Deployment of FDA Inspection Resources

By Mark Land, VP Operations and Regulatory Affairs at Boiron A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Food Drug and Cosmetic Act (1938). FDAContinue Reading

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 theContinue Reading

Publications Review – A Treasure Source

AAHP Board member Mary Beth Watkins notes two periodicals containing articles that may be of interest to industry members. In the American Journal of Homeopathic Medicine (Vol. 107, No 3, Autumn 2014), we find the wonderful news regarding an award given to long time AAHP Member, John A (Jack) Borneman, III. In addition, H1N1 Influenza: AContinue Reading

Retirement for…

We have received word that AAHP member Richard Griffin, of Grifcon Enterprises, has decided to retire as of the end of this year. As he mentioned in his note: Fifty years is long enough to be in the insurance business. Dick has been instrumental in making donations over the last 4 years to help underwriteContinue Reading

Change, Growth, and Successes

The past 12 months have been one of change, growth and successes for the American Association of Homeopathic Pharmacists. These continued the positive achievements of the association during the 90th anniversary year of 2013. January 2014 saw the introduction of  a new logo for the AAHP that was the result of a collaborative effort onContinue Reading

Assays of homeopathic preparations

An interesting contribution, Quality Aspects Of Homoeopathic Preparations, appeared in Pharmeuropa Online, a publication of the European Directorate for the Quality of Medicines and HealthCare (EDQM). In his paper, Professor Keusgen notes chemically defined substances usually have a dose-response curve that defines efficacy, and thus assays are required for both quality and safety reasons.  However,Continue Reading

2014 Elections and Effect on Homeopathic Industry

This Month’s Election and the Homeopathic Industry by Pete Evich of van Scoyoc Associates This overview provides a succinct discussion of how the November 4th U.S. Congressional elections may affect committees that matter most to the homeopathic drug industry Even the most casual observers of American politics are aware that Republican candidates fared extremely wellContinue Reading

Recall Trends 2Qtr 2014

Each quarter, Stericycle produces a summary report of recalls affecting several industries, including the overall Pharma category. With snapshot graphics, the report notes that Pharma recalls are inching steadily upwards. However, the accompanying text provides some insights into the background of why this may be happening. For instance, “a mislabeling issue could arise from workingContinue Reading

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 GuidanceContinue Reading

Sept ’14 Member Meeting Successes

The AAHP’s Semi-Annual Member Meeting in Baltimore was an unparalleled success with two new highlights capping the event. After an opening welcome by AAHP President Mark Land, the meeting began with an informative roundtable discussion by Al Lorman, Pete Evich and Jay Borneman. Each provided a quick perspective on current challenges facing the industry. AmongContinue Reading