Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.41 - Pharmacy Services Permit

Current through Register Vol. 42, No. 9, June 28, 2024
(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:
1. Hours of operation.
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.