(1) Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription, or in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns, pharmacists may compound, for an individual patient, drug products that are commercially available in the marketplace. When a compounded product is to be substituted for a commercially available product, both the patient and also the prescriber must authorize the use of the compounded product. The pharmacist shall document these authorizations on the prescription or in the computerized patient medication record. The prescriber's authorization shall be in addition to signing on the "substitution permitted" side of a written prescription or advising that substitution is permitted when a verbal prescription is issued.

(2) Pharmacists shall receive, store, or use drug substances for compounding prescriptions that meet official compendia requirements. If these requirements can not be met, and pharmacists document such, pharmacists shall use their professional judgment in the procurement of acceptable alternatives.

(3) Pharmacists may compound drugs in very limited quantities prior to receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/patient/prescriber relationship, and provided that they maintain the prescriptions on file for all such products compounded at the pharmacy. The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing.

(4) Pharmacists shall not offer compounded drug products to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a practitioner to administer to an individual patient. Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not solicit business (e.g., promote, advertise, or use salespersons) to compound specific drug products.

(5) The distribution of inordinate amounts of compounded products without a prescriber/patient/pharmacist relationship is considered manufacturing.