| (G) Hazardous drugs shall not be prepared as immediate
use compounded sterile preparations.
(4) Single-dose and multiple dose containers.
(A) Opened or needle punctured single-dose containers,
such as bags bottles, syringes, and vials of sterile products shall
be used within one hour if opened in worse than ISO Class 5 air quality.
Any remaining contents must be discarded.
(B) Single-dose containers, including single-dose large
volume parenteral solutions and single-dose vials, exposed to ISO
Class 5 or cleaner air may be used up to six hours after initial needle
puncture.
(C) Opened single-dose fusion sealed containers shall
not be stored for any time period.
(D) Multiple-dose containers may be used up to 28 days
after initial needle puncture unless otherwise specified by the manufacturer.
(5) Library. In addition to the library requirements
of the pharmacy's specific license classification, a pharmacy shall
maintain current or updated copies in hard-copy or electronic format
of each of the following:
(A) a reference text on injectable drug preparations,
such as Handbook on Injectable Drug Products;
(B) a specialty reference text appropriate for the
scope of pharmacy services provided by the pharmacy, e.g., if the
pharmacy prepares hazardous drugs, a reference text on the preparation
of hazardous drugs;
(C) the United States Pharmacopeia/National Formulary
containing USP Chapter 71, Sterility Tests, USP Chapter 85, Bacterial
Endotoxins Test, Pharmaceutical Compounding--Nonsterile Preparations,
USP Chapter 795, USP Chapter 797, Pharmaceutical Compounding--Sterile
Preparations, and USP Chapter 1163, Quality Assurance in Pharmaceutical
Compounding; and
(D) any additional USP/NF chapters applicable to the
practice of the pharmacy (e.g., USP Chapter 800, Hazardous Drugs--Handling
in Healthcare Settings, USP Chapter 823, Positron Emission Tomography
Drugs for Compounding, Investigational, and Research Uses).
(6) Environment. Compounding facilities shall be physically
designed and environmentally controlled to minimize airborne contamination
from contacting critical sites.
(A) Low and Medium Risk Preparations. A pharmacy that
prepares low- and medium-risk preparations shall have a clean room
for the compounding of sterile preparations that is constructed to
minimize the opportunities for particulate and microbial contamination.
The clean room shall:
(i) be clean, well lit, and of sufficient size to support
sterile compounding activities;
(ii) be maintained at a temperature of 20 degrees Celsius
or cooler and at a humidity below 60%;
(iii) be used only for the compounding of sterile preparations;
(iv) be designed such that hand sanitizing and gowning
occurs outside the buffer area but allows hands-free access by compounding
personnel to the buffer area;
(v) have non-porous and washable floors or floor covering
to enable regular disinfection;
(vi) be ventilated in a manner to avoid disruption
from the HVAC system and room cross-drafts;
(vii) have walls, ceilings, floors, fixtures, shelving,
counters, and cabinets that are smooth, impervious, free from cracks
and crevices (e.g., coved), non-shedding and resistant to damage by
disinfectant agents;
(viii) have junctures of ceilings to walls coved or
caulked to avoid cracks and crevices;
(ix) have drugs and supplies stored on shelving areas
above the floor to permit adequate floor cleaning;
(x) contain only the appropriate compounding supplies
and not be used for bulk storage for supplies and materials. Objects
that shed particles shall not be brought into the clean room. A Class
B pharmacy may use low-linting absorbent materials in the primary
engineering control device;
(xi) contain an ante-area that contains a sink with
hot and cold running water that enables hands-free use with a closed
system of soap dispensing to minimize the risk of extrinsic contamination.
A Class B pharmacy may have a sink with hot and cold running water
that enables hands-free use with a closed system of soap dispensing
immediately outside the ante-area if antiseptic hand cleansing is
performed using a waterless alcohol-based surgical hand scrub with
persistent activity following manufacturers' recommendations once
inside the ante-area; and
(xii) contain a buffer area. The following is applicable
for the buffer area:
(I) There shall be some demarcation designation that
delineates the ante-area from the buffer area. The demarcation shall
be such that it does not create conditions that could adversely affect
the cleanliness of the area;
(II) The buffer area shall be segregated from surrounding,
unclassified spaces to reduce the risk of contaminants being blown,
dragged, or otherwise introduced into the filtered unidirectional
airflow environment, and this segregation should be continuously monitored;
(III) A buffer area that is not physically separated
from the ante-area shall employ the principle of displacement airflow
as defined in Chapter 797, Pharmaceutical Compounding--Sterile Preparations,
of the USP/NF, with limited access to personnel; and
(IV) The buffer area shall not contain sources of water
(i.e., sinks) or floor drains other than distilled or sterile water
introduced for facilitating the use of heat block wells for radiopharmaceuticals.
(B) High-risk Preparations.
(i) In addition to the requirements in subparagraph
(A) of this paragraph, when high-risk preparations are compounded,
the primary engineering control shall be located in a buffer area
that provides a physical separation, through the use of walls, doors
and pass-throughs and has a minimum differential positive pressure
of 0.02 to 0.05 inches water column.
(ii) Presterilization procedures for high-risk level
compounded sterile preparations, such as weighing and mixing, shall
be completed in no worse than an ISO Class 8 environment.
(C) Automated compounding device.
(i) General. If automated compounding devices are used,
the pharmacy shall have a method to calibrate and verify the accuracy
of automated compounding devices used in aseptic processing and document
the calibration and verification on a daily basis, based on the manufacturer's
recommendations, and review the results at least weekly.
(ii) Loading bulk drugs into automated compounding
devices.
(I) Automated compounding devices may be loaded with
bulk drugs 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 an automated compounding device container
shall indicate the brand name and strength of the drug; or if no brand
name, then the generic name, strength, and name of the manufacturer
or distributor.
(III) Records of loading bulk drugs into an automated
compounding device shall be maintained to show:
(-a-) name of the drug, strength, and dosage form;
(-b-) manufacturer or distributor;
(-c-) manufacturer's lot number;
(-d-) manufacturer's expiration date;
(-e-) quantity added to the automated compounding device;
(-f-) date of loading;
(-g-) name, initials, or electronic signature of the
person loading the automated compounding device; and
(-h-) name, initials, or electronic signature of the
responsible pharmacist.
(IV) The automated compounding device shall not be
used until a pharmacist verifies that the system is properly loaded
and affixes his or her signature or electronic signature to the record
specified in subclause (III) of this clause.
(D) Hazardous drugs. If the preparation is hazardous,
the following is also applicable:
(i) Hazardous drugs shall be prepared only under conditions
that protect personnel during preparation and storage;
(ii) Hazardous drugs shall be stored separately from
other inventory in a manner to prevent contamination and personnel
exposure;
(iii) All personnel involved in the compounding of
hazardous drugs shall wear appropriate protective apparel, such as
gowns, face masks, eye protection, hair covers, shoe covers or dedicated
shoes, and appropriate gloving at all times when handling hazardous
drugs, including receiving, distribution, stocking, inventorying,
preparation, for administration and disposal;
(iv) Appropriate safety and containment techniques
for compounding hazardous drugs shall be used in conjunction with
aseptic techniques required for preparing sterile preparations;
(v) Disposal of hazardous waste shall comply with all
applicable local, state, and federal requirements;
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