Compliance
2018 Enforcement Report for Labelers of Homeopathic Drug Products
Mark Land, AAHP President The most recent year (2018) has been a busy regulatory enforcement period for manufacturers and marketers of homeopathic drug products. Review of the Food and Drug Administration’s (FDA) website reveals enforcement actions against homeopathic products at multiple levels including inspections, warning letters, and recalls. The data readm more…
Read MoreOutlook 2019: A Letter from the Board
By AAHP Board of Directors 2019 presents a unique crossroad to the homeopathic industry. As consumer demand for our products rises across North America, so does industry growth—and it is poised to continue growing. With this increased visibility comes increased scrutiny from regulatory bodies and potentially unfriendly consumer groups. While readm more…
Read MoreAccelerating into the New Year
By Mark Land, AAHP President As the homeopathic industry continues to grow, AAHP recognizes the need for constant improvement. This year, building on the momentum we gained in 2018, we plan to accelerate our efforts in the areas of advocacy, education, and outreach. All of our efforts aim to readm more…
Read MoreHow to Use Ignatia amara
(Image: Steven Edward/Flickr) By Todd A. Hoover, MD, DHt The homeopathic medicine Ignatia amara is derived from the St. Ignatius Bean (from the Strychnos ignatii plant). The tree is in the Loganiaceae family, and considered native to the Philippines and was naturalized into parts of China. The plant was first readm more…
Read MoreThe French Pharmacopeia
By Eric Foxman, R.Ph., AAHP Secretary A quick look at its structure and contents as well as two key considerations for potential adulteration and misbranding in the U.S. market. Structure The French Pharmacopeia (FP) is a publication of the National Agency for the Safety of Medicines and Health Products (ANSM), readm more…
Read MoreHow to Use Gelsemium sempervirens
By Todd A. Hoover, MD, DHt Gelsemium sempervirens is a plant substance, commonly known as yellow jasmine, native to tropical and subtropical Americas. The traditional herbal use was for a number of neurological and dermatological problems including measles, ear pain, dysmenorrhea, headaches, muscle pain, and anxiety. All parts of the readm more…
Read MoreProcess Validation of Homeopathic Medicines
By Pejman Parhami, Senior Director, Quality Systems, Hyland’s, Inc. FDA issued many warning letters regarding process validation in 2017 and 2018. were more prominent. Of the warning letters analyzed, about 40% included observations related to process validation. Since 2017, about 30 facilities were found to be noncompliant with respect readm more…
Read MoreA Brief Regulatory History of Process Validation
By Mark Land, AAHP President Finished product testing is probabilistic and not dispositive of process control; that is why we need process validation. While preparing this article I came across several histories of process validation. One that caught my attention was a book chapter written by Bernard Loftus, formerly readm more…
Read MoreThe Case for Process Validation
By Mark Land, AAHP President The Homeopathic Pharmacopoeia of the United States says: “Dosage Forms – These, like all other conditions of homeopathic production should be governed by simplicity and usefulness to the physician and patient.”1 This is a good place to start a discussion about process validation for readm more…
Read MoreReview Notice: Comparison of Machines to Potentize Homeopathic Drug Products
By Eric Foxman, AAHP Secretary In April, AAHP posted an article about the different machines used to potentize homepathic medicines. Coincidentally, Homeopathy recently published a paper comparing machines that potentize homeopathic drug products. AAHP will not reprint this paper, A Review of Machines and Devices to Potentize Homeopathic Medicines, due readm more…
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