| (ii) of suitable composition so that surfaces that
contact components, in-process material, or drug products shall not
be reactive, additive, or absorptive so as to alter the safety, identity,
strength, quality, or purity of the drug preparation beyond the desired
result;
(iii) cleaned and sanitized immediately prior to and
after each use; and
(iv) routinely inspected, calibrated (if necessary),
or checked to ensure proper performance;
(F) appropriate disposal containers for used needles,
syringes, etc., and if applicable, hazardous waste from the preparation
of hazardous drugs and/or biohazardous waste;
(G) appropriate packaging or delivery containers to
maintain proper storage conditions for sterile preparations;
(H) infusion devices, if applicable; and
(I) all necessary supplies, including:
(i) disposable needles, syringes, and other supplies
for aseptic mixing;
(ii) disinfectant cleaning solutions;
(iii) sterile 70% isopropyl alcohol;
(iv) sterile gloves, both for hazardous and non-hazardous
drug compounding;
(v) sterile alcohol-based or water-less alcohol based
surgical scrub;
(vi) hand washing agents with bactericidal action;
(vii) disposable, lint free towels or wipes;
(viii) appropriate filters and filtration equipment;
(ix) hazardous spill kits, if applicable; and
(x) masks, caps, coveralls or gowns with tight cuffs,
shoe covers, and gloves, as applicable.
(9) Labeling.
(A) Prescription drug or medication orders. In addition
to the labeling requirements for the pharmacy's specific license classification,
the label dispensed or distributed pursuant to a prescription drug
or medication order shall contain the following:
(i) the generic name(s) or the official name(s) of
the principal active ingredient(s) of the compounded sterile preparation;
(ii) for outpatient prescription orders other than
sterile radiopharmaceuticals, a statement that the compounded sterile
preparation has been compounded by the pharmacy. (An auxiliary label
may be used on the container to meet this requirement); and
(iii) a beyond-use date. The beyond-use date shall
be determined as outlined in Chapter 797, Pharmacy Compounding--Sterile
Preparations of the USP/NF, and paragraph (7)(G) of this subsection;
(B) Batch. If the sterile preparation is compounded
in a batch, the following shall also be included on the batch label:
(i) unique lot number assigned to the batch;
(ii) quantity;
(iii) appropriate ancillary instructions, such as storage
instructions or cautionary statements, including hazardous drug warning
labels where appropriate; and
(iv) device-specific instructions, where appropriate.
(C) Pharmacy bulk package. The label of a pharmacy
bulk package shall:
(i) state prominently "Pharmacy Bulk Package--Not for
Direct Infusion;"
(ii) contain or refer to information on proper techniques
to help ensure safe use of the preparation; and
(iii) bear a statement limiting the time frame in which
the container may be used once it has been entered, provided it is
held under the labeled storage conditions.
(10) Written drug information for prescription drug
orders only. Written information about the compounded preparation
or its major active ingredient(s) shall be given to the patient at
the time of dispensing a prescription drug order. A statement which
indicates that the preparation was compounded by the pharmacy must
be included in this written information. If there is no written information
available, the patient shall be advised that the drug has been compounded
and how to contact a pharmacist, and if appropriate, the prescriber,
concerning the drug. This paragraph does not apply to the preparation
of radiopharmaceuticals.
(11) Pharmaceutical Care Services. In addition to the
pharmaceutical care requirements for the pharmacy's specific license
classification, the following requirements for sterile preparations
compounded pursuant to prescription drug orders must be met. This
paragraph does not apply to the preparation of radiopharmaceuticals.
(A) Primary provider. There shall be a designated physician
primarily responsible for the patient's medical care. There shall
be a clear understanding between the physician, the patient, and the
pharmacy of the responsibilities of each in the areas of the delivery
of care, and the monitoring of the patient. This shall be documented
in the patient medication record (PMR).
(B) Patient training. The pharmacist-in-charge shall
develop policies to ensure that the patient and/or patient's caregiver
receives information regarding drugs and their safe and appropriate
use, including instruction when applicable, regarding:
(i) appropriate disposition of hazardous solutions
and ancillary supplies;
(ii) proper disposition of controlled substances in
the home;
(iii) self-administration of drugs, where appropriate;
(iv) emergency procedures, including how to contact
an appropriate individual in the event of problems or emergencies
related to drug therapy; and
(v) if the patient or patient's caregiver prepares
sterile preparations in the home, the following additional information
shall be provided:
(I) safeguards against microbial contamination, including
aseptic techniques for compounding intravenous admixtures and aseptic
techniques for injecting additives to premixed intravenous solutions;
(II) appropriate storage methods, including storage
durations for sterile pharmaceuticals and expirations of self-mixed
solutions;
(III) handling and disposition of premixed and self-mixed
intravenous admixtures; and
(IV) proper disposition of intravenous admixture compounding
supplies such as syringes, vials, ampules, and intravenous solution
containers.
(C) Pharmacist-patient relationship. It is imperative
that a pharmacist-patient relationship be established and maintained
throughout the patient's course of therapy. This shall be documented
in the patient's medication record (PMR).
(D) Patient monitoring. The pharmacist-in-charge shall
develop policies to ensure that:
(i) the patient's response to drug therapy is monitored
and conveyed to the appropriate health care provider;
(ii) the first dose of any new drug therapy is administered
in the presence of an individual qualified to monitor for and respond
to adverse drug reactions; and
(iii) reports of adverse events with a compounded sterile
preparation are reviewed promptly and thoroughly to correct and prevent
future occurrences.
(12) Drugs, components, and materials used in sterile
compounding.
(A) Drugs used in sterile compounding shall be a USP/NF
grade substances manufactured in an FDA-registered facility.
(B) If USP/NF grade substances are not available shall
be of a chemical grade in one of the following categories:
(i) Chemically Pure (CP);
(ii) Analytical Reagent (AR);
(iii) American Chemical Society (ACS); or
(iv) Food Chemical Codex.
(C) If a drug, component or material is not purchased
from a FDA-registered facility, the pharmacist shall establish purity
and stability by obtaining a Certificate of Analysis from the supplier
and the pharmacist shall compare the monograph of drugs in a similar
class to the Certificate of Analysis.
(D) All components shall:
(i) be manufactured in an FDA-registered facility;
or
(ii) in the professional judgment of the pharmacist,
be of high quality and obtained from acceptable and reliable alternative
sources; and
(iii) be stored in properly labeled containers in a
clean, dry area, under proper temperatures.
(E) Drug preparation containers and closures shall
not be reactive, additive, or absorptive so as to alter the safety,
identity, strength, quality, or purity of the compounded drug preparation
beyond the desired result.
(F) Components, drug preparation containers, and closures
shall be rotated so that the oldest stock is used first.
(G) Container closure systems shall provide adequate
protection against foreseeable external factors in storage and use
that can cause deterioration or contamination of the compounded drug
preparation.
Cont'd... |
