- (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.
Added at 41 Ok Reg, Number 22, effective 8-11-24