RULE 657-20.2 - Definitions

RULE 657-20.2. Definitions

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.

"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.

"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.

(Amended by IAB October 14, 2015/Volume XXXVIII, Number 08, effective 11/18/2015 Amended by IAB June 8, 2016/Volume XXXVIII, Number 25, effective 7/13/2016 Amended by IAB August 2, 2017/Volume XL, Number 3, effective 9/6/2017)

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