Oklahoma Administrative Code
Title 535 - Oklahoma State Board of Pharmacy
Chapter 15 - Pharmacies
Subchapter 10 - Good Compounding Practices
Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS
Section 535:15-10-62 - Labeling

Universal Citation: OK Admin Code 535:15-10-62

Current through Vol. 42, No. 1, September 16, 2024

(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 beyond-use date:
(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 preparation operation, the pharmacist shall examine the preparation for correct labeling.

(d) 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) Beyond use date & storage (may be auxiliary labels), and;

(7) An appropriate designation that this is a compounded prescription, such as "Compounded Rx".

Added at 26 Ok Reg 2276, eff 7-1-09

Disclaimer: These regulations may not be the most recent version. Oklahoma may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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