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Rx DRUG PACKAGE INSERTS SHOULD SATISFY OSHA REQUIREMENTS

Executive Summary

Rx DRUG PACKAGE INSERTS SHOULD SATISFY OSHA REQUIREMENTS for material safety data sheets (MSDS's), the National Wholesale Druggists Association (NWDA) contended in Aug. 25 comments to the Occupational Safety & Health Administration (OSHA). The association cited comments submitted one year earlier on the agency's proposal to require distribution of MSDS's to employees who handle potentially hazardous chemicals, including certain drugs not in solid form. In its 1987 letter, NWDA noted that employees of distributors, pharmacies and hospitals already have access to FDA-approved labeling, particularly through "commonly available texts, such as the Physician's Desk Reference." The association maintained that the access to FDA-approved labeling by workers in the drug distribution system meets OSHA's regulation requiring distribution of MSDS's. NWDA reiterated its position on the reg after an Aug. 19 Third Circuit Court ruling overturned a decision by the Office of Management & Budget to disapprove portions of the reg. OMB's decision would have nixed those sections of the reg pertaining to information collection requirements for the coverage of any drugs regulated by FDA. The federal appellate court, in a complaint filed by the United Steelworkers and the AFL-CIO-CLC against OSHA et al, ordered the agency to publish "forthwith" in the Federal Register a notice that portions of the regulations "which were disapproved by OMB are now effective." In effect, the ruling orders OSHA to require pharmaceutical manufacturers and wholesalers to distribute MSDS's. In its opinion, the court wrote that "nothing in the Paperwork Reduction Act of 1981 suggests a congressional intention to allow OMB, in the guise of regulating collection information, the authority to second guess other federal agencies with respect to the kinds of disclosure needed to accomplish substantive policies entrusted to such agencies."

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