| (iii) there is a reasonable method for the practitioner
to override any interchange; and
(iv) the practitioner authorizes pharmacists in the
facility 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.
(3) Prepackaging of drugs.
(A) Distribution within a facility.
(i) Drugs may be prepackaged in quantities suitable
for internal distribution 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:
(I) brand name and strength of the drug; or if no brand
name, then the generic name, strength, and name of the manufacturer
or distributor;
(II) facility's unique lot number;
(III) expiration date based on currently available
literature; and
(IV) quantity of the drug, if the quantity is greater
than one.
(iii) Records of prepackaging shall be maintained to
show:
(I) name of the drug, strength, and dosage form;
(II) facility's unique lot number;
(III) manufacturer or distributor;
(IV) manufacturer's lot number;
(V) expiration date;
(VI) quantity per prepackaged unit;
(VII) number of prepackaged units;
(VIII) date packaged;
(IX) name, initials, or electronic signature of the
prepacker; and
(X) name, initials, or electronic signature of the
responsible pharmacist.
(iv) Stock packages, prepackaged units, and control
records shall be quarantined together until checked/released by the
pharmacist.
(B) Distribution to other Class C (Institutional) pharmacies
under common ownership.
(i) Drugs may be prepackaged in quantities suitable
for distribution to other Class C (Institutional) pharmacies under
common ownership 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:
(I) brand name and strength of the drug; or if no brand
name, then the generic name, strength, and name of the manufacturer
or distributor;
(II) facility's unique lot number;
(III) expiration date based on currently available
literature;
(IV) quantity of the drug, if the quantity is greater
than one; and
(V) name of the facility responsible for prepackaging
the drug.
(iii) Records of prepackaging shall be maintained to
show:
(I) name of the drug, strength, and dosage form;
(II) facility's unique lot number;
(III) manufacturer or distributor;
(IV) manufacturer's lot number;
(V) expiration date;
(VI) quantity per prepackaged unit;
(VII) number of prepackaged units;
(VIII) date packaged;
(IX) name, initials, or electronic signature of the
prepacker;
(X) name, initials, or electronic signature of the
responsible pharmacist; and
(XI) name of the facility receiving the prepackaged
drug.
(iv) Stock packages, prepackaged units, and control
records shall be quarantined together until checked/released by the
pharmacist.
(v) The pharmacy shall have written procedure for the
recall of any drug prepackaged for another Class C pharmacy under
common ownership. The recall procedures shall require:
(I) notification to the pharmacy to which the prepackaged
drug was distributed;
(II) quarantine of the product if there is a suspicion
of harm to a patient;
(III) a mandatory recall if there is confirmed or probable
harm to a patient; and
(IV) notification to the board if a mandatory recall
is instituted.
(4) Sterile preparations prepared in a location other
than the pharmacy. A distinctive supplementary label shall be affixed
to the container of any admixture. The label shall bear at a minimum:
(A) patient's name and location, if not immediately
administered;
(B) name and amount of drug(s) added;
(C) name of the basic solution;
(D) name or identifying code of person who prepared
admixture; and
(E) expiration date of solution.
(5) Distribution.
(A) Medication orders.
(i) Drugs may be given to patients in facilities 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 (2)(C) of this subsection.
(ii) Drugs may be distributed only from the original
or a direct copy of the practitioner's medication order.
(iii) Pharmacy technicians and pharmacy technician
trainees may not receive oral medication orders.
(iv) Institutional 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.
(B) Procedures.
(i) Written policies and procedures for a drug distribution
system (best suited for the particular institutional pharmacy) shall
be developed and implemented by the pharmacist-in-charge, with the
advice of the committee performing the pharmacy and therapeutics function
for the facility.
(ii) The written policies and procedures for the drug
distribution system shall include, but not be limited to, procedures
regarding the following:
(I) pharmaceutical care services;
(II) handling, storage and disposal of cytotoxic drugs
and waste;
(III) disposal of unusable drugs and supplies;
(IV) security;
(V) equipment;
(VI) sanitation;
(VII) reference materials;
(VIII) drug selection and procurement;
(IX) drug storage;
(X) controlled substances;
(XI) investigational drugs, including the obtaining
of protocols from the principal investigator;
(XII) prepackaging and manufacturing;
(XIII) stop orders;
(XIV) reporting of medication errors, adverse drug
reactions/events, and drug product defects;
(XV) physician orders;
(XVI) floor stocks;
(XVII) drugs brought into the facility;
(XVIII) furlough medications;
(XIX) self-administration;
(XX) emergency drug supply;
(XXI) formulary;
(XXII) monthly inspections of nursing stations and
other areas where drugs are stored, distributed, administered or dispensed;
(XXIII) control of drug samples;
(XXIV) outdated and other unusable drugs;
(XXV) routine distribution of patient medication;
(XXVI) preparation and distribution of sterile preparations;
(XXVII) handling of medication orders when a pharmacist
is not on duty;
(XXVIII) use of automated compounding or counting devices;
(XXIX) use of data processing and direct imaging systems;
(XXX) drug administration to include infusion devices
and drug delivery systems;
(XXXI) drug labeling;
(XXXII) recordkeeping;
(XXXIII) quality assurance/quality control;
(XXXIV) duties and education and training of professional
and nonprofessional staff;
(XXXV) procedures for a pharmacy technician to verify
the accuracy of work performed by another pharmacy technician, if
applicable;
(XXXVI) operation of the pharmacy when a pharmacist
in not on-site; and
(XXXVII) emergency preparedness plan, to include continuity
of patient therapy and public safety.
Cont'd... |
