Controlled substance and OSHA compliance in veterinary practice

Scope and limits of the cited rules

The DEA material used here is the regulation text itself: 21 CFR Part 1304 and the Part 1301 security sections [1][2]. Those rules also govern manufacturers, distributors, pharmacies and collectors. This checklist uses only provisions that apply to practitioners and dispensers. Nothing in the cited DEA text mentions veterinary medicine.

The cited sources do not address:

• State pharmacy board, veterinary board or state radiation rules.
• Schedule II ordering procedures or disposal procedures under Part 1317, beyond the record of destruction described below.
• Any OSHA standard on ionizing radiation, personal protective equipment or waste anesthetic gases.

The OSHA standard states that no state may adopt or enforce requirements on the issue it addresses "except pursuant to a Federally-approved state plan" [3]. The cited sources do not describe any state plan requirements.

DEA recordkeeping checklist

Part 1304 sorts a practitioner's handling of controlled substances into dispensing, prescribing and administering, and the record duty differs for each [1]. The regulation explains that DEA's intent is "to permit the registrant to keep one set of records which are adapted by the registrant to account for controlled substances used in any activity" [1].

• Record Schedule II through V substances dispensed, other than those prescribed or administered in lawful professional practice (1304.03(b)) [1].
• Prescribing alone does not require a record under 1304.03(c), except as 1304.06 provides or when the prescription is for maintenance or detoxification treatment of an individual [1].
• Administered substances require records when the practitioner "regularly engages in the dispensing or administering of controlled substances and charges patients" for them, separately or bundled with other services (1304.03(d)) [1].
• For each dispensing, 1304.22(c) calls for:
• the quantity or volume;
• the recipient's name and address;
• the date;
• the written or typewritten name or initials of the individual who dispensed or administered it [1].
• Keep a current, accurate record of every substance received, sold, delivered or otherwise disposed of. Section 1304.21 says no registrant is required to maintain a perpetual inventory [1].
• Date each entry with the day the receipt, transfer or destruction took place [1].
• Keep Schedule I and II records apart from all other records. Keep Schedule III through V records either apart or readily retrievable from ordinary business records (1304.04(f) and (g)) [1].
• Keep separate records for each registered location [1].
• An in-house computer system needs no DEA notice or central recordkeeping approval (1304.04(c)) [1].
• Destruction records under 1304.21(e) [1]:
• When destroying a substance under 1317.95, record it on DEA Form 41 with the names and signatures of the two employees who witnessed it.
• Leftover drug from a dose given for immediate administration at the registered location is recorded under 1304.22(c) instead, without Form 41.
• A practitioner issuing electronic prescriptions for controlled substances uses an application that keeps the digitally signed record and its internal audit trail (1304.06) [1].

DEA inventory checklist

Section 1304.11 requires each inventory to be a complete and accurate account of everything on hand on the inventory date [1].

• Take an initial inventory on the first day of dispensing. If nothing is on hand, record that as the initial inventory [1].
• Take a biennial inventory on any date within two years of the previous one [1].
• When DEA adds a previously unscheduled substance to a schedule, inventory stocks of it on the rule's effective date [1].
• Keep the inventory in written, typewritten or printed form at the registered location. Transcribe promptly any inventory dictated to a recording device [1].
• Note on the inventory whether it was taken at opening or close of business [1].
• Count as on hand anything under the practice's possession or control. List stock held at an unregistered site on the inventory of the responsible registered location [1].
• For dispensers, 1304.11(e)(6) requires [1]:
• each finished form;
• the units or volume per commercial container;
• the number of containers;
• the quantity and reason for holding items such as damaged stock awaiting disposal.
• For opened containers [1]:
• Schedule I or II requires "an exact count or measure of the contents."
• Schedule III through V may be estimated "unless the container holds more than 1,000 tablets or capsules."
• Keep inventories at each registered location, even where other records are kept centrally (1304.04(b)(1)) [1].

DEA storage, staffing and loss reporting checklist

Section 1301.71 requires every registrant to provide "effective controls and procedures to guard against theft and diversion of controlled substances" [2]. DEA may accept substantial compliance after weighing factors that include the quantity handled, the location, key and combination control, alarm systems and supervision of employees [2]. The same section says security must expand when holdings rise significantly in normal business [2].

• Store Schedule I substances, and Schedule II through V substances, in a securely locked, substantially constructed cabinet. The option to disperse stock among noncontrolled drugs is limited to pharmacies and institutional practitioners (1301.75) [2].
• Store thiafentanil, carfentanil, etorphine hydrochloride and diprenorphine in a safe or steel cabinet "equivalent to a U.S. Government Class V security container" [2].
• Do not employ, as an agent or employee with access to controlled substances, anyone who has [2]:
• been convicted of a felony offense relating to controlled substances;
• had a DEA application denied;
• had a DEA registration revoked;
• surrendered a DEA registration for cause (1301.76(a)).

The rule defines "for cause" as a surrender in lieu of, or as a consequence of, action stemming from an investigation of the person's controlled substance handling [2].

• On discovering a theft or significant loss, send written notice to the area DEA Field Division Office within one business day. Then file a complete DEA Form 106 through the Diversion Control Division secure network application within 45 days (1301.76(b)) [2]. The cited text of 1301.76(b) introduces factors for judging whether a loss is significant but does not list them [2].
• If the practice distributes controlled substances without a distributor registration, 1301.76(c) applies three non-practitioner duties [2]:
• a good-faith check that the recipient is registered;
• a system to flag suspicious orders;
• choosing carriers with adequate security.

OSHA hazard communication checklist

The standard requires all employers to inform employees about hazardous chemicals they are exposed to. It says employers that neither produce nor import chemicals need only focus on the workplace program and employee communication parts [3]. It covers any chemical present in a way that could expose employees "under normal conditions of use or in a foreseeable emergency" [3].

Two drug provisions apply [3]:

• Drugs in "solid, final form for direct administration to the patient (e.g. tablets or pills)" are excluded from the standard.
• Drugs a pharmacy dispenses to a health care provider for direct administration are exempt from labeling.

The checklist:

• Maintain a written hazard communication program at each workplace describing how labeling, SDS and training requirements are met [3].
• Include a list of hazardous chemicals present, using product identifiers that match the SDSs. Also include the methods for informing staff about hazards of non-routine tasks [3].
• Where contractors' employees could be exposed, add how they get SDS access, precautions and the labeling system [3].
• Make the program available on request to employees, their designated representatives, the OSHA Assistant Secretary and the NIOSH Director [3].
• Keep an SDS for each hazardous chemical used, readily accessible to employees during every shift. Electronic access is allowed if it creates no barrier to immediate access [3].
• Label workplace containers in legible English with either [3]:
• the full shipped-container label information; or
• the product identifier plus general hazard information.
• Do not remove or deface incoming labels. Portable containers for the immediate use of the employee who filled them are exempt [3].
• Train employees at initial assignment and whenever a new chemical hazard enters their work area. Training covers detection methods, the hazards, protective measures, and how to read labels and SDSs [3].
• For employees who travel between workplaces during a workshift, the program and SDSs may stay at the primary facility, provided employees can get the information immediately in an emergency [3].
• Under the 2024 revision, employers update alternative labeling, the program and training for newly identified hazards by these dates [3]:
• November 20, 2026 for substances;
• May 19, 2028 for mixtures.

Other workplace hazards named by NIOSH

NIOSH describes the hazards veterinary and animal care workers face, and its page is guidance rather than regulation [4]. It lists:

• Bites, scratches, kicks, crush injuries and lifting strains from animal contact [4].
• Chemical exposure through the skin or inhalation, including splashes to eyes and mucous membranes [4].
• Ionizing radiation, which NIOSH calls "a known reproductive hazard," from x-ray machines, fluoroscopy and patients treated with iodine-131 [4].
• Zoonoses. NIOSH states that about 60% of more than 1,400 human pathogens are zoonotic [4].
• Needlestick injuries, animal allergens, noise, outdoor exposures, driving fatigue and work stress. NIOSH notes an increased suicide rate among veterinary professionals [4].