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…

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Outlook 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…

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Accelerating 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…

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How 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…

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The 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…

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How 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…

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Process 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…

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A 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…

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The 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…

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Review 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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