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



Executive Summary

TABLET I.D. IMPRINT SYSTEM IS UNDER ACTIVE REVIEW AT FDA, Office of Drug Standards Director Peter Rheinstein, MD, told the National Association of Pharmaceutical Manufacturers annual meeting in Dorado Beach, Puerto Rico on Jan. 30. Rheinstein said that the agency will be publishing a Federal Register notice "shortly" asking for comments on a petition submitted by the NAPM urging the adoption of a coding system. "We will also be asking people to send in samples of the existing coding systems which they have," he said. One type of imprint system could incorporate an abbreviation for both the active ingredient and the product manufacturer, Rheinstein observed. For instance, a three or four-letter abbreviation of the active ingredient with the number of milligrams might appear on one side of the tablet and a similar abbreviation for the manufacturer on the other. Rheinstein said that the agency was also considering the inclusion of a batch identifier "or something that could identify roughly when it was made and when it expired" to allow for easier identification and removal of problem products. FDA would probably use a "phase-in" period for submission of an imprint system on solid oral dosage forms, Rheinstein noted. "Also there will be the usual mechanism to apply for exemptions if your dosage form is just too small to get all the required information in there." An imprint system requirement has been actively sought by the NAPM over the last few years. NAPM Counsel Milton Bass (New York City law firm Bass & Ullman) explained at the session that added impetus for a uniform identification system has come from a U.S. Defense Department requirement that government orders contain an identification code. "If you have 15 companies applying for that government order you are going to have 15 different codes for that same active ingredient," Bass said. "I believe that this will be a very persuasive factor for why we have to adopt the kind of code that NAPM is suggesting." Rheinstein added that Congress has also expressed an interest in developing a uniform coding system to help in emergency tracking of products and to improve consumer awareness of specific drugs.

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




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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