22 Tex. Admin. Code § 291.32 - Personnel
(a) Pharmacist-in-charge.
(1) General.
(A) Each Class A pharmacy shall have one
pharmacist-in-charge who is employed on a full-time basis and who may be the
pharmacist-in-charge for only one such pharmacy; provided, however, such
pharmacist-in-charge may be the pharmacist-in-charge of:
(i) more than one Class A pharmacy, if the
additional Class A pharmacies are not open to provide pharmacy services
simultaneously; or
(ii) during an
emergency, up to two Class A pharmacies open simultaneously if the
pharmacist-in-charge works at least 10 hours per week in each pharmacy for no
more than a period of 30 consecutive days.
(B) The pharmacist-in-charge shall comply
with the provisions of §
291.17 of this title (relating to
Inventory Requirements).
(C) The
pharmacist-in-charge of a Class A pharmacy may not serve as the
pharmacist-in-charge of a Class B pharmacy or a Class C pharmacy with 101 beds
or more.
(2)
Responsibilities. The pharmacist-in-charge shall have responsibility for the
practice of pharmacy at the pharmacy for which he or she is the
pharmacist-in-charge. The pharmacist-in-charge may advise the owner on
administrative or operational concerns. The pharmacist-in-charge shall have
responsibility for, at a minimum, the following:
(A) educating and training of pharmacy
technicians and pharmacy technician trainees;
(B) supervising a system to assure
appropriate procurement of prescription drugs and devices and other products
dispensed from the Class A pharmacy;
(C) disposing of and distributing drugs from
the Class A pharmacy;
(D) storing
all materials, including drugs, chemicals, and biologicals;
(E) maintaining records of all transactions
of the Class A pharmacy necessary to maintain accurate control over and
accountability for all pharmaceutical materials required by applicable state
and federal laws and sections;
(F)
supervising a system to assure maintenance of effective controls against the
theft or diversion of prescription drugs, and records for such drugs;
(G) adhering to policies and procedures
regarding the maintenance of records in a data processing system such that the
data processing system is in compliance with Class A pharmacy
requirements;
(H) legally operating
the pharmacy, including meeting all inspection and other requirements of all
state and federal laws or sections governing the practice of pharmacy;
and
(I) if the pharmacy uses an
automated pharmacy dispensing system, shall be responsible for the following:
(i) consulting with the owner concerning and
adherence to the policies and procedures for system operation, safety,
security, accuracy and access, patient confidentiality, prevention of
unauthorized access, and malfunction;
(ii) inspecting medications in the automated
pharmacy dispensing system, at least monthly, for expiration date, misbranding,
physical integrity, security, and accountability;
(iii) assigning, discontinuing, or changing
personnel access to the automated pharmacy dispensing system;
(iv) ensuring that pharmacy technicians,
pharmacy technician trainees, and licensed healthcare professionals performing
any services in connection with an automated pharmacy dispensing system have
been properly trained on the use of the system and can demonstrate
comprehensive knowledge of the written policies and procedures for operation of
the system; and
(v) ensuring that
the automated pharmacy dispensing system is stocked accurately and an
accountability record is maintained in accordance with the written policies and
procedures of operation.
(b) Owner. The owner of a Class A pharmacy
shall have responsibility for all administrative and operational functions of
the pharmacy. The pharmacist-in-charge may advise the owner on administrative
and operational concerns. The owner shall have responsibility for, at a
minimum, the following, and if the owner is not a Texas licensed pharmacist,
the owner shall consult with the pharmacist-in-charge or another Texas licensed
pharmacist:
(1) establishing policies for
procurement of prescription drugs and devices and other products dispensed from
the Class A pharmacy;
(2)
establishing policies and procedures for the security of the prescription
department including the maintenance of effective controls against the theft or
diversion of prescription drugs;
(3) if the pharmacy uses an automated
pharmacy dispensing system, reviewing and approving all policies and procedures
for system operation, safety, security, accuracy and access, patient
confidentiality, prevention of unauthorized access, and malfunction;
(4) providing the pharmacy with the necessary
equipment and resources commensurate with its level and type of practice;
and
(5) establishing policies and
procedures regarding maintenance, storage, and retrieval of records in a data
processing system such that the system is in compliance with state and federal
requirements.
(c)
Pharmacists.
(1) General.
(A) The pharmacist-in-charge shall be
assisted by a sufficient number of additional licensed pharmacists as may be
required to operate the Class A pharmacy competently, safely, and adequately to
meet the needs of the patients of the pharmacy.
(B) All pharmacists shall assist the
pharmacist-in-charge in meeting his or her responsibilities in ordering,
dispensing, and accounting for prescription drugs.
(C) Pharmacists are solely responsible for
the direct supervision of pharmacy technicians and pharmacy technician trainees
and for designating and delegating duties, other than those listed in paragraph
(2) of this subsection, to pharmacy technicians and pharmacy technician
trainees. Each pharmacist shall be responsible for any delegated act performed
by pharmacy technicians and pharmacy technician trainees under his or her
supervision.
(D) Pharmacists shall
directly supervise pharmacy technicians and pharmacy technician trainees who
are entering prescription data into the pharmacy's data processing system by
one of the following methods.
(i) Physically
present supervision. A pharmacist shall be physically present to directly
supervise a pharmacy technician or pharmacy technician trainee who is entering
prescription data into the data processing system. Each prescription entered
into the data processing system shall be verified at the time of data entry. If
the pharmacist is not physically present due to a temporary absence as
specified in §
291.33(b)(3) of
this title (relating to Operational Standards), on return the pharmacist must:
(I) conduct a drug regimen review for the
prescriptions data entered during this time period as specified in §
291.33(c)(2) of
this title; and
(II) verify that
prescription data entered during this time period was entered
accurately.
(ii)
Electronic supervision. A pharmacist may electronically supervise a pharmacy
technician or pharmacy technician trainee who is entering prescription data
into the data processing system provided the pharmacist:
(I) has the ability to immediately
communicate directly with the technician/trainee;
(II) has immediate access to any original
document containing prescription information or other information related to
the dispensing of the prescription. Such access may be through imaging
technology provided the pharmacist has the ability to review the original,
hardcopy documents if needed for clarification; and
(III) verifies the accuracy of the data
entered information prior to the release of the information to the system for
storage and/or generation of the prescription label.
(iii) Electronic verification of data entry
by pharmacy technicians or pharmacy technician trainees. A pharmacist may
electronically verify the data entry of prescription information into a data
processing system provided:
(I) the pharmacist
has the ability to immediately communicate directly with the
technician/trainee;
(II) the
pharmacist electronically conducting the verification is either a:
(-a-) Texas licensed pharmacist; or
(-b-) pharmacist employed by a Class E
pharmacy that:
(-1-) has the same owner as the
Class A pharmacy where the pharmacy technicians/trainees are located;
or
(-2-) has entered into a written
contract or agreement with the Class A pharmacy which outlines the services to
be provided and the responsibilities and accountabilities of each pharmacy in
compliance with federal and state laws and regulations;
(III) the pharmacy establishes
controls to protect the privacy and security of confidential records;
and
(IV) the pharmacy keeps
permanent records of prescriptions electronically verified for a period of two
years.
(E) All
pharmacists, while on duty, shall be responsible for the legal operation of the
pharmacy and for complying with all state and federal laws or rules governing
the practice of pharmacy.
(F) A
dispensing pharmacist shall be responsible for and ensure that the drug is
dispensed and delivered safely and accurately as prescribed, unless the
pharmacy's data processing system can record the identity of each pharmacist
involved in a specific portion of the dispensing processing. If the system can
track the identity of each pharmacist involved in the dispensing process, each
pharmacist involved in the dispensing process shall be responsible for and
ensure that the portion of the process the pharmacist is performing results in
the safe and accurate dispensing and delivery of the drug as prescribed. The
dispensing process shall include, but not be limited to, drug regimen review
and verification of accurate prescription data entry, including prescriptions
placed on hold, packaging, preparation, compounding, transferring, labeling,
and performance of the final check of the dispensed prescription. An intern has
the same responsibilities described in this subparagraph as a pharmacist but
must perform his or her duties under the supervision of a
pharmacist.
(2) Duties.
Duties which may only be performed by a pharmacist are as follows:
(A) receiving oral prescription drug orders
for controlled substances and reducing these orders to writing, either manually
or electronically;
(B) interpreting
prescription drug orders;
(C)
selecting drug products;
(D)
performing the final check of the dispensed prescription before delivery to the
patient to ensure that the prescription has been dispensed accurately as
prescribed;
(E) communicating to
the patient or patient's agent information about the prescription drug or
device which in the exercise of the pharmacist's professional judgment, the
pharmacist deems significant, as specified in §
291.33(c) of
this title;
(F) communicating to
the patient or the patient's agent on his or her request information concerning
any prescription drugs dispensed to the patient by the pharmacy;
(G) assuring that a reasonable effort is made
to obtain, record, and maintain patient medication records;
(H) interpreting patient medication records
and performing drug regimen reviews;
(I) performing a specific act of drug therapy
management for a patient delegated to a pharmacist by a written protocol from a
physician licensed in this state in compliance with the Medical Practice
Act;
(J) verifying that controlled
substances listed on invoices are received by clearly recording his/her
initials and date of receipt of the controlled substances; and
(K) transferring or receiving a transfer of
original prescription information for a controlled substance on behalf of a
patient.
(3) Special
requirements for compounding. All pharmacists engaged in compounding
non-sterile preparations shall meet the training requirements specified in
§
291.131 of this title (relating to
Pharmacies Compounding Non-Sterile Preparations).
(d) Pharmacy Technicians and Pharmacy
Technician Trainees.
(1) General.
(A) All pharmacy technicians and pharmacy
technician trainees shall meet the training requirements specified in §
297.6 of this title (relating to
Pharmacy Technician and Pharmacy Technician Trainee Training).
(B) Special requirements for compounding. All
pharmacy technicians and pharmacy technician trainees engaged in compounding
non-sterile preparations shall meet the training requirements specified in
§
291.131 of this title.
(2) Duties.
(A) Pharmacy technicians and pharmacy
technician trainees may not perform any of the duties listed in subsection
(c)(2) of this section.
(B) A
pharmacist may delegate to pharmacy technicians and pharmacy technician
trainees any nonjudgmental technical duty associated with the preparation and
distribution of prescription drugs provided:
(i) unless otherwise provided under §
291.33 of this subchapter, a
pharmacist verifies the accuracy of all acts, tasks, and functions performed by
pharmacy technicians and pharmacy technician trainees;
(ii) pharmacy technicians and pharmacy
technician trainees are under the direct supervision of and responsible to a
pharmacist; and
(iii) only pharmacy
technicians and pharmacy technician trainees who have been properly trained on
the use of an automated pharmacy dispensing system and can demonstrate
comprehensive knowledge of the written policies and procedures for the
operation of the system may be allowed access to the system.
(C) Pharmacy technicians and
pharmacy technician trainees may perform only nonjudgmental technical duties
associated with the preparation and distribution of prescription drugs, as
follows:
(i) initiating and receiving refill
authorization requests;
(ii)
entering prescription data into a data processing system;
(iii) taking a stock bottle from the shelf
for a prescription;
(iv) preparing
and packaging prescription drug orders (i.e., counting tablets/capsules,
measuring liquids and placing them in the prescription container);
(v) affixing prescription labels and
auxiliary labels to the prescription container;
(vi) reconstituting medications;
(vii) prepackaging and labeling prepackaged
drugs;
(viii) loading bulk
unlabeled drugs into an automated dispensing system provided a pharmacist
verifies that the system is properly loaded prior to use;
(ix) loading prepackaged containers
previously verified by a pharmacist or manufacturer's unit of use packages into
an automated dispensing system in accordance with §
291.33(i)(2)(D)(III)
of this subchapter;
(x) compounding non-sterile prescription drug
orders; and
(xi) compounding bulk
non-sterile preparations.
(D) In addition to the duties listed above in
subparagraph (C) of this paragraph, pharmacy technicians may perform the
following nonjudgmental technical duties associated with the preparation and
distribution of prescription drugs:
(i)
receiving oral prescription drug orders for dangerous drugs and reducing these
orders to writing, either manually or electronically;
(ii) transferring or receiving a transfer of
original prescription information for a dangerous drug on behalf of a patient;
and
(iii) contacting a prescriber
for information regarding an existing prescription for a dangerous
drug.
(3) Ratio
of on-site pharmacists to pharmacy technicians and pharmacy technician
trainees.
(A) Except as provided in
subparagraphs (B) and (C) of this paragraph, the ratio of on-site pharmacists
to pharmacy technicians and pharmacy technician trainees may be 1:6, provided
the pharmacist is on-site and a maximum of three of the six are pharmacy
technician trainees. The ratio of pharmacists to pharmacy technician trainees
may not exceed 1:3.
(B)
Subparagraph (A) of this paragraph does not apply to a central fill pharmacy,
as defined in §
291.125 of this title (relating to
Centralized Prescription Dispensing), that has no patient-facing contact. For
purposes of this subparagraph, patient-facing contact means any direct
interaction between a pharmacy employee and a patient or patient's
agent.
(C) As specified in
§568.006 of the Act, a Class A pharmacy may have a ratio of on-site
pharmacists to pharmacy technicians/pharmacy technician trainees of 1:5
provided:
(i) the Class A pharmacy:
(I) dispenses no more than 20 different
prescription drugs; and
(II) does
not produce sterile preparations including intravenous or intramuscular drugs
on-site; and
(ii) the
following conditions are met:
(I) at least
four are pharmacy technicians and not pharmacy technician trainees;
and
(II) the pharmacy has written
policies and procedures regarding the supervision of pharmacy technicians and
pharmacy technician trainees, including requirements that the pharmacy
technicians and pharmacy technician trainees included in a 1:5 ratio may be
involved only in one process at a time. For example, a technician/trainee who
is compounding non-sterile preparations or who is involved in the preparation
of prescription drug orders may not also call physicians for authorization of
refills.
(e) Identification of pharmacy personnel. All
pharmacy personnel shall be identified as follows.
(1) Pharmacy technicians. All pharmacy
technicians shall wear an identification tag or badge that bears the person's
name and identifies him or her as a pharmacy technician, or a certified
pharmacy technician, if the technician maintains current certification with the
Pharmacy Technician Certification Board or any other entity providing an
examination approved by the board.
(2) Pharmacy technician trainees. All
pharmacy technician trainees shall wear an identification tag or badge that
bears the person's name and identifies him or her as a pharmacy technician
trainee.
(3) Pharmacist interns.
All pharmacist interns shall wear an identification tag or badge that bears the
person's name and identifies him or her as a pharmacist intern.
(4) Pharmacists. All pharmacists shall wear
an identification tag or badge that bears the person's name and identifies him
or her as a pharmacist.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
(a) Pharmacist-in-charge .
(1) General.
(A) Each Class A pharmacy shall have one pharmacist-in-charge who is employed on a full-time basis and who may be the pharmacist-in-charge for only one such pharmacy; provided, however, such pharmacist-in-charge may be the pharmacist-in-charge of:
(i) more than one Class A pharmacy, if the additional Class A pharmacies are not open to provide pharmacy services simultaneously; or
(ii) during an emergency, up to two Class A pharmacies open simultaneously if the pharmacist-in-charge works at least 10 hours per week in each pharmacy for no more than a period of 30 consecutive days.
(B) The pharmacist-in-charge shall comply with the provisions of § 291.17 of this title (relating to Inventory Requirements).
(C) The pharmacist-in-charge of a Class A pharmacy may not serve as the pharmacist-in-charge of a Class B pharmacy or a Class C pharmacy with 101 beds or more.
(2) Responsibilities. The pharmacist-in-charge shall have responsibility for the practice of pharmacy at the pharmacy for which he or she is the pharmacist-in-charge . The pharmacist-in-charge may advise the owner on administrative or operational concerns. The pharmacist-in-charge shall have responsibility for, at a minimum, the following:
(A) educating and training of pharmacy technicians and pharmacy technician trainees;
(B) supervising a system to assure appropriate procurement of prescription drugs and devices and other products dispensed from the Class A pharmacy;
(C) disposing of and distributing drugs from the Class A pharmacy;
(D) storing all materials, including drugs, chemicals, and biologicals;
(E) maintaining records of all transactions of the Class A pharmacy necessary to maintain accurate control over and accountability for all pharmaceutical materials required by applicable state and federal laws and sections;
(F) supervising a system to assure maintenance of effective controls against the theft or diversion of prescription drugs, and records for such drugs;
(G) adhering to policies and procedures regarding the maintenance of records in a data processing system such that the data processing system is in compliance with Class A pharmacy requirements;
(H) legally operating the pharmacy, including meeting all inspection and other requirements of all state and federal laws or sections governing the practice of pharmacy; and
(I) if the pharmacy uses an automated pharmacy dispensing system , shall be responsible for the following:
(i) consulting with the owner concerning and adherence to the policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;
(ii) inspecting medications in the automated pharmacy dispensing system , at least monthly, for expiration date, misbranding, physical integrity, security, and accountability;
(iii) assigning, discontinuing, or changing personnel access to the automated pharmacy dispensing system ;
(iv) ensuring that pharmacy technicians, pharmacy technician trainees, and licensed healthcare professionals performing any services in connection with an automated pharmacy dispensing system have been properly trained on the use of the system and can demonstrate comprehensive knowledge of the written policies and procedures for operation of the system; and
(v) ensuring that the automated pharmacy dispensing system is stocked accurately and an accountability record is maintained in accordance with the written policies and procedures of operation.
(b) Owner. The owner of a Class A pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist , the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist :
(1) establishing policies for procurement of prescription drugs and devices and other products dispensed from the Class A pharmacy;
(2) establishing policies and procedures for the security of the prescription department including the maintenance of effective controls against the theft or diversion of prescription drugs;
(3) if the pharmacy uses an automated pharmacy dispensing system , reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;
(4) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and
(5) establishing policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.
(c) Pharmacists.
(1) General.
(A) The pharmacist-in-charge shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the Class A pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.
(B) All pharmacists shall assist the pharmacist-in-charge in meeting his or her responsibilities in ordering, dispensing, and accounting for prescription drugs.
(C) Pharmacists are solely responsible for the direct supervision of pharmacy technicians and pharmacy technician trainees and for designating and delegating duties, other than those listed in paragraph (2) of this subsection, to pharmacy technicians and pharmacy technician trainees. Each pharmacist shall be responsible for any delegated act performed by pharmacy technicians and pharmacy technician trainees under his or her supervision.
(D) Pharmacists shall directly supervise pharmacy technicians and pharmacy technician trainees who are entering prescription data into the pharmacy's data processing system by one of the following methods.
(i) Physically present supervision. A pharmacist shall be physically present to directly supervise a pharmacy technician or pharmacy technician trainee who is entering prescription data into the data processing system. Each prescription entered into the data processing system shall be verified at the time of data entry. If the pharmacist is not physically present due to a temporary absence as specified in § 291.33(b)(3) of this title (relating to Operational Standards), on return the pharmacist must:
(I) conduct a drug regimen review for the prescriptions data entered during this time period as specified in § 291.33(c)(2) of this title; and
(II) verify that prescription data entered during this time period was entered accurately.
(ii) Electronic supervision. A pharmacist may electronically supervise a pharmacy technician or pharmacy technician trainee who is entering prescription data into the data processing system provided the pharmacist :
(I) has the ability to immediately communicate directly with the technician/trainee;
(II) has immediate access to any original document containing prescription information or other information related to the dispensing of the prescription. Such access may be through imaging technology provided the pharmacist has the ability to review the original, hardcopy documents if needed for clarification; and
(III) verifies the accuracy of the data entered information prior to the release of the information to the system for storage and/or generation of the prescription label.
(iii) Electronic verification of data entry by pharmacy technicians or pharmacy technician trainees. A pharmacist may electronically verify the data entry of prescription information into a data processing system provided:
(I) the pharmacist has the ability to immediately communicate directly with the technician/trainee;
(II) the pharmacist electronically conducting the verification is either a:
(-a-) Texas licensed pharmacist ; or
(-b-) pharmacist employed by a Class E pharmacy that:
(-1-) has the same owner as the Class A pharmacy where the pharmacy technicians/trainees are located; or
(-2-) has entered into a written contract or agreement with the Class A pharmacy which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations;
(III) the pharmacy establishes controls to protect the privacy and security of confidential records; and
(IV) the pharmacy keeps permanent records of prescriptions electronically verified for a period of two years.
(E) All pharmacists, while on duty, shall be responsible for the legal operation of the pharmacy and for complying with all state and federal laws or rules governing the practice of pharmacy.
(F) A dispensing pharmacist shall be responsible for and ensure that the drug is dispensed and delivered safely and accurately as prescribed , unless the pharmacy's data processing system can record the identity of each pharmacist involved in a specific portion of the dispensing processing. If the system can track the identity of each pharmacist involved in the dispensing process, each pharmacist involved in the dispensing process shall be responsible for and ensure that the portion of the process the pharmacist is performing results in the safe and accurate dispensing and delivery of the drug as prescribed. The dispensing process shall include, but not be limited to, drug regimen review and verification of accurate prescription data entry, including prescriptions placed on hold, packaging, preparation, compounding, transferring, labeling, and performance of the final check of the dispensed prescription. An intern has the same responsibilities described in this subparagraph as a pharmacist but must perform his or her duties under the supervision of a pharmacist .
(2) Duties. Duties which may only be performed by a pharmacist are as follows:
(A) receiving oral prescription drug orders for controlled substances and reducing these orders to writing, either manually or electronically;
(B) interpreting prescription drug orders;
(C) selecting drug products;
(D) performing the final check of the dispensed prescription before delivery to the patient to ensure that the prescription has been dispensed accurately as prescribed ;
(E) communicating to the patient or patient's agent information about the prescription drug or device which in the exercise of the pharmacist 's professional judgment, the pharmacist deems significant, as specified in § 291.33(c) of this title;
(F) communicating to the patient or the patient's agent on his or her request information concerning any prescription drugs dispensed to the patient by the pharmacy;
(G) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;
(H) interpreting patient medication records and performing drug regimen reviews;
(I) performing a specific act of drug therapy management for a patient delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with the Medical Practice Act ;
(J) verifying that controlled substances listed on invoices are received by clearly recording his/her initials and date of receipt of the controlled substances; and
(K) transferring or receiving a transfer of original prescription information for a controlled substance on behalf of a patient.
(3) Special requirements for compounding. All pharmacists engaged in compounding non-sterile preparations shall meet the training requirements specified in § 291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations).
(d) Pharmacy Technicians and Pharmacy Technician Trainees.
(1) General.
(A) All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in § 297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).
(B) Special requirements for compounding. All pharmacy technicians and pharmacy technician trainees engaged in compounding non-sterile preparations shall meet the training requirements specified in § 291.131 of this title.
(2) Duties.
(A) Pharmacy technicians and pharmacy technician trainees may not perform any of the duties listed in subsection (c)(2) of this section.
(B) A pharmacist may delegate to pharmacy technicians and pharmacy technician trainees any nonjudgmental technical duty associated with the preparation and distribution of prescription drugs provided:
(i) unless otherwise provided under § 291.33 of this subchapter, a pharmacist verifies the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees;
(ii) pharmacy technicians and pharmacy technician trainees are under the direct supervision of and responsible to a pharmacist ; and
(iii) only pharmacy technicians and pharmacy technician trainees who have been properly trained on the use of an automated pharmacy dispensing system and can demonstrate comprehensive knowledge of the written policies and procedures for the operation of the system may be allowed access to the system.
(C) Pharmacy technicians and pharmacy technician trainees may perform only nonjudgmental technical duties associated with the preparation and distribution of prescription drugs, as follows:
(i) initiating and receiving refill authorization requests;
(ii) entering prescription data into a data processing system;
(iii) taking a stock bottle from the shelf for a prescription;
(iv) preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids and placing them in the prescription container);
(v) affixing prescription labels and auxiliary labels to the prescription container;
(vi) reconstituting medications;
(vii) prepackaging and labeling prepackaged drugs;
(viii) loading bulk unlabeled drugs into an automated dispensing system provided a pharmacist verifies that the system is properly loaded prior to use;
(ix) loading prepackaged containers previously verified by a pharmacist or manufacturer's unit of use packages into an automated dispensing system in accordance with § 291.33(i)(2)(D)(III) of this subchapter;
(x) compounding non-sterile prescription drug orders; and
(xi) compounding bulk non-sterile preparations.
(D) In addition to the duties listed above in subparagraph (C) of this paragraph, pharmacy technicians may perform the following nonjudgmental technical duties associated with the preparation and distribution of prescription drugs:
(i) receiving oral prescription drug orders for dangerous drugs and reducing these orders to writing, either manually or electronically;
(ii) transferring or receiving a transfer of original prescription information for a dangerous drug on behalf of a patient; and
(iii) contacting a prescriber for information regarding an existing prescription for a dangerous drug .
(3) Ratio of on-site pharmacists to pharmacy technicians and pharmacy technician trainees.
(A) Except as provided in subparagraph (B) of this paragraph, the ratio of on-site pharmacists to pharmacy technicians and pharmacy technician trainees may be 1:6, provided the pharmacist is on-site and a maximum of three of the six are pharmacy technician trainees . The ratio of pharmacists to pharmacy technician trainees may not exceed 1:3.
(B) As specified in §568.006 of the Act , a Class A pharmacy may have a ratio of on-site pharmacists to pharmacy technicians/pharmacy technician trainees of 1:5 provided:
(i) the Class A pharmacy:
(I) dispenses no more than 20 different prescription drugs; and
(II) does not produce sterile preparations including intravenous or intramuscular drugs on-site; and
(ii) the following conditions are met:
(I) at least four are pharmacy technicians and not pharmacy technician trainees; and
(II) the pharmacy has written policies and procedures regarding the supervision of pharmacy technicians and pharmacy technician trainees, including requirements that the pharmacy technicians and pharmacy technician trainees included in a 1:5 ratio may be involved only in one process at a time. For example, a technician/trainee who is compounding non-sterile preparations or who is involved in the preparation of prescription drug orders may not also call physicians for authorization of refills.
(e) Identification of pharmacy personnel. All pharmacy personnel shall be identified as follows.
(1) Pharmacy technicians. All pharmacy technicians shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician , or a certified pharmacy technician , if the technician maintains current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the board .
(2) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee .
(3) Pharmacist interns. All pharmacist interns shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist intern.
(4) Pharmacists. All pharmacists shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist .