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 FDAContinue Reading

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, inContinue Reading

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