| (F) Drugs and/or devices may only be provided in prepackaged
quantities in suitable containers and/or original manufacturer's containers
which are appropriately labeled as set out in paragraphs (4) and (5)
of this subsection.
(G) Such drugs and/or devices shall be labeled by a
pharmacist licensed by the board; however, when drugs and/or devices
are provided under the supervision of a physician according to standing
delegation orders or standing medical orders, supportive personnel
may at the time of provision print on the label the following information
or affix an ancillary label containing the following information:
(i) patient's name; however, the patient's partner
or family member is not required to be on the label of a drug prescribed
for a partner for a sexually transmitted disease or for a patient's
family members if the patient has an illness determined by the Centers
for Disease Control and Prevention, the World Health Organization,
or the Governor's office to be pandemic;
(ii) any information necessary to complete the directions
for use in accordance with paragraph (4)(C)(ii) of this subsection;
(iii) date of provision; and
(iv) practitioner's name.
(H) Records of provision shall be maintained according
to §291.94(e) of this title.
(I) Controlled substances may not be provided or dispensed.
(J) Non-sterile preparations may only be provided by
the clinic pharmacy in accordance with §291.131 of this title
(relating to Pharmacies Compounding Non-sterile Preparations).
(7) Dispensing. Dangerous drugs may only be dispensed
by a pharmacist pursuant to a prescription order in accordance with
§§291.31 - 291.35 of this title (relating to Community Pharmacy
(Class A)) and §291.131 of this title.
(f) Pharmacy and therapeutics committee.
(1) The clinic pharmacy shall have a pharmacy and therapeutics
committee, which shall be composed of at least three persons and shall
include the pharmacist-in-charge, the medical director of the clinic,
and a person who is responsible for provision of drugs and devices.
(2) The pharmacy and therapeutics committee shall develop
the policy and procedure manual.
(3) The pharmacy and therapeutics committee shall meet
at least annually to:
(A) review and update the policy and procedure manual;
and
(B) review the retrospective drug utilization review
reports submitted by the pharmacist-in-charge if the clinic pharmacy
has an expanded formulary.
(g) Policies and procedures.
(1) Written policies and procedures shall be developed
by the pharmacy and therapeutics committee and implemented by the
pharmacist-in-charge.
(2) The policy and procedure manual shall include,
but not be limited to, the following:
(A) a current list of the names of the pharmacist-in-charge,
consultant-pharmacist, staff pharmacist(s), supportive personnel designated
to provide drugs or devices, and the supportive personnel designated
to supervise the day-to-day pharmacy related operations of the clinic
in the absence of the pharmacist;
(B) functions of the pharmacist-in-charge, consultant
pharmacist, staff pharmacist(s), and supportive personnel;
(C) objectives of the clinic;
(D) formulary;
(E) a copy of written agreement between the pharmacist-in-charge
and the clinic;
(F) date of last review/revision of policy and procedure
manual; and
(G) policies and procedures for:
(i) security;
(ii) equipment;
(iii) sanitation;
(iv) licensing;
(v) reference materials;
(vi) storage;
(vii) packaging-repackaging;
(viii) dispensing;
(ix) provision;
(x) retrospective drug regimen review;
(xi) supervision;
(xii) labeling-relabeling;
(xiii) samples;
(xiv) drug destruction and returns;
(xv) drug and device procuring;
(xvi) receiving of drugs and devices;
(xvii) delivery of drugs and devices;
(xviii) recordkeeping; and
(xix) inspection.
(h) Supervision. The pharmacist-in-charge, consultant
pharmacist, or staff pharmacist shall personally visit the clinic
on at least a monthly basis to ensure that the clinic is following
established policies and procedures. However, clinics operated by
state or local governments and clinics funded by government sources
money may petition the board for an alternative visitation schedule
under the following conditions.
(1) Such petition shall contain an affidavit with the
notarized signatures of the medical director, the pharmacist-in-charge,
and the owner/chief executive officer of the clinic, which states
that the clinic has a current policy and procedure manual on file,
has adequate security to prevent diversion of dangerous drugs, and
is in compliance with all rules governing Class D pharmacies.
(2) The board may consider the following items in determining
an alternative schedule:
(A) the degree of compliance on past compliance inspections;
(B) the size of the patient population of the clinic;
(C) the number and types of drugs contained in the
formulary; and
(D) the objectives of the clinic.
(3) Such petition shall be resubmitted every two years
in conjunction with the application for renewal of the pharmacy license.
|
| Source Note: The provisions of this §291.93 adopted to be effective January 7, 1987, 11 TexReg 5128; amended to be effective July 29, 1987, 12 TexReg 2339; amended to be effective February 17, 1988, 13 TexReg 613; amended to be effective September 14, 1988, 13 TexReg 4575; amended to be effective September 27, 1991, 16 TexReg 5071; amended to be effective January 29, 1992, 17 TexReg 324; amended to be effective March 25, 1999, 24 TexReg 2022; amended to be effective June 20, 2001, 26 TexReg 4513; amended to be effective March 12, 2003, 28 TexReg 2082; amended to be effective September 7, 2008, 33 TexReg 7242; amended to be effective September 9, 2012, 37 TexReg 6917;amendedtobe effective December 5, 2012, 37 TexReg 9513; amended to be effective March 19, 2017, 42 TexReg 1127; amended to be effective September 6, 2017, TexReg 4467 |
