Monday, December 31, 2012
Porposed Rules in Jan. 2013 Delaware--Include Compounding for Office Use
.1.6 Compounding is the responsibility of the pharmacist. All compounding must be in compliance with FFDCA Section 503A and any regulations promulgated by FDA concerning compounding pertaining to this section. The pharmacist may utilize the assistance of a certified pharmacy technician under the direct supervision of a pharmacist if:
220.127.116.11 The compounding ingredients are checked by the pharmacist before proceeding with the compounding.
18.104.22.168 Every weight and measurement is checked by the pharmacist before proceeding with the compounding.
22.214.171.124 A log is maintained showing the identity of the person actually compounding the medication and the identity of the pharmacist who has performed each of the checks indicated above for each step of the procedure. If policies and procedures are in place ensuring adequate checks by the pharmacist per regulation, the requirement for a log will be waived.
126.96.36.199 On the order of a practitioner, compounded products may be sold to the practitioner for use in his or her office to administer to individual patients, but not for resale.
To read the entire proposed regulations much of which deal with compounding click here