Tentative final monographs

FDA (2005) Phenylpropanolamine-containing drug products for over-the-counter human use tentative final monographs. Federal Register, 70, 75988-75998. 

The Federal Register advance notice is a preliminary notice, offering opportunity for comment and submission of new data for consideration. When all comments have been collected and evaluated, the FDA publishes a rule, also termed a tentative final monograph. This publication incorporates all changes that were made on the basis of the results of the first publication. There is a review of comments made and a summary of the basis for decisions regarding these comments. That is, the FDA prints a review of the nature of the comments or objections that were filed in response to the first notice and is obligated to respond to these comments. This should be carefully studied, because it reflects both the scientific viewpoint of the advisory panel and the FDA policy decisions. 

The publication of the tentative final monograph also provides further opportunities for submission of more data, additional comments and objections, or requests for a hearing with the Commissioner of Food and Drugs. Again, full instructions for submitting comments are provided at the end of the Federal Register entry. 

Department of Health and Human Services. (1998) Laxative Drug Products for Over-the-Counter Human Use Proposed Amendment to the Tentative Final Monograph. Federal Register. 63, 33592-33595. 

The documentation and legal requirements for surgical scrub products are similar to those for preoperative skin preparations. In general, products must meet the efficacy requirements of clinical trials utilizing human test subjects, as well as a series of in vitro tests, including time-kill and minimum inhibition studies. The actual requirements are presented in the FDA s Tentative Final Monograph of OTC products. 

After reviewing all comments in response to the proposed order, a Tentative Final Monograph is published that establishes conditions for OTC drugs considered safe and effective and not misbranded. Interested parties are invited to comment on the TFM and information used to establish the FM. Upon publication of the FM, all products not conforming to the safety and efficacy requirements are removed from the market or evidence must be provided to prove that the product now meets the requirements for safety and efficacy specified in the monograph. This information must be submitted through the new dmg approval process, as discussed later in this chapter. 

Food and Drug Administration. Tentative final monograph for healthcare antiseptic drug products proposed rule. Fed Reg 59(116) 31402-31452, 1994. 

In the last 30 years the types and forms of antimicrobial products have evolved and now include bar soaps, liquid soaps, lotions, hand dips, hand sanitizers, foams, and rub products. In the United States the importance and need for antimicrobial products was recognized by an expert panel convened by the Food and Drug Administration (FDA) in 1972, and in two Tentative Final Monographs... 

The CTFA Final Report on the Safety Assessment of benzethonium chloride, published in 1985, concludes that this QAC is safe at levels of 0.5% in cosmetic products applied to the skin [8]. It was noted that benzethonium chloride produced mild skin irritation at 5% but not at lower concentrations. The report also limits the maximum concentration of 0.02% of this ingredient for cosmetics used in the eye area. The FDA s tentative final monograph (21CFR333) for first aid antiseptics specifies that benzethonium chloride s safe and effective concentrations are 0.1-0.2% for these products [14]. Aqueous and alcohol solutions of benzethonium chloride are not absorbed through the skin [15]. Oral LD50 values of 368-654 mg/kg in rats have been reported [16], Benzethonium chloride has also been shown to be nonmutagenic in at least two different types of tests [17,18]. 

Tentative Final Monograph for Healthcare Antiseptic Drug Products, Proposed Rule. Federal Register, Food and Dmg Administration, June 17, 1994. 

Tentative Final Monograph for Antiseptic Drug Products, Part 21 CFR, Parts 333 and 369. Food and Drug Administration, Department of Health and Human Services, Part 3. Federal Register, Vol. 59, No. 116, Friday, June 17, 1994, pp. 31402-31452. 

FDA in its OTC drug review that began in 1972 has a suggested protocol for patient preparation for surgery in its latest publication of the Tentative Final Monograph (TFM). This is a trial using subject volunteers but is not considered a clinical trial since the target evaluation is reduction in microbial flora in a confined test situation [52,53]. [Parts of the protocol will be discussed, but see... 

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