Minn. R. agency 164, ch. 6800, OPERATION OF PHARMACIES, pt. 6800.3850

Current through Register Vol. 49, No. 24, December 9, 2024

Part 6800.3850 - PHARMACY TECHNICIANS

Subpart 1.Technician registration required.

Pharmacy technicians may be used in performing pharmacy tasks not specifically reserved in this chapter to a licensed pharmacist only when the technician is properly registered with the board. An individual may not, under any circumstances, perform pharmacy tasks as a pharmacy technician prior to being registered as a pharmacy technician according to this part. Registration does not include any determination of the competency of the registered individual.

Subp. 1a.Denial and suspension of registration.

The board may deny, suspend, revoke, refuse to renew, or place conditions and limitations on the registration of a technician for any violation of the rules of the board or the laws of this state, another state, or the United States relating to the practice of pharmacy, prescription drugs, or controlled substances.

Subp. 1b.Registration, renewals.

A. A pharmacy technician registration expires each year on December 31 and shall be renewed annually by filing an application for registration renewal on or before December 1 of each year, together with the fee listed in subpart 1c.

B. Initial registration shall not be prorated.

Subp. 1c.Registration fee, late fee.

A. The fee for an initial registration is the amount established in Minnesota Statutes, chapter 151.

B. The fee for each annual renewal is the amount established in Minnesota Statutes, chapter 151.

C. The fee must be paid at the time when a new application or a renewal application is submitted to the board.

D. Persons required to renew their registration under this part, who file an application which is received by the board after the date on which it is due, must pay a late fee of 50 percent of the renewal fee in addition to the renewal fee.

Subp. 1d.Notifications to board.

A pharmacy technician must report any changes in name, residence, or place of employment to the board within ten days of the change.

Subp. 1e.Identification of technician.

A. A pharmacy technician must wear a name badge while on duty which clearly identifies the person as a "Pharmacy Technician," except when complying with the requirements of United States Pharmacopeia Chapter 797.

B. Pharmacy technicians must not represent themselves as pharmacists in any manner.

Subp. 1f.Posting of registration.

A pharmacy technician shall post the registration most recently issued by the board in a conspicuous place within the pharmacy in which the technician is working. For all pharmacies, this place shall be a place which is readily accessible to the board.

Subp. 1g.Minimum age.

Prior to January 1, 2012, the board shall not register as a pharmacy technician any individual who is less than 16 years of age. Effective January 1, 2012, the board shall not register as a pharmacy technician any individual who is less than 18 years of age. An individual who is less than 18 years of age and who was registered by the board as a pharmacy technician prior to January 1, 2012, may renew registration provided that all other requirements for renewal are met.

Subp. 1h.Education and training requirements.

A. Initial registration. Effective January 1, 2013, the board shall not issue an initial pharmacy technician registration to any individual who does not present the board with evidence of high school graduation or possession of a general educational development certificate equivalent. An individual who is not a high school graduate or who does not possess a general educational development certificate equivalent who was registered by the board prior to January 1, 2013, may renew the individual's registration provided that all other requirements for renewal are met and provided the individual maintains a pharmacy technician registration on an uninterrupted basis. Any individual whose registration lapses for a period of more than one year must meet the registration requirements in effect at the time the individual applies for reinstatement of registration.

B.Renewal of registration. Effective January 1, 2014, the board shall not renew the registration of a pharmacy technician who was initially registered after January 1, 2013, or who was initially registered prior to that date but did not maintain continuous registration, unless the individual provides the board with evidence of completion of one of the following:

(1) a pharmacy technician training program offered by a board-approved, accredited vocational/technical institution or college;

(2) a pharmacy technician training program accredited by a board-approved, national organization that accredits pharmacy technician training programs;

(3) a pharmacy technician training program provided by a branch of the United States armed forces or Public Health Service; or

(4) an employer-based pharmacy technician training program that includes a minimum total of 240 hours on a one-year period to include both theoretical and practical instruction. An employer utilizing such a program must develop and regularly update a technician training manual that must be available for board inspection upon request. The employer must also supply a technician who completes the training program with written evidence of completion. The employer-based pharmacy technician training program must include written guidelines, policies, and procedures that define the specific tasks the technician will be expected to perform. A pharmacy technician who has not completed this training, but is otherwise eligible for renewal of his or her registration, may apply for renewal provided that: less than six months has elapsed between the date of initial registration as a pharmacy technician and the date of the pharmacy technician's first renewal of registration; or the pharmacy technician shows satisfactory evidence of being enrolled in a pharmacy technician training program offered by a board-approved, accredited vocational/technical institution or college, when the program is longer than six months in length.

C.Pharmacy-specific training.Notwithstanding the fact that a technician has completed a training program as specified in item B, it is the responsibility of the pharmacist-in-charge of a pharmacy to ensure that a technician receives adequate training in the tasks performed by technicians working at that pharmacy.

Subp. 2.Permissible duties.

Pharmacy technicians may perform pharmacy tasks not specifically reserved in this chapter to a licensed pharmacist or pharmacist-intern and that do not involve the use of professional judgment.

Subp. 3.Certifying.

Pharmaceutical products prepared or processed, in whole or in part, by a pharmacy technician must be certified for accuracy by a licensed pharmacist, practitioner, or pharmacist-intern as provided for in part 6800.3100, subpart 1, item F, prior to release for patient use.

Subp. 4.Written procedures.

Written procedures for the use of pharmacy technicians in a pharmacy shall be prepared by the pharmacist-in-charge. A copy of the procedures must be given to each technician and a copy must be kept on file in the pharmacy. The written procedures must be made available for inspection by the board upon request. These procedures must comply with the standards in this chapter and will be reviewed for compliance on that basis.

These procedures must indicate in detail the tasks performed by the pharmacy technician; the name, address, and registration number of the pharmacy technician; and the certification steps performed by the licensed pharmacist in verifying the technician's work. Procedures must be updated at least every five years and whenever a significant change in the way in which pharmacy technicians are utilized occurs. The pharmacist-in-charge shall ensure that each technician has reviewed the procedures when the technician is first employed by the pharmacy as a technician and when any substantial changes to the procedures have been made. The pharmacist-in-charge must ensure that proper documentation of training is maintained in the pharmacy for a period of at least two years after the training occurs.

Subp. 5.Supervision.

Pharmacy technicians shall be supervised by a licensed pharmacist stationed within the same work area who has the ability to control and is responsible for the action of the pharmacy technician. The ultimate responsibility for the actions of a pharmacy technician working under a licensed pharmacist's supervision shall remain with the licensed pharmacist.

Subp. 6.Ratios.

The basic ratio of pharmacy technicians to pharmacists on duty in a pharmacy is two technicians to one pharmacist. Specific functions are excepted from the basic ratio as follows:

A. intravenous admixture preparation (parts 6800.7510 to 6800.7530), 3:1;

B. setting up or preparing patient specific prescriptions in unit dose or modified unit dose packaging (part 6800.3750), 3:1;

C. prepackaging (part 6800.3200), 3:1; and

D. compounding (part 6800.3300), 3:1.

Subp. 7.Persons not included.

Personnel used solely for clerical duties such as typing or keyboarding that does not involve prescription data entry, record keeping, filing, billing, and completing sales transactions need not be included when determining compliance with the ratios listed in this part. Personnel used solely for the delivery of filled prescription drug orders need not be included when determining compliance with the ratios listed in this part.

A pharmacist-intern submitting hours toward completion of the 1,600-hour requirement is not considered a pharmacy technician for the purpose of determining the number of pharmacy technicians supervised by a licensed pharmacist.

Subp. 8. [Repealed, 23 SR 1597]

Subp. 9.Unprofessional conduct.

The use of pharmacy technicians in the performance of delegated tasks not included in written procedures may be considered unprofessional conduct on the part of the pharmacist supervising the technician, the pharmacist-in-charge, and the pharmacy technician. Falsification of any documents pertaining to the training of pharmacy technicians shall be considered unprofessional conduct on the part of any pharmacist or pharmacy technician involved in such act.

Minn. R. agency 164, ch. 6800, OPERATION OF PHARMACIES, pt. 6800.3850

9 SR 1656; 18 SR 1145; 23 SR 1597; 25 SR 81; 36 SR 237; L 2012 c 187s 74

Statutory Authority: MS s 151.06; 151.102; 151.12; 151.13; 151.19; 151.25; 151.47; 151.48; 151.49; 214.06