Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For purposes of this chapter, the following definitions
				apply:
"Anticipatory compounding"
means the
				compounding of preparations in advance of the pharmacy's receipt of
				patient-specific prescriptions.
"Batch preparation compounding"
means
				anticipatory compounding, compounding preparations intended for multiple
				disbursements, or compounding preparations in a multiple-dose container for
				administration to more than one patient.
"Beyond-use date"
means the date after which a
				compounded preparation should not be used, determined from the date that the
				preparation is compounded.
"Bulk drug substance"
means any substance that
				is represented for use in a drug and that, when used in the manufacturing,
				processing, or packaging of a drug, becomes an active ingredient or a finished
				dosage form of the drug. The term does not include intermediates used in the
				synthesis of such substances.
"Compounding"
means the combining, mixing,
				diluting, pooling, flavoring, or otherwise altering of a drug or bulk drug
				substance to create a drug. Compounding includes the preparation of drugs or
				devices in which all bulk drug substances and components are nonprescription
				products. Compounding does not include the use of a flavoring agent to flavor a
				drug pursuant to rule
				657-20.13 (124,126,155A), nor
				does it include mixing or reconstituting a drug according to the product's
				manufacturer label.
"FDA"
means the Food and Drug Administration
				of the U.S. Department of Health and Human Services.
"Flavoring agent"
means a therapeutically
				inert, nonallergenic substance consisting of inactive ingredients that is added
				to a drug to improve the drug's taste and palatability.
"NABP information sharing network"
means the
				information sharing network developed by the National Association of Boards of
				Pharmacy that collects, assesses, and allows review and sharing of pharmacy
				compounding information as described in the Memorandum of Understanding
				Addressing Certain Distributions of Compounded Human Drug Products between the
				board and the United States Food and Drug Administration.
"Office use"
means that a compounded product
				has been prepared and distributed to a practitioner for administration to a
				patient by the practitioner in the course of the practitioner's professional
				practice. A compounded product distributed to a practitioner for "office use"
				shall not require a patient-specific prescription and may not be further
				distributed to another practitioner or dispensed to a patient for
				self-administration, except as provided in subrule 20.15(2).
"Outsourcing facility"
or
"facility"
means any compounding facility that is registered
				as an outsourcing facility, as defined in
				21 U.S.C. Section
				353b, that distributes sterile compounded
				human drug products without a patient-specific prescription to an authorized
				agent or practitioner in this state.
"USP"
means United States
				Pharmacopeia.