Rule 20:51:29 REGISTERED PHARMACY TECHNICIANS
Rule 20:51:29:00 Definitions.
20:51:29:00. Definitions.
(1) "Board" or
"board of pharmacy," as defined in SDCL 36-11-2(2);
(2) "Pharmacist,"
as defined in SDCL 36-11-2(18);
(3) "Pharmacist
intern," as defined in § 20:51:02:01;
(4) "Registered
pharmacy technician," as defined in SDCL 36-11-2(22A);
(5) "Pharmacy
technician-in-training," an individual who is registered with the board to
receive on-the-job training in a licensed pharmacy for preparation for
registration as a pharmacy technician.
Source:
31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17,
2012.
General
Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:01 Purpose of registration.
20:51:29:01. Purpose
of registration. A registration program for pharmacy technicians and
pharmacy technicians-in-training is established for the primary purpose of
assuring the competency of registered pharmacy technicians and for purposes of
identification, tracking, and disciplinary actions.
Source:
31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17,
2012.
General
Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:02 Registration required.
20:51:29:02. Registration
required. Any person employed in South Dakota as a pharmacy technician or
pharmacy technician-in-training shall obtain and maintain during such
employment a current registration as a pharmacy technician or pharmacy
technician-in-training pursuant to this chapter. Any person accepting
employment as a pharmacy technician or pharmacy technician-in-training in South
Dakota who fails to register as a pharmacy technician or pharmacy
technician-in-training as provided by rule may be subject to disciplinary
sanction as provided by rule § 20:51:29:27.
Source:
31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17,
2012.
General
Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:03 Original application.
20:51:29:03. Original
application. Any person initially applying for a certificate of
registration as a pharmacy technician or pharmacy technician-in-training shall
submit an application to the board within 30 days of accepting employment in a
South Dakota pharmacy as a pharmacy technician or pharmacy
technician-in-training.
Effective July 1, 2014, the board
shall not issue an initial pharmacy technician registration or pharmacy
technician-in-training 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 was
registered by the board prior to July 1, 2011, may renew the individual's
registration provided that all other requirements for renewal are met and
provided that the individual maintains a pharmacy technician registration or
national certification on an uninterrupted basis. Any individual whose
registration or national certification lapses for a period of one year must
meet the registration requirements in effect at the time the individual applies
for reinstatement of registration.
Source:
31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17,
2012.
General
Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:04 College or vocational based training program.
20:51:29:04. College
or vocational based training program. Any person who is enrolled in a
college or vocational-based technician training program is required to obtain a
pharmacy technician-in-training registration prior to beginning on-site
practical experience. The length of technician-in-training program may not
exceed a period of more than two years.
Source:
31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17,
2012.
General
Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:05 Exemptions from registration.
20:51:29:05. Exemptions from registration. A registered
pharmacy intern whose South Dakota registration is in good standing and who
assists in the technician function of the practice of pharmacy is not required
to register as a pharmacy technician.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:06 Certification of pharmacy technicians.
20:51:29:06. Certification
of pharmacy technicians. The national certification of pharmacy technicians
is required. Effective July 1, 2014, the board shall not renew the registration
of a pharmacy technician who was initially registered after July 1, 2011,
unless the pharmacy technician is nationally certified and has passed a
board-approved pharmacy technician certification examination that is accredited
by the National Commission for Certifying Agencies (NCCA).
Pharmacy technician national
certification does not supplant the need for a licensed pharmacist to exercise
control over the performance of a delegated function nor does national
certification exempt the pharmacy technician from registration pursuant to this
chapter.
Source:
31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17,
2012.
General
Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:07 Registration application form.
20:51:29:07. Registration application form. The
application form for registration as a pharmacy technician shall include the
following:
(1) Information sufficient
to identify the applicant including name, address, phone number, date of birth,
gender, and social security number;
(2) Work experience; and
(3) Current
and past places of employment.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:08 Declaration of current impairment or limitations.
20:51:29:08. Declaration of current impairment or
limitations. The applicant shall declare any current use of drugs, alcohol,
or other chemical substances that in any way impairs or limits the applicant's
ability to perform the duties of a pharmacy technician with reasonable skill
and safety.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:09 Felony or misdemeanor crimes.
20:51:29:09. Felony or misdemeanor crimes. The applicant
shall declare any history of being charged, convicted, found guilty of or
entering a plea of guilty or no contest to a felony or
misdemeanor crime other than minor traffic violations with fines under $100.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:10 Sworn signature.
20:51:29:10. Sworn signature. The applicant shall sign
the application under penalty of perjury and shall submit it to the board.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:11 Registration renewal.
20:51:29:11. Registration renewal.
The registration of a pharmacy technician expires on October 31 each year
following initial registration.
Effective July 1, 2014, the board
shall not renew the registration of a pharmacy technician who was initially registered
after July 1, 2011, 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 480 hours
in 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 pharmacy technician who completes the
training program with 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.
Source:
31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17,
2012.
General
Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:12 Registration fee.
20:51:29:12. Registration fee. The fee for initial
registration is $25. The renewal fee for the registration is $25. Fees shall be paid at the time the new application or the renewal
application is submitted. Fee payment shall be in the form of a personal check,
certified or cashier check, or money order payable to the Board of Pharmacy.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:13 Timeliness of initial application or renewal application.
20:51:29:13. Timeliness of initial application or renewal
application. An application for initial or renewal application may be
denied if not received within the applicable period specified in
§ 20:51:29:03 for new applicants or by the expiration date of the renewal
registration. Any registration not renewed before its expiration date is
delinquent. An individual who continues employment as a pharmacy technician
without a current registration may be subject to disciplinary sanctions as
provided in § 20:51:29:27.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:14 Registration certification.
20:51:29:14. Registration certification. The pharmacy
technician shall maintain the original certificate of registration as a
pharmacy technician issued by the board. The pharmacist-in-charge
(§ 20:51:06:02.01) of each pharmacy utilizing a pharmacy technician is
responsible for verifying that any technician working in the pharmacy is
registered and compliant with all rules of this chapter. Any violation by the
technician may be grounds for disciplinary action against the
pharmacist-in-charge.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:15 Notification to the board.
20:51:29:15. Notification to the board. Within ten days
of any change of the technician's name, address, or pharmacy employment status,
a pharmacy technician shall report that change to the board.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:16 Training and utilization of pharmacy technicians.
20:51:29:16. Training
and utilization of pharmacy technicians. Notwithstanding the fact that a
pharmacy technician has completed a training program as specified in
§ 20:51:29:11, 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 pharmacy technicians working at that pharmacy. Any pharmacy
utilizing a pharmacy technician shall develop, implement, and periodically
review written policies and procedures for training and utilizing pharmacy
technicians appropriate to the practice of pharmacy at that pharmacy. Each
pharmacy shall specify in its policies the frequency of review. Each pharmacy
shall document and maintain each technician's training for the duration of employment.
The pharmacy shall make its policies and procedures and documentation of
technician training available for inspection by the board.
Source:
31 SDR 35, effective September 19, 2004; 38 SDR 121, effective January 17,
2012.
General
Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:17 Identification of pharmacy technicians.
20:51:29:17. Identification of pharmacy technicians. A
pharmacy technician shall wear a visible identification badge while on duty
that clearly identifies the person as a pharmacy technician and includes the
technician's first name.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:18 Misrepresentation prohibited.
20:51:29:18. Misrepresentation prohibited. A pharmacy
technician may not represent himself or herself in any manner as a pharmacist.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:19 Ratio.
20:51:29:19. Ratio.
The ratio of pharmacy technicians to pharmacists that may be on duty in a
pharmacy at a given time is two technicians for every pharmacist. A pharmacy
intern does not count in this ratio (§ 20:51:02:11.01).
Source:
31 SDR 35, effective September 19, 2004.
General
Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:19.01 Exception to ratio for mail service pharmacy.
20:51:29:19.01. Exception
to ratio for mail service pharmacy. The maximum ratio of pharmacy
technicians to pharmacists that may be on duty in a mail service pharmacy is
four technicians for every pharmacist on duty. However, all of the following
requirements must be met:
(1) Medication is dispensed
pursuant to a legal prescription;
(2) Bar code technology is
used in all aspects of the prescription filling process;
(3) Pharmacy robotics with
RFID/bar coding is used within the prescription filling process;
(4) The technology includes
tablet/product imaging;
(5) High resolution
scanners are used at order entry;
(6) A role-based access
software automation system, which places stop points within the prescription
filling process, is used which requires pharmacist intervention before allowing
the prescription to move to the next step in the prescription dispensing
process;
(7) Enhanced pharmacy
software that screens and detects drug allergies, identifies drug interactions,
and checks age appropriate dosage ranges is used;
(8) A pharmacist reviews
clinically significant computer warnings of drug interactions, therapy
duplications, and contraindications;
(9) Electronic surveillance
technology is used to control access and to provide continuous monitoring of
all areas where drugs are stored or dispensed, or both;
(10) All non-pharmacist
personnel who input patient drug information into a computer or whose duties
include receiving, packaging, shipping of drugs, or who have access to any areas
where drugs are dispensed are registered as pharmacy technicians and meet the
requirements in chapter 20:51:29;
(11) Technicians above a
2:1 ratio must have completed a board-approved pharmacy technician education
program or have passed a pharmacy technician certification examination that is
accredited by the National Commission for Certifying Agencies (NCCA);
(12) A patient has access
to a pharmacist 24 hours a day, 7 days a week on a dedicated pharmacist staff
line;
(13) Drug information, both
computerized and hard copy, is readily available to pharmacists;
(14) A quality assurance
program that identifies and evaluates dispensing errors, accompanied by a
continuous quality improvement program that assures very high dispensing
accuracy rates in place;
(15) There are written
policies and procedures for all pharmacy functions -- clerical, supportive,
technical, and clinical;
(16) There are written
policies and procedures for training personnel, including on-going training
programs for all personnel and documentation of that training for each
employee;
(17) There is a strict
monitoring program designed to prevent diversion of controlled substances. This
includes perpetual inventory of all schedule II controlled drugs as well as
selected high-risk schedule III, IV, and V drugs. Routine audits are conducted
to review purchases versus dispensing of controlled drugs to deter or detect
diversion.
A mail service pharmacy operating
pursuant to this section may not actively solicit prescriptions from individual
South Dakota residents.
For the purpose of this section, a
mail-service pharmacy is a pharmacy that does not deal directly with patients
face-to-face and conducts 100 percent of its business by mail, e-mail, or
telephone.
Source:
33 SDR 73, effective November 6, 2006; 36 SDR 21, effective August 17, 2009.
General
Authority: SDCL 36-11-11(1)(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:19.02 Exception to ratio for retail, hospital, and long-term care pharmacy.
20:51:29:19.02. Exception
to ratio for retail, hospital, and long-term care pharmacy. The maximum
ratio of pharmacy technicians to pharmacists that may be on duty in a retail,
hospital, and long-term care pharmacy is three technicians for every pharmacist
on duty. However, if applicable to the practice and services provided all of
the following requirements must be met:
(1) Medication is dispensed
pursuant to a legal prescription;
(2) The technology includes
tablet or product imaging and or bar code scanning, or both, to insure accuracy
in the prescription filling process;
(3) A role-based access
software automation system that places stop points within the prescription
filling process is used, which requires a pharmacist's intervention before allowing
the prescription to move to the next step in the prescription dispensing
process;
(4) Pharmacy software that
screens and detects drug allergies, identifies drug interactions, and checks
age appropriate dosage ranges is used;
(5) A pharmacist reviews
clinically significant computer warnings of drug interactions, therapy
duplications, and contraindications;
(6) Electronic surveillance
technology is used to control access or to provide continuous monitoring of all
areas where drugs are stored or dispensed;
(7) All non-pharmacist
personnel who input patient drug information into a computer or whose duties
include receiving, packaging, shipping of drugs, or who have access to any
areas where drugs are dispensed are registered as pharmacy technicians and meet
the requirements in chapter 20:51:29;
(8) Technicians above a 2:1
ratio must have completed a board-approved technician education program and
have passed a board-approved pharmacy technician certification examination that
is accredited by the National Commission for Certifying Agencies (NCCA);
(9) In retail pharmacies,
patients have access to a pharmacist during normal business hours on a
dedicated pharmacy staff line. In hospital and long-term care pharmacies,
nursing personnel in facilities served by the pharmacy have telephone access to
a pharmacist 24 hours a day, 7 days a week;
(10) Drug information, both
electronic and hard copy, is readily available to pharmacists;
(11) A quality assurance
program that identifies and evaluates dispensing errors, accompanied by a
continuous quality improvement program that assures very high dispensing
accuracy rates in place;
(12) There are written
policies and procedures for all pharmacy functions -- clerical, supportive,
technical, and clinical;
(13) There are written
policies and procedures for training personnel, including on-going training
programs for all personnel and documentation of that training for each
employee;
(14) There is a strict
monitoring program designed to prevent diversion of controlled substances. This
includes perpetual inventory of all schedule II controlled drugs as well as
selected high-risk schedule III, IV, and V drugs. Routine audits are conducted
to review purchases versus dispensing of controlled drugs to deter and detect
diversion.
Source:
36 SDR 21, effective August 17, 2009.
General
Authority: SDCL 36-11-11(1)(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:20 Delegation and supervision of technical functions.
20:51:29:20. Delegation and supervision of technical
functions. A pharmacist may delegate technical dispensing functions to a
pharmacy technician, but only if the pharmacist is on site supervising the
delegated functions performed. The pharmacist shall provide and document the
final verification for the accuracy, validity, completeness, and
appropriateness of the patient's prescription or medication order prior to the
delivery of the medication to the patient or the patient's representative.
The physical presence requirement of
the pharmacist does not apply when utilizing an automated dispensing device
approved by the board. After proper checking and verification with the
physician orders by the pharmacist, the technician may replace medications to
the automated dispensing device that have been checked
by the pharmacist. The pharmacist is not required to accompany the technician
when placing medications into the automated dispensing device. The automated
dispensing device must be capable of printing out a record of medications
filled by the technician. The record shall be checked and
verified by the pharmacist daily.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:21 Technical functions.
20:51:29:21. Technical functions. At the discretion of
the supervising pharmacist, technical functions which may be
delegated to a pharmacy technician include the following:
(1) Performing packaging,
manipulative, or repetitive tasks relating to the processing of a prescription
or medication order in a licensed pharmacy;
(2) Accepting prescription
refill authorization communicated to a pharmacy by a prescriber, or by the
prescriber's agent;
(3) Contacting prescribers
to obtain prescription refill authorization;
(4) Collecting pertinent
patient information;
(5) Inspecting drug
supplies provided and controlled by a South Dakota licensed pharmacy, including
drug supplies maintained in an automated mechanical dispensing device,
emergency medical room, ambulance vehicle, long-term care facility, a hospital
nursing unit, or a hospice facility;
(6) Assisting the
pharmacist with the preparation of medications for administration to the
patient topically, by injection, or other approved methods.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:22 Tasks a pharmacy technician may not perform.
20:51:29:22. Tasks a pharmacy technician may not perform.
A pharmacy technician may not:
(1) Provide the final
verification for the accuracy, validity, completeness, or appropriateness of a
filled prescription or medication order;
(2) Conduct prospective
drug use review or evaluate a patient's medication record for purposes
identified in § 20:51:25:02;
(3) Provide final
verification of automated dispensing medication fill records for accuracy and
completeness;
(4) Make decisions that
require a pharmacist's professional judgment such as interpreting new orders,
applying information, or making product selection for drugs that are
substitutable;
(5) Accept new oral
prescription medication orders communicated to the pharmacy by a prescriber or
the prescriber's agent; or
(6) Open, keep open, or
provide pharmaceutical services from a pharmacy without a pharmacist being
present as provided in §§ 20:51:06:11, 20:51:15:02, and 20:51:15:04.
A violation of this section
constitutes illegal conduct or practice and may be grounds for disciplinary
action as provided in § 20:51:29:27.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:23 Misrepresentative deeds.
20:51:29:23. Misrepresentative deeds. A pharmacy
technician may not make any statement tending to deceive, misrepresent, or
mislead anyone, or be a party to or an accessory to any fraudulent or deceitful
practice or transaction in a pharmacy or in the operation or conduct of a
pharmacy.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:24 Confidentiality.
20:51:29:24. Confidentiality.In the
absence of express written consent from the patient or written order or
direction of a court, except where the best interests of the patient require, a
pharmacy technician may not divulge or reveal to any person other than the
patient or the patient's authorized representative, the prescriber, or other
licensed practitioner then caring for the patient, a licensed pharmacist or a
person duly authorized by law to receive such information, any of the
following:
(1) The contents of any
prescription drug order or medication or the therapeutic effect thereof or the
nature of professional pharmaceutical services rendered to a patient;
(2) The nature, extent, or
degree of illness suffered by any patient; or
(3) Any medical information
furnished by the prescriber.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:25 Illegal/unethical behavior.
20:51:29:25. Illegal/unethical behavior. A pharmacy
technician may not exhibit illegal/unethical behavior in connection with the
technician's pharmacy employment. Illegal/unethical behavior includes the
following acts: verbal or physical abuse, coercion, intimidation, harassment,
sexual advances, threats, degradation of character, profanity, indecent or
obscene conduct, and theft. A violation of this section may be grounds for
disciplinary action as provided in § 20:51:29:27.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:26 Denial of registration.
20:51:29:26. Denial of registration. The board may deny
an application for registration as a pharmacy technician for any violation of
the laws of this state, another state, or the United States relating to
prescription drugs, controlled substances, or nonprescription drugs (or for any
violation of this chapter).
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
Rule 20:51:29:27 Sanctions.
20:51:29:27. Sanctions.
The board may impose the following disciplinary sanctions for violations of
this chapter:
(1) Revoke a pharmacy
technician registration;
(2) Suspend
a pharmacy technician registration until further order of the board or for a
specified period;
(3) Not
renew of a pharmacy technician registration;
(4) Prohibit permanently,
until further order of the board, or for a specified period, the engaging in
specified procedures, methods, or acts;
(5) Impose a probationary
period;
(6) Order a physical or
mental examination;
(7) Issue a citation and
warning.
Source:
31 SDR 35, effective September 19, 2004.
General Authority: SDCL 36-11-11(1), 36-11-11(14).
Law
Implemented: SDCL 36-11-11(14).
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