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.
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.
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.
Do you worry about your child suffering from painful recurring earaches and diarrhea during the flu season? Did you know that homeopathy with its rich history and many kid friendly dosage forms, offers help and hope by triggering the body’s own defenses and without causing side effects?
The July 2007 issue of Homeopathy; The Journal of the Faculty of Homeopathy, is a special issue devoted entirely to the science and commentary surrounding investigations of homeopathic remedies and the theories of water memory as an explanation for homeopathic potencies.
Homeopathic medicines have been classified as drugs in the United States since their inclusion in the Federal Food, Drug, and Cosmetic Act of 1938 (FFD&CA).
On January 12, 2007 FDA published a new Rile that describes the use of materials derived from cattle in medical products intended for use in humans and drugs intended for use in ruminants.
The FDA has recently been communicating with the drug industry regarding the safety of consumers, and particularly of children, using OTC liquid cough and cold medications, emphasizing the importance of correct dosing to consumer safety.