Radio Frequency Identification (RFID) in the Pharmaceutical Supply Chain
RFID is a technology that uses radio waves to automatically identify objects. RFID technology can deliver many benefits, from tracking work in process to speeding throughput in a warehouse.
Prudent Use of Special Warnings on Labels?
The HPCUS Council on Pharmacy (CoP) has discussed the appropriateness of warning statements for a number of homeopathic substances. The discussion only focused on low attenuations of three substances.
Customs-Trade Partnership Against Terrorism
By Joerg Zimmer and Mark Land Introduction: In direct response to 9/11, the US Customs Service, now U.S. Customs and Border Protection (CBP) challenged the trade community to partner with CBP to design a new approach to supply chain security focused on protecting the United States against acts of terrorism by improving security while simultaneously…
Assisting the Patient Who Uses Homeopathic Medicines
The strong growth in natural products has led to an increasing number of homeopathic medicine departments in pharmacies across the country. Because there is still much controversy and misunderstanding by patients surrounding homeopathic medicine, U.S.Pharmacist asked Andy Bormeth, R.Ph. of the American Association of Homeopathic Pharmacists (AAHP), which represents the homeopathic drug industry and works as a liaison with FDA, state boards of pharmacy and pharmacy organizations, to discuss how pharmacists can best assist patients who use homeopathic medicines, the role homeopathy plays in health care, and to answer some basic questions regarding homeopathy.
FDA’s Electronic Filing System for Facility and Drug Registrations
On October 23, 2008 the FDA released its draft guidance on the new electronic submission system for drugs and establishment registrations.
Homeopathic Industry Perspectives — Can More Be Better?
Natural products’ consumers now have more choices than ever in the homeopathic medicinal category.
Finished Product Testing
Current Good Manufacturing Practices (cGMPs) require manufacturers of homeopathic drug products to establish finished product specifications and to ensure product quality by testing products for conformance to specifications prior to release.
FDA Requirements for Final Product Testing: Current State of Regulation and Implications for the Industry
Final Product Testing of drug products has been a fixture in Title 21 of the Code of Federal regulations. Since the outset, this requirement has caused some difficulty for the manufacturers of homeopathic drug products (HDPs) since the final drug concentration in the final homeopathic dosage form often fell below the limits of measurement.
History and Current Status of Homeopathic Drugs and the Mass Market
It goes without saying that the status of homeopathic OTC drugs sold on the mass market has drastically changed in the past two decades. In fact, in the early 1990s there were virtually zero homeopathic products sold in drug, grocery and mass merchandise stores.
OTC & Dietary Supplement Combination Products
In 2008, the Tan Sheet reported that Bayer had received warning letters reinforcing the FDA’s ban on Supplement/Drug Combination products stating that the two Bayer HealthCare products combining aspirin with dietary supplements are unapproved new drugs.