| (iii) FEMCF pharmacies may not sell, purchase, trade,
or possess prescription drug samples, unless the pharmacy meets the
requirements as specified in §291.16 of this title (relating
to Samples).
(iv) All drugs shall be stored at the proper temperatures,
as defined in the USP/NF and in §291.15 of this title (relating
to Storage of Drugs).
(v) Any drug bearing an expiration date may not be
dispensed or distributed beyond the expiration date of the drug.
(vi) Outdated drugs shall be removed from dispensing
stock and shall be quarantined together until such drugs are disposed
of.
(B) Formulary.
(i) A formulary may be developed by an appropriate
committee of the FEMCF.
(ii) The pharmacist-in-charge, consultant pharmacist,
or designee shall be a full voting member of any committee which involves
pharmaceutical services.
(iii) A practitioner may grant approval for pharmacists
at the FEMCF to interchange, in accordance with the facility's formulary,
for the drugs on the practitioner's medication orders provided:
(I) a formulary has been developed;
(II) the formulary has been approved by the medical
staff of the FEMCF;
(III) there is a reasonable method for the practitioner
to override any interchange; and
(IV) the practitioner authorizes a pharmacist in the
FEMCF to interchange on his/her medication orders in accordance with
the facility's formulary through his/her written agreement to abide
by the policies and procedures of the medical staff and facility.
(C) Prepackaging and loading drugs into automated medication
supply system.
(i) Prepackaging of drugs.
(I) Drugs may be prepackaged in quantities suitable
for internal distribution only by a pharmacist or by pharmacy technicians
or pharmacy technician trainees under the direction and direct supervision
of a pharmacist.
(II) The label of a prepackaged unit shall indicate:
(-a-) brand name and strength of the drug; or if no
brand name, then the generic name, strength, and name of the manufacturer
or distributor;
(-b-) facility's lot number;
(-c-) expiration date; and
(-d-) quantity of the drug, if quantity is greater
than one.
(III) Records of prepackaging shall be maintained to
show:
(-a-) the name of the drug, strength, and dosage form;
(-b-) facility's lot number;
(-c-) manufacturer or distributor;
(-d-) manufacturer's lot number;
(-e-) expiration date;
(-f-) quantity per prepackaged unit;
(-g-) number of prepackaged units;
(-h-) date packaged;
(-i-) name, initials, or electronic signature of the
prepacker; and
(-j-) signature or electronic signature of the responsible
pharmacist.
(IV) Stock packages, repackaged units, and control
records shall be quarantined together until checked/released by the
pharmacist.
(ii) Loading bulk unit of use drugs into automated
medication supply systems. Automated medication supply systems may
be loaded with bulk unit of use drugs only by a pharmacist, by pharmacy
technicians or pharmacy technician trainees under the direction and
direct supervision of a pharmacist, or by a licensed nurse who is
authorized by the pharmacist to perform the loading of the automated
medication supply system. For the purpose of this clause, direct supervision
may be accomplished by physically present supervision or electronic
monitoring by a pharmacist. In order for the pharmacist to electronically
monitor, the medication supply system must allow for bar code scanning
to verify the loading of drugs, and a record of the loading must be
maintained by the system and accessible for electronic review by the
pharmacist.
(6) Medication orders.
(A) Drugs may be administered to patients in FEMCFs
only on the order of a practitioner. No change in the order for drugs
may be made without the approval of a practitioner except as authorized
by the practitioner in compliance with paragraph (5)(B) of this subsection.
(B) Drugs may be distributed only pursuant to the copy
of the practitioner's medication order.
(C) FEMCF pharmacies shall be exempt from the labeling
provisions and patient notification requirements of §562.006
and §562.009 of the Act, as respects drugs distributed pursuant
to medication orders.
(D) In FEMCFs with a full-time pharmacist, if a practitioner
orders a drug for administration to a bona fide patient of the facility
when the pharmacy is closed, the following is applicable:
(i) prescription drugs and devices only in sufficient
quantities for immediate therapeutic needs of a patient may be removed
from the FEMCF pharmacy;
(ii) only a designated licensed nurse or practitioner
may remove such drugs and devices;
(iii) a record shall be made at the time of withdrawal
by the authorized person removing the drugs and devices. The record
shall contain the following information:
(I) name of the patient;
(II) name of device or drug, strength, and dosage form;
(III) dose prescribed;
(IV) quantity withdrawn;
(V) time and date; and
(VI) signature or electronic signature of the person
making the withdrawal;
(iv) the medication order in the patient's chart may
substitute for such record, provided the medication order meets all
the requirements of clause (iii) of this subparagraph;
(v) the pharmacist shall verify the withdrawal of a
controlled substance as soon as practical, but in no event more than
72 hours from the time of such withdrawal; and
(vi) the pharmacist shall verify the withdrawal of
a dangerous drug at a reasonable interval, but such verification must
occur at least once in every calendar week.
(E) In FEMCFs with a part-time or consultant pharmacist,
if a practitioner orders a drug for administration to a bona fide
patient of the FEMCF when the pharmacist is not on duty, or when the
pharmacy is closed, the following is applicable:
(i) prescription drugs and devices only in sufficient
quantities for therapeutic needs may be removed from the FEMCF pharmacy;
(ii) only a designated licensed nurse or practitioner
may remove such drugs and devices;
(iii) a record shall be made at the time of withdrawal
by the authorized person removing the drug or device as described
in clauses (6)(D)(iii) and (iv) of this subsection; and
(iv) the pharmacist shall verify withdrawals at a reasonable
interval, but such verification must occur at least once in every
calendar week that the pharmacy is open.
(7) Floor stock. In facilities using a floor stock
method of drug distribution, the pharmacy shall establish designated
floor stock areas outside of the central pharmacy where drugs may
be stored, in accordance with the pharmacy's policies and procedures.
The following is applicable for removing drugs or devices in the absence
of a pharmacist:
(A) prescription drugs and devices may be removed from
the pharmacy only in the original manufacturer's container or prepackaged
container;
(B) only a designated licensed nurse or practitioner
may remove such drugs and devices;
(C) a record shall be made at the time of withdrawal
by the authorized person removing the drug or device and the record
shall contain the following information:
(i) name of the drug, strength, and dosage form;
(ii) quantity removed;
(iii) location of floor stock;
(iv) date and time; and
(v) signature or electronic signature of person making
the withdrawal;
(D) the medication order in the patient's chart may
substitute for the record required in subparagraph (C) of this paragraph,
provided the medication order meets all the requirements of subparagraph
(C) of this paragraph; and
(E) if a stored drug or device is returned to the pharmacy
from floor stock areas, a record shall be made by the authorized person
returning the drug or device. The record shall contain the following
information:
(i) drug name, strength, and dosage form, or device
name;
(ii) quantity returned;
(iii) previous floor stock location for the drug or
device;
(iv) date and time; and
Cont'd... |
