| (VI) compounding low-risk sterile preparations pursuant
to medication orders provided the pharmacy technicians or pharmacy
technician trainees:
(-a-) have completed the training specified in §291.133
of this title; and
(-b-) are supervised by a pharmacist who has completed
the training specified in §291.133 of this title, and who conducts
in-process and final checks, and affixes his or her name, initials,
or electronic signature to the label or if batch prepared, to the
appropriate quality control records. (The name, initials, or electronic
signature are not required on the label if it is maintained in a permanent
record of the pharmacy.)
(C) Facilities with an ongoing clinical pharmacy program.
A Class C pharmacy with an ongoing clinical pharmacy program may allow
a pharmacy technician to verify the accuracy of the duties specified
in clause (ii) of this subparagraph when performed by another pharmacy
technician, under the following conditions:
(i) The pharmacy technician:
(I) is a registered pharmacy technician and not a pharmacy
technician trainee; and
(II) meets the training requirements specified in §297.6
of this title and the training requirements specified in paragraph
(1) of this subsection.
(ii) If the requirements of clause (i) of this subparagraph
are met, a pharmacy technician may verify the accuracy of the following
duties performed by another pharmacy technician:
(I) filling medication carts;
(II) distributing routine orders for stock supplies
to patient care areas; and
(III) accessing and restocking automated medication
supply systems after proper training on the use of the automated medication
supply system and demonstration of comprehensive knowledge of the
written policies and procedures for its operation; and
(iii) The patient's orders have previously been reviewed
and approved by a pharmacist.
(iv) A pharmacist is on duty in the facility at all
times that the pharmacy is open for pharmacy services.
(D) Rural Hospitals.
(i) A rural hospital may allow a pharmacy technician
to perform the duties specified in clause (ii) of this subparagraph
when a pharmacist is not on duty, if:
(I) the pharmacy technician:
(-a-) is a registered pharmacy technician and not a
pharmacy technician trainee; and
(-b-) meets the training requirements specified in §297.6
of this title and those specified in paragraph (1) of this subsection;
(II) a pharmacist is accessible at all times to respond
to any questions and needs of the pharmacy technician or other hospital
employees, by telephone, answering or paging service, e-mail, or any
other system that makes a pharmacist immediately accessible;
(III) the pharmacy is appropriately staffed to meet
the needs of the pharmacy; and
(IV) a nurse or practitioner at the rural hospital
or a pharmacist through electronic supervision as specified in paragraph
(2)(B)(ii) of this subsection, verifies the accuracy of the actions
of the pharmacy technician.
(ii) If the requirements of clause (i) of this subparagraph
are met, the pharmacy technician may, during the hours that the institutional
pharmacy in the hospital is open, perform the following duties in
the pharmacy without the direct supervision of a pharmacist:
(I) enter medication order and drug distribution information
into a data processing system;
(II) prepare, package, or label a prescription drug
according to a medication order if a licensed nurse or practitioner
verifies the accuracy of the order before administration of the drug
to the patient;
(III) fill a medication cart used in the rural hospital;
(IV) distribute routine orders for stock supplies to
patient care areas; and
(V) access and restock automated medication supply
cabinets.
(3) Procedures.
(A) Pharmacy technicians and pharmacy technician trainees
shall handle medication orders in accordance with standard, written
procedures and guidelines.
(B) Pharmacy technicians and pharmacy technician trainees
shall handle prescription drug orders in the same manner as those
working in a Class A pharmacy.
(f) Owner. The owner of a Class C 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 C pharmacy;
(2) establishing and maintaining 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.
(g) 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.
(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.
|
| Source Note: The provisions of this §291.73 adopted to be effective April 23, 1982, 7 TexReg 1469; amended to be effective September 14, 1988, 13 TexReg 4318; amended to be effective September 5, 1990, 15 TexReg 4810; amended to be effective September 27, 1991, 16 TexReg 5071; amended to be effective January 29, 1992, 17 TexReg 324; amended to be effective September 30, 1993, 18 TexReg 6460; amended to be effective March 16, 1995, 20 TexReg 1543; amended to be effective March 21, 1996, 21 TexReg 2242; amended to be effective October 11, 1996, 21 TexReg 9443; amended to be effective April 7, 1997, 22 TexReg 3106; amended to be effective September 16, 1999, 24 TexReg 7265; amended tobe effective June 4, 2000, 25 TexReg 4816; amended to be effective August 31, 2000, 25 TexReg 8406; amended to be effective December 27, 2000, 25 TexReg 12728; amended to be effective September 12, 2001, 26 TexReg 6923; amended to be effective September 8, 2002, 27 TexReg 8242; amended to be effective March 4, 2004, 29 TexReg 2000; amended to be effective June 6, 2004, 29 TexReg 5376; amended to be effective September 11, 2005, 30 TexReg 5366; amended to be effective September 18, 2007, 32 TexReg 6333; amended to be effective September 7, 2008, 33 TexReg 7241; amended to be effective September 20, 2009, 34 TexReg 6323; amended to be effective March 11, 2010, 35 TexReg 2005; amended to be effective May 30, 2010, 35 TexReg 4177; amended to be effective December 7, 2010, 35 TexReg 10693; amended to be effective December 6, 2015, 40 TexReg 8766; amended to be effective December 6, 2022,47 TexReg 8041 |
