| (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.
Cont'd... |
