657—11.3(124,147A,155A) Registration required. In any service program which intends to provide services in or into Iowa that include the administration of controlled substances, the responsible individual shall ensure that each primary program site, regardless of location, is registered with the board pursuant to this rule. The current registration certificate shall be available at the primary program site for inspection and copying by the board, its representative, or any other authorized individual.
	11.3(1) Medical director-based service program. In a medical director-based service program, CSA and DEA registrations shall be obtained for each primary program site. CSA and DEA registrations shall be obtained prior to procurement of any controlled substances for use in the service program. Separate registrations for program substations shall not be required. In a medical director-based service program, the CSA and DEA registrations shall be issued in the name of the service program, shall secondarily name the medical director, and shall be issued for the address of the service program’s primary program site.
	11.3(2) Pharmacy-based service program. In a pharmacy-based service program, the CSA registration shall be issued in the name of the service program and shall secondarily name the provider pharmacy. The CSA registration shall be issued for the address of the service program’s primary program site and shall identify the pharmacist in charge of the provider pharmacy as the individual responsible for the controlled substances at the service program. A pharmacy-based service program that is owned by and physically located at the same address as an Iowa-licensed and -registered hospital may, but is not required to, obtain a separate registration.
	11.3(3) Combination pharmacy-based and medical director-based service program. In a service program that is a combination of pharmacy-based and medical director-based and both the pharmacy and medical director provide controlled substances, each provider of controlled substances shall maintain a CSA registration with the board as provided by this rule. A medical director-based program shall also maintain a federal DEA registration as provided by this rule.
	11.3(4) Change of address of registered primary program site. A registrant shall apply to change the address of the registered primary program site by submitting a completed application and fee as provided in 657—subrule 10.9(2).
	11.3(5) Discontinuation of medical director in a medical director-based service program. If a medical director intends to terminate a written agreement with a service program pursuant to rule 657—11.5(124,147A,155A), the medical director shall provide written notification to the board at 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309, pursuant to 657—subrule 10.11(6), to cancel the registration, including the effective date of the termination of the agreement. The registration certificate shall be returned to the board no later than ten days following the effective date of the termination of the agreement.
[ARC 9786B, IAB 10/5/11, effective 11/9/11; ARC 3101C, IAB 6/7/17, effective 7/12/17; ARC 3637C, IAB 2/14/18, effective 3/21/18]