Oklahoma Administrative Code
Title 535 - Oklahoma State Board of Pharmacy
Chapter 15 - Pharmacies
Subchapter 10 - Good Compounding Practices
Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS
Section 535:15-10-1.1 - Preparation of compounded drug products for over-the-counter (OTC) sale

Universal Citation: OK Admin Code 535:15-10-1.1

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

(a) A pharmacist licensed by the Oklahoma State Board of Pharmacy may, in accordance with state and federal laws and rules, prescribe non-prescription OTC drugs for the purpose of compounding for a known patient need.

(b) The compounded product shall not contain an ingredient which exceeds recommended strengths and doses for over-the-counter drugs.

(c) The finished compounded OTC product shall not be one for which a prescription is required.

(d) The compounded OTC product shall be labeled with:

(1) Patient name,

(2) Date,

(3) Product name,

(4) Name of all ingredients,

(5) Strength or quantity of all active ingredients,

(6) Package size,

(7) Directions for use,

(8) Use by date,

(9) Name, address, and telephone number of the pharmacy,

(10) Ancillary and cautionary instructions if needed,

(11) Requirements for proper storage, and

(12) An appropriate designation that this is a compounded nonprescription product, such as "Compounded OTC"

(e) The product shall be sold directly to the consumer only after professional interaction or consultation between a pharmacist and a consumer.

(f) The product may be prepared in advance in reasonable amounts in anticipation of estimated needs.

(g) The product shall not be sold to other pharmacies or vendors for resale.

(h) The product shall be stored within the prescription department.

(i) Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of an available FDA-approved drug product is generally prohibited unless patient therapy is compromised.

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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