Okla. Admin. Code § 535:15-10-1.1

Current through Vol. 42, No. 4, November 1, 2024

Section 535:15-10-1.1 - Preparation of compounded drug products for over-the-counter (OTC) sale

(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.

Okla. Admin. Code § 535:15-10-1.1

Adopted by Oklahoma Register, Volume 41, Issue 22, August 1, 2024, eff. 8/11/2024