QUAD A understands that anesthesia providers conducting central ordering and transporting controlled substances to various care locations is a common practice. In turn, there has been a great deal of uncertainty about this requirement for many years. As a result, QUAD A has devoted considerable resources to ensuring we understand the DEA requirements and have been attempting to provide clear education where possible. We hope that the information below will aid facilities in achieving and maintaining ongoing compliance with QUAD A standards and the law.
Per the Medical Director Attestation that each QUAD A-accredited facility must sign and submit annually as part of the accreditation program, the Medical Director “must ensure and attest that the facility meets all local, state, and federal regulations, since such governmental regulations may supersede QUAD A Standards. Please note, however, that the stricter regulation applies, whether it is the federal, state, or local regulation, or the QUAD A standard.”
Controlled substance regulations are primarily set by the U.S. Department of Justice, Drug Enforcement Administration (DEA). The DEA requires that your registered address must be the physical location of your principal place of business or professional practice where controlled substances are manufactured, distributed, imported, exported, or dispensed.
Additionally, a separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person. Controlled substance delivery to a private residence or PO Box is not allowed by this regulation. The intent of this registration is to implement a closed system of distribution. A practitioner can only administer, dispense, procure, or store a controlled substance at a location where he or she is registered with the DEA.
The one exception to the above is the “black bag exception”. According to the DEA website Q&A citing case law, this exception allows “a physician who is registered with DEA to dispense controlled substances at a particular location in a state to travel to other unregistered locations in the same state to dispense controlled substances on an ‘as-needed and random basis’”. However, this exception does not apply if “a physician intends to dispense controlled substances from a particular location several times a week or month, [then] he must first file a separate registration for the location” (that is, it does not apply to an anesthesia provider who routinely works with given locations).
Per these DEA regulations, anesthesia providers cannot bring controlled substances to individual locations on a routine basis. Each location must order and store its own stock of controlled substances using the DEA registration of a provider who practices out of the location.
Additionally, controlled substances must be appropriately stored as per both DEA and QUAD A requirements. Controlled substances must be maintained onsite by appropriate facility staff, this includes DEA4 and QUAD A required logging of controlled substances.
Please feel free to contact the QUAD A Clinical Team at standards@quada.org with any clinical questions or concerns.
