Ala. Admin. Code r. 680-X-2-.41
Current through Register Vol. 43, No. 1, October 31, 2024
Section 680-X-2-.41 - Pharmacy Services Permit(1) The Board may issue on a case by case basis a Pharmacy Service Permit for the limited purpose of allowing pharmacists and pharmacy technicians to provide pharmacy services to patients and clients. Nothing in this rule shall limit the board's ability to issue any Pharmacy Service Permit the Board deems appropriate.(2) The Board has determined that, at a minimum, the holder of a Pharmacy Service Permit must designate a Supervising Pharmacist, on site, who is responsible for ensuring that the processes and compliance standards are maintained within limits set by the Board for the permit holder.(3) Nothing in this rule restricts the Board from setting pharmacist and technician ratios.(4) Nothing in this rule shall authorize any individual to perform any activity beyond their scope of practice pursuant to any license or registration issued to them.(5) In the event the application for a Pharmacy Services Permit is by a non-resident pharmacy, in addition to the requirements set out in Paragraphs (1) through (4) above, if applicable, the applicant must comply with the following requirements: (a) Complete an application furnished by the Board and be issued the referenced permit. Any application which is not full and complete will not be processed.(b) Pay the fee set out in Code of Ala. 1975, § 34-23-30.(c) The Pharmacy Services Permit issued by the Board shall become void on December 31st of even numbered years unless renewed in compliance with the Code of Ala. 1975, § 34-23-30.(d) Submit documentation from the applicant's home state verifying any applicable license or permit is valid and in good standing.(e) Designate a resident agent in Alabama for service of Process. The failure to include this information shall result in the denial of the application(f) In the event the applicant will be involved or participate in any remote order processing and not actually shipping, mailing or delivering any drug from its location to a citizen in this State, there shall also be compliance with the following: 1. All statutory and regulatory requirements of the State of Alabama relating to controlled substances, including those that are difference from federal law or regulation.2. All the statutory and regulatory requirements of the State of Alabama regarding drug product selection laws.3. All Board of Pharmacy requirements for data submission related to volumes of orders processed as specified at the time of approval.(g) Submission with the application a policy and procedure manual for Board approval which must, at a minimum, include the following:2. On-Call Pharmacist. For the protection of patients, when orders are being processed remotely and no pharmacist is onsite at the resident Pharmacy, a pharmacist must be on-call to respond to situations that arise that cannot be addressed through remote services, such as patient needing a specific medication which is not available until the resident Pharmacy opens, or a healthcare provider urgently needing information that cannot be provided by the pharmacists performing remote order processing.3. Procedures to be followed in case of downtime.4. The system to be used to identify and respond to medication errors arising from mistakes from remote order processing.5. The system to be used to insure initial and ongoing quality of remote order processing.6. The means by which compliance with HIPAA requirements will be met.(h) Designate a supervising pharmacist who shall be responsible for ensuring compliance with this rule and all applicable laws and rules.(i) Compliance with any other requirement deemed necessary by the Board, to include but not limited to required technician to pharmacist ratios.Ala. Admin. Code r. 680-X-2-.41
New Rule: Filed October 1, 2012; effective November 5, 2012; Amended: Filed November 25, 2013; effective December 30, 2013.Author: Kenny Sanders, R.Ph., President
Statutory Authority:Code of Ala. 1975, § 34-23-92.