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Montana News: New and Amended Board of Pharmacy Rules Effective July 1, 2006
Reprinted from the October 2006 Montana Board of Pharmacy Newsletter.
The following is a summary of the new rules that went into effect on July 1, 2006. For a complete listing, visit the Board of Pharmacy Web site www.pharmacy.mt.gov.
Registration of Ambulatory Surgical Facilities: This new rule states that the Board shall annually register and inspect all ambulatory surgical facilities in Montana, regardless of pharmacy status. In ambulatory surgical facilities without an on-site pharmacy, drug distribution must be directed by a physician or a Montana-licensed consulting pharmacist who is responsible for the security, storage, and distribution of drugs within the facility.
Inactive Pharmacist License: This new rule allows a pharmacist to obtain an inactive license through a written request to the Board of Pharmacy. The annual renewal fee for the inactive pharmacist license is $25.
Remote Telepharmacy Operation: This new rule allows for a remote telepharmacy site to be connected to its parent pharmacy via computer, video, and audio link. A site cannot be licensed as a remote telepharmacy if it is located within a 10 mile radius of an existing pharmacy. A remote telepharmacy site must be manned by a registered pharmacy technician in good standing. The remote telepharmacy site is considered to be under the personal charge of the pharmacist at the parent pharmacy. The operation of the remote telepharmacy shall comply with all the requirements of pharmacy rules and statutes of Montana. If controlled substances (CS) are dispensed or handled, both the remote telepharmacy site and the parent pharmacy must be registered with Drug Enforcement Administration (DEA) and must obtain separate DEA license numbers. No prescription medication may be released to a patient until approved by a pharmacist in person or via the computer, video, and audio link. Monthly inspections of the remote telepharmacy site are required to be completed by the pharmacist at the parent pharmacy or that person’s designee, and those reports must be available for review for the Board of Pharmacy inspector during a Board inspection.
Remote Telepharmacy Dispensing Machine Sites: This new rule is a variant of the Remote Telepharmacy rule wherein the telepharmacy site utilizes both a pharmacy technician and a computerized dispensing machine at the remote site.
Central Filling by Hub Pharmacies: This new rule will allow prescriptions to be filled at either a remote pharmacy or at a central hub pharmacy and then transferred securely back to the remote pharmacy. Both the central hub pharmacy and the remote pharmacy must be staffed by licensed pharmacists. A pharmacist shall offer patient counseling at either pharmacy site.
The following is a summary of the amendments to existing rules that went into effect on July 1, 2006. For a complete listing, please visit the Board of Pharmacy Web site at www.pharmacy.mt.gov.
Change in Address and/or Employment 24.174.403: A licensee shall notify the Board in writing within 10 days of any change in employment, and/or any change of business or personal address.
Transfer of Prescriptions 24.174.514: The rule for transfer of prescriptions was amended to address procedures for both the manual and electronic transfer of prescription information. Since the procedures differ in several ways, manual and electronic methods of prescription transfer have been separated into two distinct sections of the rule.
Noninstitutional Collaborative Practice Requirements 24.174.524: Collaborative practice agreements approved by an institutional committee, such as a Pharmacy and Therapeutics Committee that will be used solely for inpatients, do not require the approval of the Board of Pharmacy.
Tasks and Functions af a Pharmacy Technician 24.174.705: This rule was amended to allow a pharmacy technician to act as an agent in charge of the pharmacy when a registered pharmacist is not physically present. The technician may not perform duties that require the professional judgment of a pharmacist, and the technician may not be left in charge of the pharmacy for more than 30 minutes.
Ratio of Pharmacy Technicians to Supervising Pharmacists 24.174.711: This rule was amended to allow a pharmacist to supervise no more than three technicians at any time. If a pharmacy desires more than three technicians to work under the supervision of one pharmacist, the pharmacy shall obtain prior written approval of the Board.
Security of a Pharmacy 24.174.814: This rule was amended to require all pharmacies to maintain and reconcile a perpetual inventory of Schedule II CS. Many pharmacies already engage in this safety practice, which allows for the earliest detection of errors or diversion.
Wholesale Drug Distribution Licensing 24.174.1201: This rule was amended to require a wholesale distributor of prescription drugs to license each separate facility where drugs are stored or distributed.
