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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 535. Oklahoma State Board of Pharmacy |
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Chapter 15. Pharmacies |
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Subchapter 10. Good Compounding Practices |
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Part 1. GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS |
SECTION 535:15-10-2. Definitions
Latest version.
- The following words or terms, when used in this Subchapter, shall have the following meaning, unless the context clearly indicates otherwise:"Beyond-Use Date (BUD)" means the date and time, as appropriate, after which administration is not to begin of a compounded preparation; and such date is determined from the date the preparation is compounded."Biological Safety Cabinet (BSC)" means a ventilated cabinet for hazardous drugs, personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection meeting USP standards."Compounder" means a compounder is a pharmacist or anyone compounding under the direct supervision of a pharmacist pursuant to a prescription order by a licensed prescriber."Compounding" means compounding as defined in 59 O.S. Section 353.1 et seq."Component" means any ingredient used in the compounding of a drug preparation, including those that may not appear on the labeling of such a preparation."Inordinate Amount" means an amount of compounded drug that exceeds the amount a pharmacy anticipates may be used or dispensed before the BUD of the compounded drug and/or is unreasonable considering the intended use of the compounded drug."Isolator" means a device that is sealed or is supplied with air through a microbially retentive filtration system (HEPA minimum) and may be reproducibly decontaminated."Labeling" means all labels and other written, printed, or graphic matter on an immediate container of an article or preparation or on, or in, any package or wrapper in which it is enclosed, except any outer shipping container. The term 'label'designates that part of the labeling on the immediate container."Manufacturing" means manufacturing as defined in 59 O.S. Section 353.1 et seq."Personal Protective Equipment (PPE)" means items such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical or chemical exposures."Pharmacy Generated Preparations" or "(PGP)" means a medical preparation that is prepared, packaged and labeled in a pharmacy that can be sold by the pharmacy without a prescription."Preparation" means an article compounded in a licensed pharmacy pursuant to the order of a licensed prescriber."Product" means a commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the FDA. Products are accompanied by full prescribing information, which is commonly known as the FDA-approved manufacturer's labeling or product package insert."USP" means "United States Pharmacopeia"