Compliance

Label Comprehension Studies for Nonprescription Drug Products

December 14, 2016

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 a…

The Importance of Standard Operating Procedures

November 9, 2016

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, well…

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…

Document Management Systems

September 2, 2016

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 adopt…

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

September 1, 2016

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 a…

US FDA Establishment Inspections: Outcomes for Labelers for Homeopathic Drugs

June 28, 2016

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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…

Webinar Review: FDA’s View on Compliance

June 7, 2016

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.…

Homeopathic Drug Lables

Homeopathic Drug Labels: Rx or OTC?

June 1, 2016

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 produced…

wt hippus

What’s a Hippus?

March 31, 2016

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 for…

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