Acquisition of Controlled Substances

by: Duane Tinker

Controlled substances may be acquired only by an individually registered practitioner. They cannot be combined with those acquired under another registration. When multiple practitioners at one location wish to centralize controlled substances, they are allowed to do so under the concept of a “principal practitioner.” Federal regulations in 21 CFR 1301.22(b) allow an individual to administer or dispense as an agent of a principal practitioner, with the principal practitioner being responsible for all controlled substance purchases, security and record keeping.

Under this concept, all controlled substances must be acquired under the registration of the principal practitioner. Receiving records such as invoices, DEA Official Order Forms, receipts for samples, or transfer records must be maintained.

If controlled substances are maintained under separate registrations, the drugs for each registration must be kept physically separate. Records must clearly indicate which registration each supply of drugs is maintained under. Complete records of receiving, inventory and disposition must be maintained for each separate registration.

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As described above, the practitioners have a choice. They may each have their controlled substances stored separately and each maintain their own separate records, or they may delegate a principal practitioner to manage one supply of controlled substances and maintain one set of records under that single practitioner’s registration.

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A former Law Enforcement Officer/ Dental Board investigator Mr. Duane Tinker is the CEO of Dental Compliance Specialists. Mr. Tinker and his compliance specialists provide compliance consulting, auditing and training services for dentists and Dental Service Organizations nationwide on compliance risks including OSHA, HIPAA, Dental Board rules/ regulations, state radiology rules, DEA and state drug regulations, and Medicaid. He often speaks for dental societies and study clubs. Mr. Tinker can be reached at (817) 755-0035 or click here to email.