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 535:15-10-53 - General requirements

(a) Compounding a drug preparation 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.

(b) However, in special circumstances a pharmacist may compound an appropriate quantity of a drug that is different from an FDA-approved drug that is commercially available based on documentation provided by the prescribing physician of a patient specific medical need (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available.

(c) Except for those preparations where stability prohibits advanced compounding, all preparations dispensed by the pharmacy shall be in a form ready for administration, except in health care facilities where medications may be provided as demanded by policies and procedures.

(d) Compounding may be for the purpose of, or as an incident to, research, teaching, or chemical analysis.

(e) Compounding includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(f) Reconstitution of commercial products is not considered compounding for the purposes of this subchapter.

(g) Manipulation of commercial available products beyond the manufacturer's instructions or copying commercial products for the reason of non-availability or component specifications would be considered compounding as pertaining to a practitioner / patient / compounder relationship.