(e) ophthalmic drops and ointments; and (f) tissue implants. (16) ‘Compounding aseptic containment isolator’ or ‘CACI’ means a completely enclosed isolating cabinet that makes use of airtight glove ports designed to protect the user from exposure to airborne drugs and other agents during the compounding and material transfer processes. A CACI also provides an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur in a CACI unless the air is first passed through a HEPA minimum, microbial retentive filter system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Where volatile hazardous drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation. (17) ‘Compounding aseptic isolator’ or ‘CAI’ means a completely enclosed isolating cabinet that makes use of airtight glove ports designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer process. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a HEPA minimum, microbial retentive filter. A CAI is primarily used for nonhazardous drug preparations. (818) ‘Confidential information’ means information maintained in a patient’s records or which is communicated to a patient as part of patient counseling, which is privileged and may be released only to the patient, to those practitioners and pharmacists where, in the pharmacist’s professional judgment, release is necessary to protect the patient’s health and well being, and to other persons or governmental agencies authorized by law to receive such confidential information. (19) ‘Critical site’ means an opening that provides a direct pathway between a CSP and the environment or any surface coming in contact with the preparation or environment. (9) ‘Cytotoxic agent’ means a drug that has the capability of killing living cells. (1020) ‘Deliver’ or ‘delivery’ means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for consideration. (1121) ‘Designated agent’ means a person employed by an authorized practitioner to transmit, either orally or electronically, a prescription drug order on behalf of the authorized practitioner to the pharmacist. The authorized practitioner accepts the
(a) the identity, physical and chemical characteristics, physical and health hazards, primary routes of entry, exposure limits of the chemical; (b) whether the chemical is a carcinogen; (c) precautions for safe handling and use of the chemical; (d) control measures; (e) emergency and first aid procedures; (f) the latter of the date the MSDS was prepared or last modified; and (g) the name, address, and telephone number of the manufacturer, importer, or employer who distributes the MSDS. (54) ‘Mediafill test’ means a test to evaluate the aseptic technique of: (a) compounding personnel; (b) a process to ensure that the process used can produce sterile preparation that has no microbial contamination. (3155) ‘Medical order’ means a lawful order of a practitioner which may or may not include a prescription drug order. (56) ‘Negative pressure’ means a room or device that is at a lower pressure than adjacent space; the air flow moves into the room or device. (3257) ‘Nonprescription drug’ means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws of this State and the federal government. (3358) ‘Nonresident pharmacy’ means a pharmacy located outside this State. (3459) ‘Parenteral’ means a sterile preparation of drugs for injection through one or more layers of the skin. (3560) ‘Patient counseling’ means the oral or written communication by the pharmacist to a patient or caregiver providing information on the proper use of drugs and devices. (3661) ‘Permit consultant pharmacist’ means a pharmacist licensed in this State who acts as a consultant for a permit holder other than a pharmacy or institution. (3762) ‘Person’ means an individual, soleproprietorship, corporation, partnership, association, or any other legal entity including government. (63) ‘Personal protective equipment’ or ‘PPE’ means a gown, glove, mask, hair cover, shoe cover, eye shield, and similar items intended to protect the compounder from hazards and minimize particle shedding.
(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