Do veterinary drugs require Safety Data Sheets?

Veterinary practices frequently assume that drugs bearing FDA labeling fall outside OSHA's Hazard Communication Standard entirely. OSHA addressed that assumption directly in 1993 and rejected it. The FDA exemption is confined to labeling. The obligation to obtain and maintain data sheets survives it.

Background

On December 10, 1993, C.M. Stowe, VMD, PhD, of Wendt Professional Laboratories wrote to OSHA concerning the application of the Hazard Communication Standard, 29 CFR 1910.1200, to veterinary drugs. Roger A. Clark, Director of OSHA's Directorate of Compliance Programs, responded on December 22, 1993.

The threshold question is hazard, not drug status

OSHA began by locating the boundary:

The standard does not apply to nonhazardous drugs, but any drug that meets the criteria of a hazardous chemical in the HCS generally would be covered.

Drug status is therefore not the determining factor. Whether the substance meets the standard's hazard criteria is.

The FDA exemption covers labeling only

The central point of the letter, and the one most often misread:

Section (b)(5)(ii) of the HCS states that drugs that are subject to labeling requirements by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act are exempt from the labeling provisions of OSHA's Hazard Communication Standard. Please note that this section of the HCS exempts only labeling requirements and does not exempt the other requirements of the standard such as providing Material Safety Data Sheets (MSDS).

OSHA's emphasis is unambiguous. An FDA-labeled drug is relieved of the OSHA labeling obligation and of nothing else. Data sheet, training, and written program obligations are unaffected.

The solid final form exemption and its limit

A second exemption operates on physical form rather than regulatory status:

Another section of the standard that is relevant to your situation is 1910.1200(b)(6)(viii) which exempts from coverage under the standard drugs as defined by the Federal Food, Drug and Cosmetic Act that are in solid final form, ready for direct administration to the patient such as tablets, capsules or pills. If these drugs are not in final form in that they are designed to be dissolved or crushed by employees prior to administration, then they are covered by the HCS.

OSHA qualified this with a distinction that matters in practice. The exemption turns on how a product is ordinarily dispensed, not on an isolated departure: "There may be situations where a tablet, capsule or pill is dissolved or crushed for purposes of administration when that is not generally the way it is dispensed. The final form exemption would apply in this situation."

The agency then stated the resulting rule for suppliers:

Consequently, MSDS are required to be prepared and transmitted with the initial shipment of all hazardous chemicals including drug and veterinary products, except for products which are in solid final form for direct administration to patient.

State plans may differ

OSHA closed by noting that the correspondent's state operated its own approved plan, and that states "are required to adopt and enforce standards that are either identical to, or at least as effective as, the Federal standards." The agency cautioned that its response "may differ from that which would be given by the State of Minnesota." The same caution applies to any practice operating in a state plan state.

A note on terminology

This letter predates OSHA's 2012 alignment of the Hazard Communication Standard with the Globally Harmonized System. It therefore refers throughout to Material Safety Data Sheets. The current term is Safety Data Sheet, and the format is now standardized to sixteen sections. The quoted language is reproduced as OSHA wrote it. The substantive point about the scope of the FDA exemption is unaffected by the change in nomenclature.

What this means for your practice

1. Do not treat FDA labeling as a general exemption. It removes the labeling duty and nothing further. A practice that discards data sheets for FDA-labeled products on this basis is misreading the exemption OSHA describes here.
2. Apply the form test as OSHA frames it. Tablets and capsules dispensed intact for direct administration are exempt. Products routinely crushed, dissolved, reconstituted, or compounded before administration are not.
3. The ordinary course governs. An occasional departure from normal dispensing does not defeat the exemption, per OSHA's own qualification.
4. Suppliers owe you the data sheet on first shipment. If a hazardous product arrives without one, the obligation to transmit it rests with the manufacturer or importer, and it is appropriate to request it.
5. Verify your state's position if it runs its own plan. OSHA expressly declined to speak for state plan states, which may impose requirements at least as stringent as the federal standard.

This interpretation dates from 1993 and predates the 2012 GHS revision of the standard. Interpretation letters explain existing requirements and do not create new obligations, and OSHA revises its guidance as new information becomes available. Consult the original, and the current text of 1910.1200, before relying on it.