Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.3 - Registration Required

Current through Register Vol. 47, No. 3, July 24, 2024
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.
(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 in the name of the medical director. 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,
			 a CSA registration shall also be obtained 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.
(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.
(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.
(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).
(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.