Phase 1 Advisory Panel Review

The panels were asked to categorize the active ingredients in each class of products and their claims into one of three categories based on review of data submitted by manufacturers, scientific data in the literature, and their own experiences. The three categories (24, 25) are as follows:

Category I: generally recognized to be safe and effective for the claimed indications

• Category II: not generally recognized as safe and effective or unacceptable for the claimed indications

Table 9.1 OTC Monographs

Already Published

Still Pending

Acne Anorectal Antacid Anthelmintic Antibiotic first aid Anticaries Antiemetic Antiflatulent Antifungal Cholecystokinetic Corn/callus removers antihistamine Coughlcold antitussive Coughlcold bronchodilator Coughlcold expectorant Coughlcold nasal decongestant Dandruff/seborrhea/psoriasis Deodorants (internal) Male genital desensitizers Nighttime sleep aids Otic (earwax) Pediculicide Stimulant Sunscreen Wart remover Weight control

Source: Ref. 28 (Reproduced with permission from Consumer Healthcare Products Association).


Antiseptic first aid Antiseptic (professional) Antiperspirants combinations External analgesic Internal analgesic Laxative Menstrual Oral discomfort Oral health care Otic (ear drying) Overindulgence Poison treatment Skin bleaching— (reproposal) Skin protectants Vaginal drug products (douches)

• Category III: insufficient data available to permit final classification into Category I or Category II

The above three-category classification system is not in use today. Drugs applied for OTC use are classified either as "monograph" or "non-monograph" status. The findings of the advisory panels were published in the Federal Registry as "advance notice of proposed rule-making" (ANPR), which sets forth the advisory panel's recommendation for OTC monograph by category of use (Table 9.1), including recommendations on general recognition of safety and effectiveness for each active ingredient. This phase of review took about 10 years to complete. Phase 2: FDA Review. After publication of an advance notice of proposed rule-making, any interested party may submit comments and additional new data to support their point of view. The FDA reviews all the comments and newly submitted data and published their rulings in a "tentative final monograph" (TFM) or proposed rule, which sets forth FDA's revisions to the ANPR relating to active ingredients and conditions of use. The TFM groups actives together for specific indications to form what we now call a "monograph" (Table 9.1). The rulings on those actives and indications where no claims can be made are called "negative monographs" (Table 9.2). In a similar manner to the ANPR, additional comments and data could be submitted to clarify or refute the rulings. Phase 3: The Final Monograph. After reviewing comments to the proposed rule (or TFM), the FDA publishes the "Final Monograph" in the form of a "Final Rule" in the Federal Register, which is then incorporated into the Code of Federal Regulations (21CFR part 330). The final monograph consists of a list of active ingredients approved for the specific indications, labeling, general provisions,

Table 9.2 Negative Monograph (Non-Monograh)


Benign prostatic hypertrophy Boil treatment C/C anticholinergic Daytime sedatives Digestive aids

Exocrine pancreatic insufficiency Fever blisterlcold sore (internal) Hair grower


Ingrown toenail Insect repellant (oral) Nail biting/thumb sucking Oral wound healing Prevention of inebriation Smoking deterrents Stomach acidifiers Vaginal contraceptives

Source: Ref. 28 (Reproduced with permission from Consumer Healthcare Products Association).

and testing procedures. During the OTC Drug Review, misbranded products that did not meet the monograph requirements would need to be reformulated, or their labels needed to be revised to stay on the market. A drug manufacturer can market an OTC product based on those active ingredients for the intended indications described in the monograph without the need of an NDA submission. However, a drug manufacturer cannot make claims not described in the monograph unless they submit additional data to petition for a revision of the final monograph or justify their deviations and obtain approval through an NDA. Even though the monographs are based on active ingredients and not on the dosage forms, the implicit assumption is that the dosage forms (e.g., tablet, capsule, liquid) will not affect the efficacy and safety of the active. Whereas acetaminophen immediate-release tablets, capsules, and liquids can be marketed without an NDA submission, marketing a sustained-release acetaminophen tablet will still require a submission of an NDA deviation.

Although most of the final monographs have been published, there are still 17 final monographs awaiting completion (Table 9.1). The OTC review process is dynamic in the sense that final monographs can be amended. New ingredients or indications can also be petitioned for monograph status based on material time and material extent (29). For example, foreign OTC products and existing OTC actives approved through an NDA can be petitioned for monograph status after a certain period of marketing.

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