Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.7 - Separate Registration for Independent Activities; Coincident Activities

Current through Register Vol. 47, No. 3, July 24, 2024
The following activities are deemed to be independent of each
				other and shall require separate registration. Any person or business engaged
				in more than one of these activities shall be required to separately register
				for each independent activity, provided, however, that registration in an
				independent activity shall authorize the registrant to engage in activities
				identified coincident with that independent activity.
(1)
Manufacturing controlled
			 substances.
A person or business registered to manufacture controlled
			 substances in Schedules I through V may distribute any substances for which
			 registration to manufacture was issued. A person or business registered to
			 manufacture controlled substances in Schedules II through V may conduct
			 chemical analysis and preclinical research, including quality control analysis,
			 with any substances listed in those schedules for which the person or business
			 is registered to manufacture.
(2)
Distributing controlled substances.
This independent activity
			 includes the delivery, other than by administering or dispensing, of controlled
			 substances listed in Schedules I through V. No coincident activities are
			 authorized.
(3)
Dispensing,
			 administering, prescribing, or instructing with controlled substances.
These independent activities include, but are not limited to, prescribing,
			 administering, and dispensing by individual practitioners; dispensing by
			 pharmacies and hospitals; and conducting instructional activities with
			 controlled substances listed in Schedules II through V. A person or business
			 registered for these independent activities may conduct research and
			 instructional activities with those substances for which the person or business
			 is registered to the extent authorized under state law. If an entity that
			 engages in the distribution, administration, dispensing, or storing of
			 controlled substances maintains multiple licenses, such as a hospital that has
			 both inpatient and outpatient pharmacies, a separate registration shall be
			 maintained for each license.
(4)
Conducting research with controlled substances listed in Schedule
			 I.
A researcher may manufacture or import the substances for which
			 registration was issued provided that such manufacture or import is permitted
			 under the federal DEA registration. A researcher may distribute the substances
			 for which registration was issued to persons or businesses registered or
			 authorized to conduct research with that class of substances or registered or
			 authorized to conduct chemical analysis with controlled substances.
(5)
Conducting research with
			 controlled substances listed in Schedules II through V.
A researcher
			 may conduct chemical analysis with controlled substances in those schedules for
			 which registration was issued, may manufacture such substances if and to the
			 extent such manufacture is permitted under the federal DEA registration, and
			 may import such substances for research purposes. A researcher may distribute
			 controlled substances in those schedules for which registration was issued to
			 persons registered or authorized to conduct chemical analysis, instructional
			 activities, or research with such substances, and to persons exempt from
			 registration pursuant to Iowa Code section
			 124.302(3),
			 and may conduct instructional activities with controlled substances.
(6)
Conducting chemical analysis with
			 controlled substances.
A person or business registered to conduct
			 chemical analysis with controlled substances listed in Schedules I through V
			 may manufacture and import controlled substances for analytical or
			 instructional activities; may distribute such substances to persons registered
			 or authorized to conduct chemical analysis, instructional activities, or
			 research with such substances and to persons exempt from registration pursuant
			 to Iowa Code section
			 124.302(3);
			 may export such substances to persons in other countries performing chemical
			 analysis or enforcing laws relating to controlled substances or drugs in those
			 countries; and may conduct instructional activities with controlled
			 substances.
(7)
Importing
			 or exporting controlled substances.
A person or business registered to
			 import controlled substances listed in Schedules I through V may distribute any
			 substances for which such registration was issued.