Okla. Admin. Code § 535:15-10-62

Current through Vol. 42, No. 7, December 16, 2024

Section 535:15-10-62 - 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:

(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".

Okla. Admin. Code § 535:15-10-62

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

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.