Cytotoxic drug mixing in a pharmacy and the laboratory standard

June 22, 1990

Mr. Gerard L. Baril
Senior Industrial Hygienist
Lovell Safety Management Company, Inc.
[Recipient address omitted]
Dear Mr. Baril:

This is in further response to your letter of April 30, requesting clarification of the Occupational Safety and Health Administration (OSHA) standard 29 CFR 1910.1450, Occupational Exposures to Hazardous Chemicals in Laboratories. You wanted to know if a pharmacy operation where cytotoxic drugs are mixed would fall under the requirement of the laboratory standard.

According to the laboratory standard, the word "laboratory" means a facility where "the laboratory use of hazardous chemicals occurs." As outlined in 29 CFR 1910.1450(a) (1), the determination of whether the laboratory standard applies is dependent on both "laboratory use" and "laboratory scale" criteria.

A pharmacy operation mixing cytotoxic drugs does not meet the "laboratory use" criteria because the operation simulates a production process. Laboratories generally have many hazardous chemicals present to which exposures are intermittent rather than a few substances to which there are regular exposures, as in the type of pharmacy you described. Because this pharmacy operation is not within the scope of coverage under the laboratory standard, your second question regarding the chemical hygiene plan would not be relevant.

OSHA has published guidelines on the handling of cytotoxic drugs entitled "Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs." This OSHA Instruction PUB 8-1.l has been available to the public since January 29, 1986. Enclosed is a copy for your reference.

If we can be of further assistance, please do not hesitate to contact us again.

Sincerely,
Gerard F. Scannell
Assistant Secretary

Enclosure

[Requester letter reproduced on OSHA page; omitted here.]