| (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;
Cont'd... |
