| (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).
(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;
Cont'd... |
