| (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.
Cont'd... |
