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.
See
rules in progress page for more information. Quoted from
Washington State Board of Pharmacy
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