22 Tex. Admin. Code § 291.93 - Operational Standards
(a) Registration.
(1) Licensing requirements.
(A) All clinic pharmacies shall register with
the board on a pharmacy license application provided by the board, following
the procedures specified in §
291.1 of this title (relating to
Pharmacy License Application).
(B)
All clinic pharmacies shall provide a copy of their policy and procedure
manual, which includes the formulary, to the board with the initial license
application.
(C) The following fees
will be charged.
(i) A fee as specified in
§
291.6 of this title (relating to
Pharmacy License Fees) will be charged for the issuance of a new license and
for each renewal.
(ii) A pharmacy
operated by the state or a local government that qualifies for a Class D
license is not required to pay a fee to obtain a license.
(D) A Class D pharmacy which changes
ownership shall notify the board within ten days of the change of ownership and
apply for a new and separate license as specified in §
291.3 of this title (relating to
Required Notifications).
(E) A
clinic pharmacy shall notify the board in writing of any change in name or
location as specified in §
291.3 of this title.
(F) A separate license is required for each
principal place of business and only one pharmacy license may be issued to a
specific location.
(G) A clinic
pharmacy shall notify the board in writing within 10 days of a change of the
pharmacist-in-charge or staff pharmacist or consultant pharmacist.
(H) A Class D pharmacy shall notify the board
in writing within ten days of closing, following the procedures as specified in
§
291.5 of this title (relating to
Closing a Pharmacy).
(2)
Registration requirements for facilities that operate at temporary clinic
sites. A facility that operates a clinic at one or more temporary locations may
be licensed as a Class D pharmacy and provide dangerous drugs from these
temporary locations provided:
(A) the Class D
pharmacy complies with the registration requirements in paragraph (1) of this
subsection;
(B) the Class D
pharmacy has a permanent location where all dangerous drugs and records are
stored;
(C) no dangerous drugs are
stored or left for later pickup by the patient at the temporary location(s),
and all drugs are returned to the permanent location each day and stored:
(i) within the Class D pharmacy; or
(ii) within the pharmacy's mobile unit
provided the mobile clinic is parked at the location of the clinic pharmacy in
a secure area with adequate measures to prevent unauthorized access, and the
drugs are maintained at proper temperatures;
(D) the permanent location is the address of
record for the pharmacy;
(E) the
facility has no more than six temporary locations in operation
simultaneously;
(F) the Class D
pharmacy notifies the board of the locations of the temporary locations where
drugs will be provided and the schedule for operation of such clinics;
and
(G) the Class D pharmacy
notifies the board within 10 days of a change in address or closing of a
temporary location or a change in schedule of operation of a clinic.
(b) Environment.
(1) General requirements.
(A) The Class D pharmacy shall have a
designated area(s) for the storage of dangerous drugs and/or devices.
(B) No person may operate a pharmacy which is
unclean, unsanitary, or under any condition which endangers the health, safety,
or welfare of the public.
(C) The
Class D pharmacy shall comply with all federal, state, and local health laws
and ordinances.
(D) A sink with hot
and cold running water shall be available to all pharmacy personnel and shall
be maintained in a sanitary condition at all times.
(2) Security.
(A) Only authorized personnel may have access
to storage areas for dangerous drugs and/or devices.
(B) All storage areas for dangerous drugs
and/or devices shall be locked by key, combination, or other mechanical or
electronic means, so as to prohibit access by unauthorized
individuals.
(C) The
pharmacist-in-charge shall be responsible for the security of all storage areas
for dangerous drugs and/or devices including provisions for adequate safeguards
against theft or diversion of dangerous drugs and devices, and records for such
drugs and devices.
(D) The
pharmacist-in-charge shall consult with clinic personnel with respect to
security of the pharmacy, including provisions for adequate safeguards against
theft or diversion of dangerous drugs and/or devices, and records for such
drugs and/or devices.
(E)
Housekeeping and maintenance duties shall be carried out in the pharmacy, while
the pharmacist-in-charge, consultant pharmacist, staff pharmacist, or
supportive personnel is on the premises.
(c) Equipment. Each Class D pharmacy shall
maintain the following equipment and supplies:
(1) if the Class D pharmacy prepackages drugs
for provision:
(A) a typewriter or comparable
equipment; and
(B) an adequate
supply of child-resistant, moisture-proof, and light-proof containers and
prescription, poison, and other applicable identification labels used in
dispensing and providing of drugs;
(2) if the Class D pharmacy maintains
dangerous drugs requiring refrigeration and/or freezing, a refrigerator and/or
freezer;
(3) if the Class D
pharmacy compounds prescription drug orders, a properly maintained Class A
prescription balance (with weights) or equivalent analytical balance. It is the
responsibility of the pharmacist-in-charge to have such balance inspected at
least every three years by the appropriate authority as prescribed by local,
state, or federal law or regulations.
(d) Library. A reference library shall be
maintained which includes the following in hard copy or electronic format:
(1) current copies of the following:
(A) Texas Pharmacy Act and rules;
and
(B) Texas Dangerous Drug
Act;
(2) current copies
of at least two of the following references:
(A) Facts and Comparisons with current
supplements;
(B) AHFS Drug
Information;
(C) United States
Pharmacopeia Dispensing Information (USPDI);
(D) Physician's Desk Reference
(PDR);
(E) American Drug
Index;
(F) a reference text on drug
interactions, such as Drug Interaction Facts. A separate reference is not
required if other references maintained by the pharmacy contain drug
interaction information including information needed to determine severity or
significance of the interaction and appropriate recommendations or actions to
be taken;
(G) reference texts in
any of the following subjects: toxicology, pharmacology, or drug interactions;
or
(H) reference texts pertinent to
the major function(s) of the clinic.
(e) Drugs and devices.
(1) Formulary.
(A) Each Class D pharmacy shall have a
formulary which lists all drugs and devices that are administered, dispensed,
or provided by the Class D pharmacy.
(B) The formulary shall be limited to the
following types of drugs and devices, exclusive of injectable drugs for
administration in the clinic and nonprescription drugs, except as provided in
subparagraph (D) of this paragraph:
(i)
anti-infective drugs;
(ii)
musculoskeletal drugs;
(iii)
vitamins;
(iv) obstetrical and
gynecological drugs and devices;
(v) topical drugs; and
(vi) serums, toxoids, and vaccines.
(C) The formulary shall not
contain the following drugs or types of drugs:
(i) Nalbuphine (Nubain);
(ii) drugs used to treat erectile
dysfunction; and
(iii) Schedule I -
V controlled substances.
(D) Clinics with a patient population which
consists of at least 80% indigent patients may petition the board to operate
with a formulary which includes types of drugs and devices, other than those
listed in subparagraph (B) of this paragraph based upon documented objectives
of the clinic, under the following conditions.
(i) 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, and
include the following documentation:
(I) the
objectives of the clinic;
(II) the
total number of patients served by the clinic during the previous fiscal year
or calendar year;
(III) the total
number of indigent patients served by the clinic during the previous fiscal
year or calendar year;
(IV) the
percentage of clinic patients who are indigent, based upon the patient
population during the previous fiscal year or calendar year;
(V) the proposed formulary and the need for
additional types of drugs based upon objectives of the clinic; and
(VI) if the provision of any drugs on the
proposed formulary require special monitoring, the clinic pharmacy shall submit
relevant sections of the clinic's policy and procedure manual regarding the
provision of drugs that require special monitoring.
(ii) Such petition shall be resubmitted every
two years in conjunction with the application for renewal of the pharmacy
license.
(I) Such renewal petition shall
contain the documentation required in clause (i) of this
subparagraph.
(II) If at the time
of renewal of the pharmacy license, the patient population for the previous
fiscal year or calendar year is below 80% indigent patients, the clinic shall
be required to submit an application for a Class A pharmacy license or shall
limit the clinic formulary to those types of drugs and devices listed in
subparagraph (B) of this paragraph.
(iii) If a Class D pharmacy wishes to add
additional drugs to the expanded formulary, the pharmacy shall petition the
board in writing prior to adding such drugs to the formulary. The petition
shall identify drugs to be added and the need for the additional drugs based
upon objectives of the clinic as specified in clause (i) of this
subparagraph.
(iv) The following
additional requirements shall be satisfied for clinic pharmacies with expanded
formularies.
(I) Supportive personnel who are
providing drugs shall be licensed nurses or practitioners.
(II) The pharmacist-in-charge, consultant
pharmacist, or staff pharmacist shall make on-site visits to the clinic at
least monthly.
(III) If the
pharmacy provides drugs which require special monitoring (i.e., drugs which
require follow-up laboratory work or drugs which should not be discontinued
abruptly), the pharmacy shall have policies and procedures for the provision of
the prescription drugs to patients and the monitoring of patients who receive
such drugs.
(IV) The
pharmacist-in-charge, consultant pharmacists, or staff pharmacists shall
conduct retrospective drug regimen reviews of a random sample of patients of
the clinic on at least a quarterly basis. The pharmacist-in-charge shall be
responsible for ensuring that a report regarding the drug regimen review,
including the number of patients reviewed, is submitted to the clinic's medical
director and the pharmacy and therapeutics committee of the clinic.
(V) If a pharmacy provides antipsychotic
drugs:
(-a-) a practitioner of the clinic
shall initiate the therapy;
(-b-) a
practitioner shall monitor and order ongoing therapy; and
(-c-) the patient shall be physically
examined by the practitioner at least on a yearly basis.
(v) The board may consider the
following items in approving or disapproving a petition for an expanded
formulary:
(I) the degree of compliance on
past compliance inspections;
(II)
the size of the patient population of the clinic;
(III) the number and types of drugs contained
in the formulary; and
(IV) the
objectives of the clinic.
(2) Storage.
(A) Drugs and/or devices which bear the words
"Caution, Federal Law Prohibits Dispensing without prescription" or "Rx only"
shall be stored in secured storage areas.
(B) All drugs shall be stored at the proper
temperatures, as defined in §
291.15 of this title (relating to
Storage of Drugs).
(C) Any drug or
device bearing an expiration date may not be provided, dispensed, or
administered beyond the expiration date of the drug or device.
(D) Outdated drugs or devices shall be
removed from stock and shall be quarantined together until such drugs or
devices are disposed.
(E)
Controlled substances may not be stored at the Class D pharmacy.
(3) Drug samples.
(A) Drug samples of drugs listed on the Class
D pharmacy's formulary and supplied by manufacturers shall be properly stored,
labeled, provided, or dispensed by the Class D pharmacy in the same manner as
prescribed by these sections for dangerous drugs.
(B) Samples of controlled substances may not
be stored, provided, or dispensed in the Class D pharmacy.
(4) Prepackaging and labeling for provision.
(A) Drugs may be prepackaged and labeled for
provision in the Class D pharmacy. Such prepackaging shall be performed by a
pharmacist or supportive personnel under the direct supervision of a pharmacist
and shall be for the internal use of the clinic.
(B) Drugs must be prepackaged in suitable
containers.
(C) The label of the
prepackaged unit shall bear:
(i) the name,
address, and telephone number of the clinic;
(ii) directions for use, which may include
incomplete directions for use provided:
(I)
labeling with incomplete directions for use has been authorized by the pharmacy
and therapeutics committee;
(II)
precise requirements for completion of the directions for use are developed by
the pharmacy and therapeutics committee and maintained in the pharmacy policy
and procedure manual; and
(III) the
directions for use are completed by practitioners, pharmacists, or licensed
nurses in accordance with the precise requirements developed under subclause
(II) of this clause;
(iii) name and strength of the drug--if
generic name, the name of the manufacturer or distributor of the
drug;
(iv) quantity;
(v) lot number and expiration date;
and
(vi) appropriate ancillary
label(s).
(D) Records of
prepackaging shall be maintained according to §
291.94(c) of
this title (relating to Records).
(5) Labeling for provision of drugs and/or
devices in an original manufacturer's container.
(A) Drugs and/or devices in an original
manufacturer's container shall be labeled prior to provision with the
information set out in paragraph (4)(C) of this subsection.
(B) Drugs and/or devices in an original
manufacturer's container may be labeled by:
(i) a pharmacist in a pharmacy licensed by
the board; or
(ii) supportive
personnel in a Class D pharmacy, provided the drugs and/or devices and control
records required by §
291.94(d) of
this title are quarantined together until checked and released by a
pharmacist.
(C) Records
of labeling for provision of drugs and/or devices in an original manufacturer's
container shall be maintained according to §
291.94(d) of
this title.
(6)
Provision.
(A) Drugs and devices may only be
provided to patients of the clinic.
(B) At the time of the initial provision, a
licensed nurse or practitioner shall provide verbal and written information to
the patient or patient's agent on side effects, interactions, and precautions
concerning the drug or device provided. If the provision of subsequent drugs is
delivered to the patient at the patient's residence or other designated
location, the following is applicable:
(i)
Written information as specified in subparagraph (B) of this paragraph shall be
delivered with the medication.
(ii)
The pharmacy shall maintain and use adequate storage or shipment containers and
use shipping processes to ensure drug stability and potency. Such shipping
processes shall include the use of appropriate packaging material and/or
devices to ensure that the drug is maintained at an appropriate temperature
range to maintain the integrity of the medication throughout the delivery
process.
(iii) The pharmacy shall
use a delivery system which is designed to ensure that the drugs are delivered
to the appropriate patient.
(C) The provision of drugs or devices shall
be under the continuous supervision of a pharmacist according to standing
delegation orders or standing medical orders and in accordance with written
policies and procedures and completion of the label as specified in
subparagraph (G) of this paragraph.
(D) Drugs and/or devices may only be provided
in accordance with the system of control and accountability for drugs and/or
devices provided by the clinic; such system shall be developed and supervised
by the pharmacist-in-charge.
(E)
Only drugs and/or devices listed in the clinic formulary may be
provided.
(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).
(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.
Notes
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