Okla. Admin. Code § 535:15-10-53

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

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.

(1) The unavailability of such drug product must be documented prior to compounding.

(2) This or similar documentation must be available when requested by the Board.

(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.

Okla. Admin. Code § 535:15-10-53

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.