Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

P-A's INDUSTRY GUIDELINES FOR IDENTIFYING INACTIVE INGREDIENTS IN OTC MEDICINES

Executive Summary

(1) The package of an over-the-counter medicine intended for retail sale (but including samples and institutional packages) should contain an alphabetical listing of its inactive ingredients, including colors. The listing should be prefaced by language such as "also contains," "other ingredients" or "inactive ingredients" so as to distinguish clearly between active and inactive ingredients. (2) The listing should be legible and visible to consumers at point of purchase. (3) A small product container (one with a total surface area of less than 12 square inches and which is not contained in an outer container, such as a carton) may list its inactive ingredients in accompanying labeling, such as counter or shelf display. (4) Flavors and fragrances may be listed as "flavors" and "fragrances." (5) Ingredients which may be but are not always present in a product should be identified by words such as "or" or "may also contain." (6) An ingredient whose identity is a trade secret need not be disclosed if the inactive ingredient list states "and other ingredients." For purposes of the Guideline, an ingredient constitutes a trade secret if its presence confers a significant competitive advantage on its manufacturer and the identity of the ingredient cannot be determined using modern analytical technology. (7) The name of an inactive ingredient should be taken from the most current edition of the following reference works: (i) United States Pharmacopeia/Natl. Formulary. (ii) USAN and USP Dictionary of Drug Names. (iii) CTFA (Cosmetic, Toiletry and Fragrance Assn.) Cosmetic Ingredient Dictionary. (iv) Food Chemicals Codex. An ingredient not listed in any of the above reference works should be identified by the name generally recognized by consumers, or if none, the chemical or other technical name. (8) Incidental ingredients which are present in the product at insignificant levels and that have no technical or functional effect need not be identified, unless the omission of the incidental ingredient would constitute a failure to reveal a material fact. Voluntary compliance with these Guidelines should begin when the appropriate product labeling is next reprinted. In any event, all products packaged on or After Dec. 1, 1985, should be in compliance.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1134025

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel