(c) Pharmacists shall receive, store, or use drug substances for compounding that meet official compendia requirements, or of a chemical grade in one of the following categories: chemically pure (CP), analytical reagent (AR), American Chemical Society (ACS), or, if other than this, drug substances that meet the accepted standard of the practice of pharmacy;. (d) Pharmacists may compound drugs before receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/patient/practitioner relationship, for all such products compounded at the pharmacy as required by the Board of Pharmacy; A compounder shall first attempt to use components manufactured in an FDAregistered facility. When components cannot be obtained from an FDAregistered facility, a compounder shall use his professional judgment in selecting an acceptable and reliable source and shall establish purity and safety by reasonable means, to include Certificate of Analysis, manufacturer reputation, and reliability of source. (e) For components that do not have expiration dates assigned by the manufacturer or supplier, a compounder shall label the container with the date of receipt and assign a conservative expiration date, not to exceed three years after receipt of the component based on the nature of the component and its degradation mechanism, the container in which it is packaged, and the storage conditions. (ef) Pharmacists may not offer compounded medications to other pharmacies for resale; however, pharmacists may compound products preparations based on an order from a practitioner for use by practitioners for patient use administration to a patient in institutional or office settings. Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services, e.g., chemicals, devices, and information, when requested; however, they may not solicit business by promoting to compound specific drug products, e.g., like a manufacturer; (fg) The compounding of legend drugs in anticipation of receiving prescriptions without a historical basis or the distribution of compounded products preparations without a patient/practitioner/pharmacist relationship is considered manufacturing. (h) Physicians who administer compounded medications in an office or licensed ambulatory surgical facility setting shall be allowed to order and purchase those medications from the
(c) Pharmacists shall receive, store, or use drug substances for compounding that meet official compendia requirements, or of a chemical grade in one of the following categories: chemically pure (CP), analytical reagent (AR), American Chemical Society (ACS), or, if other than this, drug substances that meet the accepted standard of the practice of pharmacy;. (d) Pharmacists may compound drugs before receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/patient/practitioner relationship, for all such products compounded at the pharmacy as required by the Board of Pharmacy; A compounder shall first attempt to use components manufactured in an FDAregistered facility. When components cannot be obtained from an FDAregistered facility, a compounder shall use his professional judgment in selecting an acceptable and reliable source and shall establish purity and safety by reasonable means, to include Certificate of Analysis, manufacturer reputation, and reliability of source. (e) For components that do not have expiration dates assigned by the manufacturer or supplier, a compounder shall label the container with the date of receipt and assign a conservative expiration date, not to exceed three years after receipt of the component based on the nature of the component and its degradation mechanism, the container in which it is packaged, and the storage conditions. (ef) Pharmacists may not offer compounded medications to other pharmacies for resale; however, pharmacists may compound products preparations based on an order from a practitioner for use by practitioners for patient use administration to a patient in institutional or office settings. Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services, e.g., chemicals, devices, and information, when requested; however, they may not solicit business by promoting to compound specific drug products, e.g., like a manufacturer; (fg) The compounding of legend drugs in anticipation of receiving prescriptions without a historical basis or the distribution of compounded products preparations without a patient/practitioner/pharmacist relationship is considered manufacturing. (h) Physicians who administer compounded medications in an office or licensed ambulatory surgical facility setting shall be allowed to order and purchase those medications from the
497_20170302.docx