5736015 Health, Department of - Notice of Final Rulemaking - For the Registration and Regulation of Pharmacy Technicians
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DEPARTMENT OF HEALTH
NOTICE OF FINAL RULEMAKING
The Director of the Department of Health (“Department”), pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1203.02(14) (2012 Repl.)); Mayor’s Order 98-140, dated August 20, 1998; the Pharmacy Technician Amendment Act of 2012, effective May 1, 2013 (D.C. Law 19-0303; D.C. Official Code §§ 3-1207.51 et seq. (2012 Repl. & 2014 Supp.)), hereby gives notice of the adoption of the following new Chapter 99 (Pharmacy Technicians) of Title 17 (Business, Occupations and Professionals) of the District of Columbia Municipal Regulations (DCMR).
This rulemaking adds a new Chapter 99, which is necessary to require the registration of pharmacy technicians and pharmacy technician trainees, and to regulate the practice of pharmacy technicians and pharmacy technician trainees.
This rulemaking was published in the D.C. Register on July 24, 2015 at 62 DCR 10026. The Department received two comments in response to this notice. The comment received from Kaiser Permanente stated support for the regulations as proposed, and did not recommend any changes. The second comment was an email sent to the Board of Pharmacy from the Therapeutic Research Center. The email contained specific inquiries regarding the approval of pharmacy technician training programs, and did not recommend any changes. Therefore, no changes have been made to the rulemaking.
These final rules will be effective upon publication of this notice in the D.C. Register.
Chapter 99, PHARMACY TECHNICIANS, of Title 17 DCMR, BUSINESS, OCCUPATIONS, AND PROFESSIONALS, is added as follows:
CHAPTER 99 PHARMACY TECHNICIANS
Secs.
9900 General Provisions
9901 Term of Registrations
9902 Registration Requirements for Pharmacy Technicians
9903 Criteria for Approval of Pharmacy Technician Training Programs
9904 Examination Requirements for Pharmacy Technician Training Programs
9905 Registration by Reciprocity
9906 Registration for Pharmacy Technician Trainees
9907 Continuing Education Requirements
9908 Approved Continuing Education Programs and Activities
9909 Continuing Education Credits
9910 Scope of Practice
9911 Other Pharmacy Related Services
9912 Grandfathering
9999 Definitions
9900 GENERAL PROVISIONS
9900.1 This chapter shall apply to applicants for and holders of a registration to practice as a pharmacy technician or pharmacy technician trainee.
9900.2 Chapter 40 (Health Occupations: General Rules) and 41 (Health Occupations: Administrative Procedures) shall supplement this chapter.
9900.3 A registered pharmacy technician shall wear a name tag bearing the title “registered pharmacy technician” and display his or her current registration in a conspicuous place in the pharmacy in which he or she is employed.
9900.4 A pharmacy technician trainee shall not use a title other than pharmacy technician trainee, shall wear a name badge bearing the title “pharmacy technician trainee”, and shall display his or her current registration in a conspicuous place in the pharmacy in which he or she is employed.
9900.5 Consistent with maintaining patient safety, no pharmacist shall supervise more pharmacy technicians and trainees than he or she can safely supervise. The pharmacist shall be fully responsible for the practice of each technician and trainee during the period of supervision and may be subject to disciplinary action for any violation of the act by a technician or trainee he or she supervises.
9901 TERM OF REGISTRATIONS
9901.1 Subject to § 9901.4, a pharmacy technician registration issued pursuant to this chapter shall expire at 11:59 PM of February 28th of each odd-numbered year.
9901.2 A pharmacy technician trainee registration shall expire one year from the date of registration or upon issuance of a pharmacy technician registration, whichever is earlier.
9901.3 A pharmacy technician trainee registration shall not be renewed.
9901.4 If the Director changes the renewal system pursuant to § 4006.3 of Chapter 40 of this title, a pharmacy technician registration issued pursuant to this chapter shall expire at 12:00 midnight of the last day of the month of the birthdate of the holder of the registration or other date established by the Director.
9902 REGISTRATION REQUIRMENTS FOR PHARMACY TECHNICIANS
9902.1 Except as otherwise provided in this subtitle, an applicant applying for a registration to practice as a pharmacy technician shall establish to the satisfaction of the Board that the applicant has successfully:
(a) Obtained a high school diploma or its equivalent, or has passed a Board-approved examination that proves that he or she has achieved competency in the educational skills required to perform the function of a pharmacy technician; and
(b) Obtained a current certification from:
(1) The Pharmacy Technician Certification Board (PTCB);
(2) The National Healthcareer Association (formerly ICPT); or
(3) Another state certifying organization approved by the Board; or
(c) Completed one of the following types of Board approved pharmacy technician training programs, which shall include a Board-approved exam:
(1) A national, regional, or state accredited pharmacy technician training program recognized by the Board;
(2) A pharmacy technician program at a college or university that is accredited by an accrediting body recognized by the Secretary of the United States Department of Education or the Council on Postsecondary Accreditation;
(3) An employer-based pharmacy technician training program recognized by the Board that meets the requirements of § 9903 and includes a minimum of one hundred sixty (160) hours of training within a one (1) year period, including theoretical and practical instruction; or
(4) A pharmacy technician program that meets the guidelines of the American Society of Health-System Pharmacists, is licensed by the District of Columbia Educational Licensure Commission, and has certified to the Board its intent to pursue accreditation upon becoming eligible to do so.
9902.2 To apply for a pharmacy technician registration an applicant shall:
(a) Submit a completed application to the Board on the required forms and include:
(1) The applicant’s social security number on the application. If the applicant does not have a social security number, the applicant shall:
(i) Submit with the application a sworn affidavit, under penalty of perjury, stating that he or she does not have a social security number; and
(ii) Submit proof acceptable to the Board that he or she is legally authorized to be in the United States, such as a Certificate of Citizenship or Naturalization, Resident Alien Card, a valid foreign passport with a visa; or a work permit card from the Department of Homeland Security (I-766 or I-688B).
(2) Two (2) recent passport-type photographs of the applicant’s face measuring two inches by two inches (2” x 2”), which clearly expose the area from the top of the forehead to the bottom of the chin; and
(3) One (1) clear photocopy of a U.S. government-issued photo ID, such as a driver’s license, as proof of identity.
(b) Submit proof acceptable to the Board that the applicant has successfully met the requirements set forth in § 9902.1, § 9905.1 or § 9912.1 of this chapter;
(c) Undergo a criminal background check; and
(d) Pay all required fees.
9903 Criteria for APPROVAL OF Pharmacy Technician Training Programs
9903.1 The provider of a pharmacy technician training program shall submit a completed application to the Board on the required forms and include payment of the application fee.
9903.2 To be approved by the Board, a pharmacy technician training program shall, at a minimum, provide instruction in 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) Sterile and non-sterile compounding;
(i) Requirements and professional standards for:
(1) Preparing;
(2) Labeling;
(3) Dispensing;
(4) Storing;
(5) Prepackaging;
(6) Distributing; and
(7) How medications are administered;
(j) Confidentiality;
(k) Drugs used to treat major chronic conditions;
(l) Federal and District laws and regulations governing controlled substances and the practice of pharmacy; and
(m) Knowledge of special dosing considerations for pediatric and geriatric populations.
9903.3 A pharmacy technician training program shall include a minimum of one hundred sixty (160) hours of practical experience.
9903.4 A pharmacy technician training program may not be longer than one (1) year.
9903.5 The Director of a pharmacy technician training program shall be qualified by education or experience to perform in this capacity.
9903.6 The Board shall have final approval of a pharmacy technician training program.
9903.7 The Board shall approve Pharmacy technician training programs offered by the U.S. Armed Forces.
9903.8 The Board may withdraw approval of a program if the Board finds that the program is in violation of this chapter.
9903.9 A pharmacy technician training program approval shall expire five (5) years from the date of issuance.
9903.10 To maintain continued approval the program shall submit the renewal application, renewal fee, and a self-evaluation report on a form provided by the Board at the time of renewal notification.
9903.11 Renewal of a program's approval is at the discretion of the Board, and the decision to renew shall be based on documentation of continued compliance with the criteria set forth in this chapter.
9903.12 A pharmacy technician training program shall report within thirty (30) days any substantive change in the program to include a change in:
(a) Program name;
(b) Program director;
(c) Instructors;
(d) Name of institution or business if applicable;
(e) Address;
(f) Program content;
(g) Length of program; or
(h) Location of records.
9903.13 A pharmacy technician training program shall maintain records of participants for five (5) years from date of completion or termination of program. The records shall be maintained either on-site or at another location where the records are readily retrievable upon request for inspection. A program shall provide a certificate of completion to participants who successfully complete the program and provide verification of completion of the program for a participant upon request by the Board.
9904 EXAMINATION REQUIREMENTS FOR PHARMACY TECHNICIAN
TRAINING PROGRAMS
9904.1 To be approved by the Board a training program examination shall:
(a) Test for competency of the content criteria set forth in § 9903.2 of this chapter;
(b) Include a minimum of ninety (90) multiple choice questions;
(c) Include sufficient additional questions so that the examination questions may be rotated twice a year;
(d) Require a passing score of seventy-five percent (75%) or higher; and
(e) Shall be certified as psychometrically valid.
9905 REGISTRATION BY RECIPROCITY
9905.1 An individual, holding an active pharmacy technician registration in another state, shall apply for registration by reciprocity as follows:
(a) Submit a completed application to the Board on the required forms and include:
(1) The applicant’s social security number on the application. If the applicant does not have a social security number, the applicant shall:
(i) Submit with the application a sworn affidavit, under penalty of perjury, stating that he or she does not have a social security number; and
(ii) Submit proof acceptable to the Board that he or she is legally authorized to be in the United States, such as a Certificate of Citizenship or Naturalization, Resident Alien Card, a valid foreign passport with a visa; or a work permit card from the Department of Homeland Security (I-766 or I-688B).
(2) Two (2) recent passport-type photographs of the applicant’s face measuring two inches by two inches (2” x 2”), which clearly expose the area from the top of the forehead to the bottom of the chin; and
(3) One (1) clear photocopy of a U.S. government-issued photo ID, such as a driver’s license, as proof of identity.
(b) Submit proof of current licensure, registration, or certification, in good standing, to practice as a pharmacy technician in another state;
(c) Obtain verification from each state in which the applicant holds or has ever held a pharmacy technician registration, that the registration is current and in good standing, or if the registration is no longer active, that it was in good standing immediately prior to its expiration. The registration verification form must be sent directly to the Board, by the verifying Board;
(d) Undergo a criminal background check; and
(e) Pay all required fees.
9906 REGISTRATION FOR PHARMACY TECHNICIAN TRAINEES
9906.1 A person shall register with the Board as a pharmacy technician trainee within thirty (30) days after beginning an employer-based pharmacy technician program recognized by the Board.
9906.2 Individuals enrolled in a non-employer-based pharmacy technician training program shall register with the Board as a pharmacy technician trainee prior to performing duties of a pharmacy technician trainee in a pharmacy.
9906.3 A pharmacy technician trainee registration shall expire one (1) year from the date of issuance and shall not be renewed.
9906.4 Every pharmacy that uses a person as a pharmacy technician trainee shall have documentation on site at the pharmacy and available for inspection showing that the person is currently enrolled in a Board approved pharmacy technician training program.
9906.5 A registered pharmacy technician trainee may provide the pharmacy technician functions permitted under § 9910 of this chapter, under the direct supervision of a licensed pharmacist, commensurate with the training and experience he or she has received.
9906.6 To be eligible to register as a pharmacy technician trainee a person shall:
(a) Be at least 17 years of age;
(b) Have a high school diploma or its equivalent; and
(c) Be enrolled in a Board-approved pharmacy technician training program or employed in a pharmacy as a pharmacy technician trainee.
9906.7 To apply for a registration as a pharmacy technician trainee a person shall:
(a) Submit a completed application to the Board on the required forms and include:
(1) The applicant’s social security number on the application. If the applicant does not have a social security number, the applicant shall:
(i) Submit with the application a sworn affidavit, under penalty of perjury, stating that he or she does not have a social security number; and
(ii) Submit proof acceptable to the Board that he or she is legally authorized to be in the United States, such as a Certificate of Citizenship or Naturalization, Resident Alien Card, a valid foreign passport with a visa; or a work permit card from the Department of Homeland Security (I-766 or I-688B).
(2) Two (2) recent passport-type photographs of the applicant’s face measuring two inches by two inches (2” x 2”), which clearly expose the area from the top of the forehead to the bottom of the chin; and
(3) One (1) clear photocopy of a U.S. government-issued photo ID, such as a driver’s license, as proof of identity.
(b) Submit proof acceptable to the Board that the applicant has successfully met the requirements set forth in § 9906.5 of this chapter;
(c) Undergo a criminal background check; and
(d) Pay all required fees.
9907 CONTINUING EDUCATION REQUIREMENTS
9907.1 Except as provided in § 9907.2, this section shall apply to all applicants for the renewal, reactivation, or reinstatement of a pharmacy technician registration.
9907.2 This section shall not apply to applicants for the first renewal of a pharmacy technician registration.
9907.3 A continuing education credit shall be valid only if it is part of a program approved by the Board in accordance with § 9908 of this chapter.
9907.4 An applicant for renewal of a pharmacy technician registration shall:
(a) Have completed a minimum of twenty (20) contact hours of continuing education credit in pharmacy-related subject matter, which shall include at least two (2) contact hours of continuing education credit in pharmacy law, and two (2) contact hours in medication safety, during the two (2) year period preceding the date the registration expires;
(b) Attest to completion of the required continuing education credits on the renewal application form; and
(c) Be subject to a random audit.
9907.5 For the purposes of this section, pharmacy-related subject matter shall include, but not be limited to, the following topics:
(a) Medication distribution;
(b) Inventory control systems;
(c) Pharmaceutical mathematics;
(d) Pharmaceutical sciences;
(e) Pharmacy law;
(f) Pharmacology/drug therapy;
(g) Pharmacy quality assurance; and
(h) Roles and duties of pharmacy technicians.
9907.6 To qualify for reinstatement or reactivation of a pharmacy technician registration, an applicant shall have completed a minimum of twenty (20) contact hours of continuing education credit in pharmacy-related subject matter in the year immediately preceding the date of the application, which shall include at least two (2) contact hours of continuing education credit in pharmacy law and two (2) contact hours in medication safety.
9907.7 Except as provided in § 9907.8, an applicant under this section shall prove completion of required continuing education credits by submitting the following information with respect to each program:
(a) The name and address of the sponsor of the program;
(b) The name of the program, its location, a description of the subject matter covered, and the names of the instructors;
(c) The dates on which the applicant attended the program;
(d) The hours of credit claimed; and
(e) Verification by the sponsor of completion, by signature or stamp.
9907.8 Applicants for renewal of a registration shall only be required to prove completion of the required continuing education credits by submitting proof pursuant to § 9907.7 if requested to do so as part of the random audit, or if otherwise requested to do so by the Board.
9907.9 An applicant for renewal of a registration who fails to renew the registration by the date the registration expires may renew the registration for up to sixty (60) days after the date of expiration by completing the application, submitting the required supporting documents, and paying the required late fee. Upon renewal, the applicant shall be deemed to have possessed a valid registration during the period between the expiration of the registration and the renewal thereof.
9907.10 If an applicant for renewal of a registration fails to renew the registration and pay the late fee within sixty (60) days after the expiration of applicant's registration, the registration shall be considered to have lapsed on the date of expiration. The applicant shall thereafter be required to apply for reinstatement of an expired registration and meet all requirements and fees for reinstatement.
9907.11 The Board may, in its discretion, grant an extension of the sixty (60) day period, up to a maximum of one (1) year, to renew after expiration if the applicant's failure to renew was for good cause. As used in this section, "good cause" includes the following:
(a) Serious and protracted illness of the applicant; and
(b) The death or serious and protracted illness of a member of the applicant's immediate family.
9907.12 An extension granted under this section shall not exempt the pharmacy technician from complying with the continuing education requirements for any other renewal period.
9908 APPROVED CONTINUING EDUCATION PROGRAMS AND ACTIVITIES
9908.1 The Board may, in its discretion, approve continuing education programs that contribute to the growth of an applicant in professional competence as a pharmacy technician and meet the other requirements of this section.
9908.2 To qualify for approval by the Board, a continuing education program shall be a structured educational activity that provides instruction in the subject matter set forth in § 9907.5, and shall include the following:
(a) Programs offered by an ACPE provider;
(b) Programs approved by other Boards of Pharmacy; or
(c) Programs offered by an institution of higher learning recognized by an accrediting body approved by the Secretary of the United States Department of Education.
9908.3 The Board may approve additional continuing education programs offered by other providers if the programs meet the following requirements:
(a) Prior to a program offering, the provider shall complete an application form and include all required materials for review;
(b) The application shall be submitted by the provider to the Board for review no less than ninety (90) days prior to the presentation;
(c) The content of the program shall be current in its subject matter; and
(d) The content of the program shall be developed and taught by individuals with demonstrated qualifications in the topic.
9908.4 Continuing education programs approved by the Board pursuant to § 9908.3 shall be valid for a two (2) year period and may be audited by the Board.
9908.5 For programs approved by the Board pursuant to § 9908.3:
(a) The provider shall inform the Board of any changes in information previously provided about the program or provider prior to offering the program again. Failure to notify the Board may result in the Board withdrawing its approval;
(b) If a provider wants to give a live program more than once, all program dates must either be submitted on the original application or provided to the Board in subsequent correspondence at least five (5) days prior to giving the program. Failure to submit substantive changes to an approved program to the Board may result in the Board withdrawing approval of the program; and
(c) The provider of an approved continuing education program shall maintain all records on that program, its participants, and hours awarded for a period of four (4) years and shall make those records available to the board upon request.
9908.6 The Board may issue a list of approved continuing education programs.
9908.7 An applicant shall have the burden of verifying whether a program is approved by the Board pursuant to this section prior to attending the program.
9909 CONTINUING EDUCATION CREDITS
9909.1 A contact hour shall consist of at least sixty (60) minutes of instruction in an approved continuing education program and shall equal one-tenth (0.1) of a continuing education credit (“CEU”).
9909.2 A maximum of ten (10) contact hours of the required twenty (20) contact hours may be earned by completing a relevant college course with a grade of “C” or better.
9909.3 For approved college courses, each semester hour of credit constitutes ten (10) contact hours of continuing education credit, and each quarter hour constitutes five (5) contact hours of continuing education credit.
9909.4 A continuing education credit shall only be valid if it is earned in a topic listed under § 9907.5.
9910 SCOPE OF PRACTICE
9910.1 A registered pharmacy technician may perform pharmacy technician functions only in accordance with this chapter.
9910.2 A registered pharmacy technician may provide pharmacy technician functions under the direct supervision of a licensed pharmacist that shall include but are not limited to the following:
(a) Entering prescription and drug history information into a data system or other record keeping system;
(b) Compounding and reconstituting drugs for dispensing;
(c) Calling a physician for refill authorization for non-controlled substances in which no changes are made to the order;
(d) Preparing prescription labels or patient information;
(e) Removing the drug to be dispensed from inventory;
(f) Counting or measuring the drug to be dispensed;
(g) Packaging and labeling the drug to be dispensed and the repackaging thereof;
(h) Stocking or loading automated dispensing devices or other devices used in the dispensing process;
(i) Placing, receiving, unpacking, and storing drug orders;
(j) Checking all prescription and non-prescription stock for outdates and processing of outdated returns;
(k) Assisting the pharmacist in preparing and reconstituting sterile products and other medications;
(l) Retrieving prescription files, patient files, profiles, and other records pertaining to the practice of pharmacy; and
(m) Notifying the patient or the patient's agent of the opportunity to receive an oral consultation from the pharmacist.
9910.3 Notwithstanding § 9910.2, a registered pharmacy technician shall not provide the following services:
(a) Drug regimen review;
(b) Clinical conflict resolution;
(c) Prescriber contact, except for receiving authorization of prescription refills;
(d) Therapy modification;
(e) Patient counseling as described in 22-B DCMR § 1919;
(f) Dispensing process validation;
(g) Vaccination or immunization administration;
(h) Receiving a new prescription drug order over the telephone;
(i) Any activity required by law or regulation to be performed only by a pharmacist; or
(j) Any activity for which professional pharmaceutical judgment is required.
9911 OTHER PHARMACY RELATED SERVICES
9911.1 Unless otherwise authorized by the Board, an individual who works at a pharmacy and is not licensed or registered by the Board as a pharmacist or pharmacy intern or authorized to perform the services of a pharmacy technician under this chapter, may perform only ancillary pharmacy services, such as:
(a) Cashiering;
(b) Bookkeeping;
(c) Pricing;
(d) Stocking;
(e) Delivering;
(f) Answering nonprofessional questions and telephone inquiries;
(g) Documenting third-party reimbursement; and
(h) Notifying the patient or the patient's agent of the opportunity to receive an oral consultation from the pharmacist.
9911.2 An individual who is not licensed or registered by the Board as a pharmacist or pharmacy intern or authorized to perform the services of a pharmacy technician under this chapter shall not perform the tasks of a:
(a) Pharmacist;
(b) Pharmacy intern;
(c) Pharmacy technician; or
(d) Pharmacy technician trainee
9912 GRANDFATHERING
9912.1 For a period of one year after the effective date of these regulations, an applicant who does not meet the requirements for registration set forth in § 9902.1 or § 9905.1 of this chapter shall be eligible for registration as a pharmacy technician if:
(a) The applicant is at least seventeen (17) years of age; and
(b) The applicant submits proof, acceptable to the Board, that he or she has worked as a pharmacy technician for at least twenty-four (24) consecutive months immediately prior to the effective date of the Act; and
(c) A licensed pharmacist or pharmacists who have supervised the applicant for at least six (6) months immediately prior to the date of the application attests in writing that the applicant has competently performed the functions of a pharmacy technician; or
(d) Demonstrates to the satisfaction of the Board that the applicant has been performing the function of pharmacy technician on a full-time or substantially full-time basis continually for at least twenty-four (24) months immediately preceding the effective date of the Act and is qualified to do so on the basis of pertinent education, training, experience, and demonstrated current experience.
9912.2 For a period of one year after the effective date of these regulations an applicant who is not eligible for registration under § 9902.1, § 9905.1 or § 9912.1 of this chapter may engage in practice as a pharmacy technician if the applicant:
(a) Has received training to enable him or her to competently and safely perform the tasks assigned; and
(b) Engages in such practice under the direct supervision of a D.C. licensed pharmacist.
9912.3 A person who is engaging in practice as a pharmacy technician pursuant to § 9912.2 of this chapter shall cease practicing as a pharmacy technician after the one year period expires.
9999 DEFINITIONS
As used in this chapter, the following terms shall have the meaning as ascribed:
Act – Pharmacy Technician Amendment Act of 2012, effective May 1, 2013, (D.C. Law 19-0303; D.C. Official Code §§ 3-1207.51 et seq.).
Board – the Board of Pharmacy
Direct supervision – with respect to the supervision of the pharmacy technician or pharmacy technician trainee, that a licensed pharmacist is:
(a) Physically present at the same pharmacy as the pharmacy technician or pharmacy technician trainee and in the general vicinity of the pharmacy technician or pharmacy technician trainee;
(b) Readily available to answer questions of the pharmacy technician or pharmacy technician trainee;
(c) Making appropriate in-process and end-process verifications of the activities of the pharmacy technician or pharmacy technician trainee; and
(d) Fully responsible for the practice of the pharmacy technician or pharmacy technician trainee.
Pharmacy technician functions - technical pharmacy-related services, that do not require professional judgment regarding the preparation and distribution of drugs, performed under the direct supervision of a licensed pharmacist.
Pharmacy technician trainee – a person enrolled in a Board-approved training program who may perform the duties of a registered pharmacy technician under the direct supervision of a pharmacist in a licensed pharmacy in the District.
Registered pharmacy technician – a person who is registered with the Board as a pharmacy technician.
