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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 535:15-10-9. Labeling
Latest version.
- (a) If a component is transferred from the original container to another (e.g., a powder is taken from the original container, weighed, placed in, and stored in another container) the new container shall be identified with the:(1) Component name,(2) Lot and BUD if available,(3) Strength and/or concentration, and;(4) Weight or measure(b) Preparations prepared in anticipation of a prescription prior to receiving a valid prescription should not be an inordinate amount.(1) A regularly used amount should be prepared based on a history of prescriptions filled by the pharmacy.(2) These preparations shall be labeled or documentation referenced with the:(A) Complete list of ingredients or preparation name and reference,(B) Preparation date,(C) Assigned BUD:(i) Based on published data, or;(ii) Appropriate testing, or;(iii) USP-NF standards.(D) Specific storage conditions dictated by composition and stability shall be specified (refrigerator, freezer etc), except where clean dry area is dictated, and;(E) Batch or lot number.(c) Upon the completion of the drug compounding operation, the pharmacist shall examine the preparation for correct labeling.(d) The containers and closures shall be of suitable material so as not to alter the quality, strength, or purity of the compounded drug.(e) The outpatient prescription label shall contain the following:(1) Patient name,(2) Prescriber's name,(3) Name & address of pharmacy,(4) Directions for use,(5) Date filled,(6) BUD & storage (may be auxiliary labels), and;(7) An appropriate designation that this is a compounded prescription, such as "Compounded Rx"unless the product is a radiopharmaceutical prepared from an FDA approved commercially manufactured radiopharmaceutical drug. In such case labeling requirements can be found in 535:15-17.