Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

OSHA MATERIAL SAFETY DATA SHEETS WOULD COST DRUG WHOLESALERS

Executive Summary

OSHA MATERIAL SAFETY DATA SHEETS WOULD COST DRUG WHOLESALERS more than $ 10 mil. per distribution center, the National Wholesale Druggists Association (NWDA) projected in Sept. 28 testimony before the House Small Business Subcommittee on Exports, Tourism and Special Problems, chaired by Rep. Sisisky (D-Va.). "NWDA estimates each distribution center having to make 4,8 mil. copies of 12.000 MSDSs (material safety data sheets), which, conservatively assuming an average page length per MSDS of four, would mean each distribution center distributing 19.2 mil. pages to pharmacies," NWDA said. "The average wholesaler is expected to incur costs in excess of $ 10 mil. per distribution center to comply with this requirement." The congressional testimony reiterates earlier comments to the Occupational Safety & Health Administration (OSHA) following an Aug. 19 Third Circuit Court ruling that overturned the Office of Management& Budget's decision to disapprove portions of the proposed reg ("The Pink Sheet" Sept. 5, T&G-8). The association has maintained that employees of distributors, pharmacies and hospitals already have access to FDA- approved labeling, particularly through the Physician's Desk Reference, and that access to the labeling by workers in the drug distribution system meets OSHA's proposed regulation requiring distribution of MSDSs. "Our customers . . . often are served by more than one drug wholesaler, [and] that means that the flood of paperwork coming to them from us will also come to them from two or three others," NWDA continued. "All of this cost and effort would be to provide generic, misleading and incomplete information is the form of MSDSs to professionals who already have published volumes of FDA-required, exact and detailed information on their shelves."

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS014452

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