Standards for Pharmacist/Pharmacies Compounding Drug Products
Pharmacists may compound drugs in very limited quantities prior to receiving a valid prescription for an individual based on past routine prescribing patterns.
The patient and prescriber must authorize the use of a compounded product if substituted for a commercially available product. The prescriber's authorization is in addition to signing the substitution permitted side of the written prescription, or advising the substitution when a verbal prescription is issued. The prescriber must document the authorization on the prescription or in the patient's medication record.
Drugs/substances used for compounding must meet official compendia requirements.
The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing.
Pharmacists/pharmacies 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.
Records and reports related to compounding procedures or other records required by chapter 246-945 WAC must be retained for at least two years. This is consistent with all prescription records (WAC 246-945-020).
All records must be readily available at the pharmacy/establishment for authorized inspection during the retention period. As part of the inspection, the records are subject to photocopying or other means of reproduction.
Compounding records may be kept either in its original format or as true copies, such as photocopies, microfilm, microfiche or other accurate reproductions of the original records.
