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.

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 >

Assays of homeopathic preparations

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here. Existing Users Log InUsernamePassword Remember Me  

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 >

Deployment of FDA Inspection Resources

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here. Existing Users Log InUsernamePassword Remember Me  

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

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 >

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’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

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here. Existing Users Log InUsernamePassword Remember Me  

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 >

Social Media and Products Subject to FDA Regulation

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here. Existing Users Log InUsernamePassword Remember Me  

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 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 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 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

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here. Existing Users Log InUsernamePassword Remember Me  

US FDA Establishment Inspections: Outcomes for Labelers for Homeopathic Drugs

This content is restricted to AAHP members. If you are a member, please login. If you are not a member, click here. Existing Users Log InUsernamePassword Remember Me  

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’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 >