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Title 10 MARYLAND DEPARTMENT OF HEALTH

Subtitle 34 BOARD OF PHARMACY

Chapter 34 Pharmacy Technicians

Authority: Health-Occupations Article, §§12-205, 12-206, 12-315—12-317, 12-319, 12-320, 12-403, 12-505, 12-707, and 12-6B-01—12-6B-14, Annotated Code of Maryland

Title 10, Subtitle 34, Chapter 34:

.01 Scope.

This chapter applies to applicants for registration as pharmacy technicians and to registered pharmacy technicians.

.02 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Board” means the State Board of Pharmacy.

(2) Compounding.

(a) “Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device:

(i) As the result of a practitioner’s prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice; or

(ii) For the purpose of, or incident to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device.

(b) “Compounding” includes the preparation of drugs or devices in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns.

(3) Delegated Pharmacy Act.

(a) “Delegated pharmacy act” means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter.

(b) “Delegated pharmacy act” does not include:

(i) An act within the parameters of a Drug Therapy Management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland;

(ii) The administration of an influenza vaccination in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland, or this title;

(iii) The delegation of a pharmacy act by a registered pharmacy technician, pharmacy student, or pharmacy technician trainee;

(iv) A pharmacy activity performed by a pharmacy student in accordance with Health Occupations Article, §12-301(b), Annotated Code of Maryland; or

(v) A pharmacy activity performed by an applicant for a license to practice pharmacy, if the applicant does not perform delegated pharmacy acts for more than 10 months.

(4) “Direct supervision” means that a licensed pharmacist is physically available onsite to supervise the performance of delegated pharmacy acts.

(5) “Experiential learning rotation” means a course offered by an Accreditation Council for Pharmacy Education accredited school of pharmacy that is designed to provide pharmacy practice experiences to students seeking the doctor of pharmacy degree.

(6) “National pharmacy technician certification program” means a program approved by a Board-recognized national accrediting body.

(7) “Pharmacy student” means an individual who is enrolled as a student in a school or college of pharmacy approved by the Board or accredited by the Accreditation Council for Pharmacy Education.

(8) “Pharmacy technician trainee” means an individual engaged in a Board-approved pharmacy technician training program.

(9) “Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts.

(10) “Registration” means, unless the context requires otherwise, a registration issued by the Board to perform delegated pharmacy acts under the direct supervision of a licensed pharmacist.

(11) “Supervision” means reviewing the work, guiding and directing the activities, and monitoring the performance of an individual.

.03 Delegated Pharmacy Acts.

A. A pharmacy technician may not:

(1) Represent themselves as a pharmacist;

(2) Dispense prescription medications when the pharmacist is not in the pharmacy;

(3) Be present in the pharmacy when the pharmacist is not physically available onsite;

(4) Provide information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices;

(5) Delegate a pharmacy act that was delegated to the pharmacy technician or individual engaging in a Board-approved technician training program;

(6) Act within the parameters of a therapy management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland;

(7) Administer an influenza vaccination in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland;

(8) Provide the final verification for accuracy, validity, completeness, or appropriateness of a filled prescription or medication order;

(9) Make decisions that require a pharmacist’s professional judgment;

(10) Clinically evaluate the patient’s profile relative to the pharmaceuticals that have been or will be dispensed;

(11) Consult with the patient concerning the utilization of their pharmaceuticals;

(12) Accept or transcribe new prescriptions;

(13) Give or accept a transferred prescription for controlled dangerous substances;

(14) Accept a transferred prescription;

(15) Independently compound prescriptions;

(16) Administer medications; or

(17) Accept the return of prescription drugs or devices directly from a patient.

B. A pharmacy technician shall be clearly identified as such to the public.

C. When performing tasks in the prescription area, a pharmacy technician shall maintain proper:

(1) Sanitation;

(2) Hygiene;

(3) Biohazard precautions; and

(4) Infection control.

.04 Registration Requirements.

A. An applicant currently certified by a national pharmacy technician certification program shall:

(1) Submit to the Board a signed completed application on a form provided by the Board;

(2) Submit to the Board evidence of current certification by a national pharmacy certification program;

(3) Pay a fee as set forth in COMAR 10.34.09; and

(4) Submit a request for a State Criminal History Records check.

B. An applicant that does not qualify under §A of this regulation shall:

(1) Submit to the Board a signed completed application on a form provided by the Board;

(2) Be 17 years old or older;

(3) Meet the following educational requirements:

(a) Be a high school graduate or have attained a high school equivalency diploma;

(b) Be enrolled and in good standing at a high school; or

(c) Meet the requirements of §C of this regulation;

(4) Provide satisfactory proof to the Board of the applicant’s successful completion of a pharmacy technician training program approved by the Board that:

(a) Is no longer than 6 months duration; and

(b) Includes 160 hours of work experience;

(5) Pass an examination approved by the Board as set forth in Regulation .06 of this chapter;

(6) Pay a fee as set forth in COMAR 10.34.09; and

(7) Submit a request for a State Criminal History Records check.

C. An applicant who does not meet the requirements of §A or B of this regulation shall:

(1) Submit to the Board a signed application on a form provided by the Board;

(2) Comply with the age requirements as set forth in §B of this regulation;

(3) Provide written verification from the pharmacy permit holder that the applicant has worked in the pharmacy area of a pharmacy operated by the same pharmacy permit holder continuously since January 1, 2006;

(4) Provide written verification from the pharmacist who has supervised the applicant for at least 6 months that the applicant has performed competently;

(5) Pay a fee as set forth in COMAR 10.34.09; and

(6) Submit a request for a State Criminal History Records check.

D. The Board of Pharmacy shall provide the pharmacy technician with a registration card and pocket identification card upon initial registration and renewal.

.05 Pharmacy Students — Exemptions.

A. Pharmacy students who are practicing in a pharmacy as part of a school of pharmacy sanctioned experiential learning rotation are not subject to the registration requirements of Regulation .04 of this chapter.

B. Pharmacy students who are currently completing the first year of a professional pharmacy education program and are not in a school of pharmacy sanctioned experiential learning rotation may perform delegated pharmacy acts provided that the pharmacy student:

(1) Submits to the Board a signed completed application for exemption from the registration requirements of Regulation .04 of this chapter; and

(2) Provides verification of enrollment and good standing at an accredited school of pharmacy.

C. A pharmacy student may begin work under this exemption upon compliance with §B of this regulation.

D. An exemption from registration granted under this regulation is effective only during the first year of the pharmacy student’s professional pharmacy education program.

E. Pharmacy students granted an exemption from registration under this regulation are not subject to renewal requirements as set forth in Regulation .08 of this chapter.

F. A pharmacy student granted an exemption from registration under this regulation shall perform delegated pharmacy acts under the direct supervision of a licensed pharmacist and in accordance with Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter.

.06 Standards for Pharmacy Technician Training Programs.

A. Minimum Standards.

(1) Pharmacy technician training programs shall, at a minimum, cover the following areas of pharmacy practice:

(a) Roles and responsibilities of the pharmacy technician;

(b) Knowledge of prescription medications;

(c) Knowledge of strengths or dose, dosage forms, physical appearance, routes of administration, and duration of drug therapy;

(d) The dispensing process;

(e) Pharmaceutical calculations;

(f) Interacting with patients;

(g) Third party prescriptions;

(h) Extemporaneous compounding;

(i) Requirements and professional standards for:

(i) Preparing;

(ii) Labeling;

(iii) Dispensing;

(iv) Storing;

(v) Prepackaging;

(vi) Distributing; and

(vii) How medications are administered;

(j) Confidentiality;

(k) Drugs used to treat the following indications:

(i) Hypertension;

(ii) Antihyperlipidemia;

(iii) Diabetes mellitus;

(iv) Arthritis;

(v) Gastrointestinal disorders;

(vi) Asthma and allergy; and

(vii) Infectious diseases;

(l) Federal and State laws and regulations governing the practice of pharmacy; and

(m) Knowledge of special dosing considerations for pediatric and geriatric populations.

(2) Pharmacy technician training programs may be offered by:

(a) Pharmacy employers;

(b) Nationally recognized pharmacy technician training programs;

(c) Accredited educational institutions pharmacy technician programs;

(d) Pharmacy technician programs approved by the Maryland State Department of Education and the Maryland Higher Education Commission; and

(e) Pharmacy technician training programs offered by the U.S. Armed Forces.

(3) Training programs may not be longer than 6 months.

(4) Training programs shall include 160 hours of work experience.

B. Board Approval of Pharmacy Technician Training Programs.

(1) A program shall submit an application on a form provided by the Board.

(2) A program shall provide the Board with the course outline and any other information requested by the Board.

(3) Any changes in course content shall require notification and approval from the Board.

(4) The Board shall have final approval of a pharmacy technician training program.

(5) The Board may withdraw approval of a program if the Board finds that the program is in violation of this chapter.

(6) The Board shall approve pharmacy technician training programs offered by the U.S. Armed Forces.

.07 Standards for Examination Approval.

The Board shall approve examinations which have:

A. Content criteria set forth in Regulation .06 of this chapter;

B. A minimum of 100 multiple choice questions;

C. Sufficient additional questions so that the examination questions may be rotated twice a year; and

D. A passing score of 75 percent or higher.

.08 Renewal Requirements.

A. The pharmacy technician’s registration shall expire on the last day of the birth month following 1 year after initial registration.

B. Following initial registration, a pharmacy technician’s registration:

(1) Expires on the date set by the Board unless it is renewed for an additional term; and

(2) May not be renewed for a term longer than 2 years.

C. At least 1 month before the registration expires, the Board shall issue a renewal notice to the pharmacy technician registrant that states:

(1) The date on which the current registration expires;

(2) The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the registration expires; and

(3) The amount of the renewal fee.

D. The registrant may renew the registration for an additional term of 2 years if the registrant:

(1) Otherwise is entitled to be registered;

(2) Pays to the Board a renewal fee set forth in COMAR 10.34.09; and

(3) Submits to the Board:

(a) A renewal application on the form that the Board requires; and

(b) Satisfactory evidence of compliance with the continuing education requirements set forth in Regulation .09 of this chapter.

.09 Continuing Education.

A. Requirements.

(1) A pharmacy technician registered to practice in Maryland shall earn 20 hours of approved continuing pharmaceutical education within the 2-year period immediately preceding the registrant’s renewal application.

(2) For the first renewal period during which continuing education is mandatory for a pharmacy technician, the Board of Pharmacy shall require only 10 hours of continuing education requirements.

(3) A pharmacy technician shall:

(a) Attest to the fact that the pharmacy technician has completed the continuing pharmacy technician education requirement on the required form; and

(b) Retain supporting documents for inspection by the Board for 4 years after the date of renewal for which the continuing education credits were used.

B. Accredited Continuing Education Providers.

(1) The following providers are approved for any programs they offer which otherwise qualify for continuing education credit:

(a) Accreditation Council on Pharmaceutical Education (ACPE);

(b) All schools of pharmacy accredited by the American Association of Colleges of Pharmacy (AACP); and

(c) Out-of-State providers approved by a state board of pharmacy.

(2) Procedures for Approval of Additional Programs.

(a) Other providers shall initially request Board approval for individual programs.

(b) An approved program is valid for a 2-year period.

(c) The approved provider shall submit to the Board changes to the program that differ from the initial submission of information for Board approval.

(d) Failure to submit to the Board changes to an approved program may result in the Board withdrawing approval of the program.

(3) Providers of continuing education shall furnish a certificate of completion to participants who qualify that includes the:

(a) Name of the participant;

(b) Name of the provider;

(c) Description of course work;

(d) Number of hours;

(e) Date of completion; and

(f) Program identification number or provider number on the certificate.

C. Miscellaneous.

(1) Credits may not be carried over from one continuing education period to another.

(2) The Board of Pharmacy may grant an exception from the continuing education requirements if the pharmacy technician presents evidence that failure to comply was due to circumstances beyond the pharmacy technician’s control.

(3) Falsifying continuing education records is grounds for disciplinary action under Health Occupations Article, §12-6B-09(2) and (3), Annotated Code of Maryland.

(4) If the Board provides a form for information, the pharmacy technician shall use the form to supply the requested information to the Board.

.10 Reinstatement.

A. A pharmacy technician whose Maryland registration expired less than 2 years before applying for reinstatement shall:

(1) Complete 20 hours of continuing education; and

(2) Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09.

B. A pharmacy technician whose Maryland registration expired more than 2 years before applying for reinstatement, shall:

(1) Complete 20 hours of continuing education;

(2) Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09; and

(3) Pass a Board-approved exam.

.11 Reciprocity.

A. An individual applying to register as a pharmacy technician by reciprocity shall:

(1) Submit to the Board an application on a form approved by the Board;

(2) Pay to the Board the fee set forth in COMAR 10.34.09; and

(3) Submit a request for a State Criminal History Records check.

B. An individual applying to register as a pharmacy technician by reciprocity shall:

(1) Submit to the Board evidence of the following:

(a) Registration in another state under requirements similar to the registration requirements of this chapter; and

(b) Evidence of being in good standing in the state or states of current registration; or

(2) Evidence of having worked as a pharmacy technician in another state for at least 6 months.

Title 10, Subtitle 34, Chapter 35:

.05 Support Personnel.

A. Pharmacy Technicians.

(1) A pharmacist working in an infusion pharmacy may delegate pharmacy acts to a pharmacy technician in accordance with COMAR 10.34.34.

(2) A pharmacy technician working in an infusion pharmacy may not perform delegated pharmacy acts as set forth in COMAR 10.34.34.03.

(3) A pharmacy technician working in an infusion pharmacy shall:

(a) Communicate immediately to the pharmacist reported changes in:

(i) Patient condition;

(ii) Patient medication list; and

(iii) Allergies; and

(b) Obtain pharmacist approval before processing refills.

(4) A pharmacy technician working in an infusion pharmacy may not:

(a) Except as provided in COMAR 10.34.34, accept or transcribe a new or change verbal order from an licensed authorized prescriber of record or the licensed authorized prescriber of record’s agent;

(b) Perform the clinical assessment of a patient;

(c) Communicate clinical matters except as required in §A(3)(a) of this regulations;

(d) Provide therapy-related direction to a patient or caregiver; and

(e) Create a patient care plan specific to a patient’s therapy.

B. Unlicensed Personnel.

(1) Unlicensed personnel working in an infusion pharmacy under the supervision of a pharmacist may perform operational support which the unlicensed personnel have been trained to adequately perform in accordance with COMAR 10.34.21.

(2) Unlicensed personnel shall be appropriately trained to perform the following tasks, as applicable, including but not limited to:

(a) Schedule delivery dates based on;

(i) Patient supply needs;

(ii) Patient or caregiver availability; and

(iii) If applicable, geographic delivery zones;

(b) Create delivery tickets;

(c) Communicate with the infusion nurse or pharmacist concerning supply needs and problems; and

(d) Clean, test, and maintain patient-use equipment.

(3) Unlicensed personnel working in an infusion pharmacy shall refer clinical questions or concerns reported by patients or caregivers immediately to the pharmacist.

(4) Unlicensed personnel may not perform delegated pharmacy acts.