- Hot Topic: Pharmacist/Pharmacy Compounding Standards
During the past few months, we have been following the New England Compounding Center meningitis outbreak and subsequent public health issues related to pharmacy compounding. To date, 34 people have died and 490 injured nationwide. NECC surrendered its license in several states, including its home state of Massachusetts.
We strongly encourage Washington State pharmacies and pharmacists that engage in the practice of compounding to review Chapter 246-878 WAC. The rule defines compounding as the act of combining two or more ingredients in the preparation of a prescription. The rules go on to establish the conditions by which a pharmacist can compound drug products. More pharmacist/pharmacy compounding standards information.
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.