Okla. Admin. Code § 535:15-10-9
Current through Vol. 42, No. 4, November 1, 2024
Section 535:15-10-9 - Labeling(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: (2) Lot and BUD if available,(3) Strength and/or concentration, and;(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,(C) Assigned BUD: (i) Based on published data, or;(ii) Appropriate testing, or;(D) Specific storage conditions dictated by composition and stability shall be specified (refrigerator, freezer etc), except where clean dry area is dictated, and;(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: (3) Name & address of pharmacy,(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.Okla. Admin. Code § 535:15-10-9
Added at 17 Ok Reg 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff 7-1-09Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.