to the Homeopathic Pharmacopeia of the United States (HPUS) on the horizon, but our association’s Board of Directors is expected to make its soon-to-be-adopted new advertising disclaimer mandatory on labels as well. And there’sRead 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 >

Consumer Advertising Guideline For Over-The-Counter Homeopathic Medicines

Homeopathic medicines play an increasing role in self-medication among American consumers. Read More >

Consumer Label Comprehension

By Mary Borneman, Sr. Director of Communications & Public Affairs, Hyland’s, Inc. March 1, 2017 It’s not news that the Internet and access to information has created what one could argue is the most knowledgeable consumer any business has ever had. From using crowdsourcing and reviews to determine the best electronic or household appliance toRead More >

Deployment of FDA Inspection Resources

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Disclaimers in Advertising and Labeling: What Do They Do? Who Does What?

By Mark Land, AAHP President May 1, 2017 The FTC has long recognized that marketing claims may include additional explanatory information to prevent the claims from being misleading. This is FTC’s way of saying disclaimers may cure potentially misleading claims in general or, in our case, homeopathic therapeutic claims specifically. Communicating information to consumers inRead More >

Disclosing Relationships with Influencers on Social Media

By Deborah Kelly, public relations manager, Boiron USA March 1, 2017 The core mission of the Federal Trade Commission (FTC) is to regulate advertising so businesses won’t mislead consumers or engage in deceptive practices that would affect behavior or decisions about a particular product or service. One area of particular concern and scrutiny is endorsements.Read More >

Document Management Systems

It is often said that the pharmaceutical industry produces two products: healthcare products and the paper that goes along with it. During the past 20 years, we have seen a transition from paper-based format to the production of electronic-based information that provides a rich foundation of presentation options. The pharmaceutical industry was reluctant to adoptRead More >

Educational Webinar Resources Available

FDA’S VIEW ON COMPLIANCE — IN THEIR OWN WORDS This webinar gives 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 Evaluation and Research (CDER), Office of Compliance. The one-hour webinar provided a very beneficial insightRead 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 >

FDA & Proprietary Names

FDA has published a draft document on “Best Practices in Developing Proprietary Names for Drugs”. This document is intended to help companies develop product names that do not cause or contribute to medication errorsor otherwise contribute to the misbranding of the drug. With safety in mind, it describes design practices to help avoid such errorsRead More >

FDA Establishes Unique Facility Identifier

In November, the Food and Drug Administration published a Guidance for Industry entitled: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration. This guidance is a direct result of the Food and Drug Administration Safety and Innovation Act of July 2012.  Sections 701 and 702 of FDASIA require FDA to specify theRead More >

FDA Office of Surveillance and Epidemiology

By Mark Land, AAHP President April 1, 2017 FDA’s Office of Surveillance and Epidemiology (OSE) is positioned within the Center for Drug Evaluation and Research (CDER). OSE evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of drugs. OSE maintains a system ofRead 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 >

Homeopathic Drug Labels: Rx or OTC?

By J.P. Borneman, Ph.D. and Alvin J. Lorman Homeopathic drugs, we proudly tell folks, really are drugs: the Federal Food, Drug, and Cosmetic Act has recognized them as such since its passage in 1938. Being characterized as a drug has many implications: our products are subject to current Good Manufacturing Practices, they must be producedRead 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 >

Homeopathic Quality by Design

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How is Homeopathic Belladonna Made?

By Mark Land, AAHP president September 1, 2017 Belladonna, more commonly known as deadly nightshade, Atropa belladonna, devil’s cherries, devil’s herb, divale, dwale, dwayberry, great morel, naughty man’s cherries, and poison black cherry, is a perennial herb that has been valued for its medicinal properties for more than five centuries. Belladonna is a member of theRead More >

Label Comprehension Studies for Nonprescription Drug Products

The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. A label comprehension study assesses the extent to which consumers understand the information on nonprescription drug product labeling and then apply this information when making drug product use decisions in aRead More >

New Drug Listing Requirement and Timetable Effective this Month

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OTC Monograph Reform

By Mark Land, AAHP president August 1, 2017 Self-medication is an important way in which American consumers treat many types of illnesses. Over-the-counter (OTC) drugs often provide effective relief in a cost-effective and accessible manner and represent the first choice of treatment for many ailments. More than 80 therapeutic categories of OTC drugs exist andRead More >

Social Media and Products Subject to FDA Regulation

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Speakers at FDA Hearing Praise Success of Homeopathic Regulatory Framework

Silver Spring, Md., April 20, 2015—The American Association of Homeopathic Pharmacists (AAHP) today told the U.S. Food and Drug Administration that the agency’s regulatory policy for homeopathic medicines has worked effectively for the last 25 years to protect the public health and provide consumer access to safe homeopathic medicines. AAHP, the industry’s trade association, wasRead 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 >

Status of English vs. Latin Names of Homeopathic Ingredients

The following is the text of letter from FDA to the HPCUS regarding the use of Latin names on Homeopathic drug products.Read More >

The European Pharmacopeia and How U.S. Manufacturers Can Use It

By Mark S. Phillips, Pharm. D. Jan. 26, 2017 On Jan. 1, 2017, the 9th edition of the European Pharmacopoeia (Ph. Eur.) became legally binding in its 37 European member countries and the European Union. Compared to the 8th edition, more than 50 percent of the text is new or revised. The European Pharmacopoeia isRead More >

The FTC and the Web

By Alvin J. Lorman, Association Counsel March 1, 2017 The recent claim by the Federal Trade Commission (FTC) that its policy statement on marketing of homeopathic drugs applies to labels and labeling as well as advertising has caused many to ask about the legal boundaries of the FTC’s jurisdiction. When you think of the FTC,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 >

The Homeopathic Pharmacopoeia of the United States

By Mark Land, AAHP president June 1, 2017 The Homeopathic Pharmacopoeia of the United States (HPUS) is the legal basis for marketing homeopathic drug products in the United States and many other countries around the world. The HPUS is officially recognized in the United States Federal Food Drug and Cosmetic Act and other United StatesRead More >

The Importance of Standard Operating Procedures

By Mark Land, AAHP President Manufacturers of health care products rely on precision, rigor and consistency to produce reliable products for patients, physicians and consumers time and again. To drive the kind of culture that consistently and effectively produces results of this nature, companies must first create a culture where quality objectives are transparent, wellRead More >

The Road to OTC Monograph Reform

By Barbara A. Kochanowski, senior vice president of regulatory and scientific affairs Consumer Healthcare Products Association August 1, 2017 For the past three years, the regulated industry has been working with the U.S. Food and Drug Administration (FDA) to reform the OTC Monograph System, the regulatory framework under which most over-the-counter (OTC) products are regulated.Read More >

The State of Technology in Homeopathic Medicine

By Jim Duquesnel, VP-R&D, Hyland’s, Inc. April 1, 2017 “Be careful what you ask for!” This phrase surfaces more often than I would like in the pursuit of advancing homeopathic technology. In six-sigma training years ago, I had admired W. Edwards Deming’s emphasis on quality as the reduction in variability and control of consistency. ThoseRead More >

The Tale of the Contract Manufacturer: A Story Based on an AAHP Member Question

By Eric Foxman, AAHP Secretary Once upon a time, a special creature, the CIAMP (Company Interested in Alternative Medical Products), wanted Phoxman Farmaceuticals (PhoxFarm) to contract manufacture a product for it. Over cheesecake and ice cream, they discussed the project and agreed to do business together. The CIAMP created the formula, designed the labeling andRead More >

Two Informative FDA Guidance documents

FDA has issued a Guidance for Industry document, ANDA Submissions ― Refuse-to-Receive Standards, which contains helpful hints on the Agency’s thinking and practices. Much of the contents may not be applicable to members of our industry, because homeopathic drug products are, by and large, not subject to the ANDA process, but hidden within the GuidanceRead More >

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 >

Unseen Plant Contaminants In Raw Materials

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US FDA Establishment Inspections: Outcomes for Labelers for Homeopathic Drugs

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Webinar Review: FDA’s View on Compliance

On May 24, 2016, the American Association of Homeopathic Pharmacists hosted the latest in its Compliance through Education webinar series. The webinar featured a presentation from Brad Pace, acting director of the Food & Drug Administration Compliance Office’s Division of Nonprescription Drugs and Health Fraud, on best manufacturing and labeling practices for homeopathic drug products.Read 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 >

What homeopathic manufacturers need to know, and what the FDA wants to see.

By Eric Foxman, AAHP Secretary Late last month, I joined Mark Vermette and Lyn Agostinelli of Halloran Consulting Group as they prepared for our upcoming Compliance Thru Education webinar: Document Control. I heard their presentation points and had a glimpse at their presentation materials. Simply put, they are packing a lot of information into aRead More >

What is the HPUS and Who Creates It?

By Eric L. Foxman, R.Ph., senior scientist, HPCUS June 1, 2017 Various pharmacopoeias containing homeopathic drugs have been published continually since the 1840s. The Homeopathic Pharmacopoeia of the United States (HPUS) has been in continuous publication for 120 years — since 1897. The HPUS was officially recognized under the U.S. Food Drug and Cosmetic ActRead More >

What’s a Hippus?

Like other over-the-counter drug communities, the homeopathic industry spends thousands of hours each year researching and reviewing the effectiveness and safety of ingredients to be used in homeopathic remedies. All of this work goes into the Homeopathic Pharmacopoeia of the United States (HPUS), the reference book for the Identification, Quality Standards, and Production Methods forRead More >