Pharmacy Compounding Standards
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.
- 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.
- Records and Reports related to Compounding Procedures or other records required by Chapter 246-878 WAC must be retained for at least two years. This is consistent with all prescription records (WAC 246-869-100).
- 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.