Chapter 480-11 PHARMACEUTICAL COMPOUNDING
| (1) |
"Administer" or
"administration" means the provision of a unit dose and/or doses of medication
to an individual patient as a result of the order of an authorized practitioner
of the healing arts. |
| (2) |
"Barrier
Isolator" means an isolator specifically designed for compounding
pharmaceutical ingredients or preparations in an aseptic environment. |
| (3) |
"Biological safety cabinet" means a
ventilated cabinet for personnel, product, and environmental protection having
an open front with inward airflow for personnel protection, downward HEPA
filtered laminar airflow for product protection, and
HEPA-filtered exhausted air for environmental
protection. |
| (4) |
"Board of Pharmacy"
or "Board" means the Georgia State Board of Pharmacy. |
| (5) |
"Class 100 Environment" or "ISO Class 5"
means an atmospheric environment which contains fewer than 100 particles 0.5
microns or larger in diameter per cubic meter of air. |
| (6) |
"Compounding" means the preparation,
mixing, assembling, packaging, or labeling of a drug or de vice as the result
of a practitioner's prescription drug order or initiative based on the
relationship between the practitioner, patient, and pharmacist in the course of
professional practice or for the purpose of, or as an incident to, research,
teaching, or chemical analysis and not for sale or dispensing. Compounding also
includes the preparation of drugs or devices in anticipation of prescription
drug orders based on routine and regularly observed prescribing patterns.
Compounding does not include mixing, reconstituting, or similar acts that are
performed in accordance with the directions contained in approved labeling
provided by the product's manufacturer and other manufacturer directions
consistent with that labeling. |
| (7) |
"Component" means any ingredient intended for use in the compounding of a drug
preparation, including those that may not appear in such preparation. |
| (8) |
"Cytotoxic" means a pharmaceutical that
has the capability of killing living cells. |
| (9) |
"Deliver" or "delivery" means the actual,
constructive, or attempted transfer of a drug or device from one person to
another, whether or not for a consideration. |
| (10) |
"Device" means an instrument, apparatus,
contrivance, or other similar or related article, including any component part
or accessory, which is required under federal law to bear the label,"Caution:
federal or state law requires dispensing by or on the order of a physician" or
"Rx Only." |
| (11) |
"Dispense" or
"dispensing" means the preparation and delivery of a drug or device to a
patient, patient's caregiver, or patient's agent pursuant to a lawful order of
a practitioner in a suitable container appropriately labeled for subsequent
administration to, or use by a patient. |
| (12) |
"Distribute" means the delivery of a
drug or device other than by administering or dispensing. |
| (13) |
"Drug" means:
| (a) |
Articles recognized as drugs in any
official compendium, or supplement thereto, designated from time to time by the
Board for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in humans or animals; |
| (b) |
Articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans or animals; |
| (c) |
Articles, other than food, intended to
affect the structure or any function of the body of humans or animals;
and |
| (d) |
Articles intended for use
as a component of any articles specified in subparagraph (a), (b), or (c) of
this paragraph but does not include devices. |
|
| (14) |
Drug regimen review includes but is not
limited to the following activities:
| (a) |
Evaluation of any prescription drug order and patient record for:
| 2. |
Rational
therapy-contraindications; |
| 3. |
Reasonable dose and route of administration; and |
| 4. |
Reasonable directions for use. |
|
| (b) |
Evaluation of any prescription
drug order and patient record for duplication of therapy; |
| (c) |
Evaluation of any prescription drug order
and patient record for the following interactions:
| 4. |
Adverse drug reactions. |
|
| (d) |
Evaluation of any prescription
drug order and patient record for proper utilization, including over
utilization or under utilization, and optimum therapeutic outcomes. |
|
| (15) |
"Enteral" means within or by
way of the intestine. |
| (16) |
"FDA"
means the United States Food and Drug Administration. |
| (17) |
"GDNA" means the Georgia Drugs and
Narcotics Agency. |
| (18) |
"Labeling"
means the process of preparing and affixing a label to any drug container
exclusive, however, of the labeling by a manufacturer, packer, or distributor
of a nonprescription drug or commercially packaged legend drug or device. Any
such label shall include all information required by federal and state law or
rule. |
| (19) |
"Nonprescription drug"
means a drug which may be sold without a prescription drug order and which is
labeled for use by the consumer in accordance with the requirements of the laws
and rules of this state and/or the federal government. |
| (20) |
"Parenteral" means an injectable sterile
preparation of drugs for administration by any other means than through the
gastrointestinal tract. |
| (21) |
"Patient counseling" means the oral communication by the pharmacist of
information, as defined in the law and the rules of the Board, to the patient,
patient's caregiver, or patient's agent, in order to improve therapy by
ensuring proper use of drugs and devices. |
| (22) |
"Pharmaceutical" means a compound to be
used as a medicinal drug. |
| (23) |
"Pharmacist" means an individual currently licensed by this state to engage in
the practice of pharmacy. This recognizes a pharmacist as a learned
professional who is authorized to provide patient services and pharmacy
care. |
| (24) |
"Pharmacist in charge"
means a pharmacist currently licensed in this state who accepts responsibility
for the operation of a pharmacy in conformance with all laws and rules
pertinent to the practice of pharmacy and the distribution of drugs and who is
personally in full and actual charge of such pharmacy and personnel. |
| (25) |
"Pharmacy" means any place licensed in
accordance with the laws and rules of this state wherein the possessing,
displaying, compounding, dispensing, or selling of drugs may be conducted,
including any and all portions of the building or structure leased, used, or
controlled by the licensee in the conduct of the business or profession
licensed by the Board at the address for which the license was
issued. |
| (26) |
"Practitioner" or
"practitioner of the healing arts" means a physician, dentist, podiatrist, or
veterinarian and shall include any other person licensed under the laws of this
state to use, mix, prepare, dispense, prescribe, and administer drugs in
connection with medical treatment to the extent provided by the laws of this
state. |
| (27) |
"Prescription drug
order" means a lawful order of a practitioner for a drug or device for a
specific patient. |
| (28) |
"Prospective
drug use review" means a review of the patient's drug therapy and prescription
drug order, as defined in the law and the rules of the Board, prior to
dispensing the drug as part of a drug regimen review. |
| (29) |
"Sterile pharmaceutical" means any
dosage form devoid of viable microorganisms, or any other contaminant
including, but not limited to, parenterals, injectables, and
ophthalmics. |
| (30) |
"Sterile
Preparations" are those as defined by USP 797. |
| (31) |
"USP-NF" means the United States
Pharmacopeia and National Formulary. |
| (1) |
Compounded drug preparations
-Pharmacist/Patient/Prescriber Relationship.
| (a) |
Based on the existence of a
pharmacist/patient/prescriber relationship and the presentation of a valid
prescription drug order or in anticipation of a prescription drug order based
on routine, regularly observed prescribing patterns, pharmacists may compound,
for an individual patient, drug preparations that are not commercially
available in the marketplace or commercially available in the place as outlined
by the restrictions under 12(b). Dispensing of pharmaceutical products shall be
consistent with the provisions of O.C.G.A. T. 16, Ch. 13 and T. 26, Ch. 4
relating to the issuance of prescriptions and the dispensing of
drugs. |
| (b) |
Pharmacists shall
receive, store, or use pharmaceuticals that have been manufactured or
repackaged in a FDA-registered facility. Pharmacists shall also receive, store,
or use pharmaceuticals in compounding preparations that meet official compendia
requirements. If neither of these requirements can be met, pharmacists shall
use their professional judgment to procure alternatives. |
| (c) |
Pharmacists may compound pharmaceuticals
prior to receiving a valid prescription drug order based on a history of
receiving valid prescription drug orders within an established
pharmacist/patient/prescriber relationship, and provided that they maintain the
prescriptions on file for all such preparations compounded at the pharmacy.
Preparations compounded in anticipation of a valid prescription drug order
shall be properly labeled to include the name of the compounded pharmaceutical,
date of compounding, and beyond-use date. The distribution of compounded
preparations, for office use by a practitioner, shall not exceed 5% of
production of compounded preparation in a calendar year by that pharmacy.
Amounts produced greater than 5% shall be considered manufacturing and will
require separate licensure as a manufacturer. Pharmacists must maintain a
separate compounding log for each compounded preparation that includes the
quantity and amount of each pharmaceutical that is compounded. Pharmacists
shall label all compounded preparations that are dispensed pursuant to a
prescription in accordance with the provisions of O.C.G.A. T. 16, Ch. 13 and
O.C.G.A. T. 26, Chs. 3 and 4, and Board rules and regulations, and shall
include on the labeling an appropriate beyond-use date as determined by the
pharmacist in compliance with USP-NF standards for pharmacy
compounding. |
| (d) |
All compounded
preparations labeled in accordance with Board rules and regulations regarding
pharmaceutical compounding shall be deemed to meet the labeling requirements of
O.C.G.A. T. 16, Ch. 13, and T. 26, Chs. 3 and 4. |
|
| (2) |
Compounded drug preparations - Pharmacist
for Distribution to Practitioner
| (a) |
Only a
pharmacy licensed or registered by the Board may distribute compounded
preparations to practitioners licensed in this state for administration to
their patients in the course of their professional practice, either personally
or by an authorized person under their direct and immediate
supervision. |
| (b) |
A practitioner
shall make a request to the pharmacy for a compounded preparation in the same
manner as ordering products from a wholesale pharmaceutical distributor or
manufacturer and not by using a prescription drug order. |
| (c) |
A pharmacy receiving an order from a
practitioner for a compounded preparation shall maintain such order with its
compounding records as required in Rule
480-11-.08 and other rules and
regulations of the Board. |
| (d) |
Pharmacists shall label all compounded preparations distributed to
practitioners for administration to their patients with the following:
| 1. |
"By purchase order, Not by
prescription", |
| 2. |
"For Office Use
Administration Only - Not for resale", |
| 3. |
The name of the active ingredients and
strengths contained in the compounded preparation, |
| 4. |
The lot number or identification of the
compounded preparation, |
| 5. |
The
pharmacy's name, address and telephone number, |
| 6. |
The initials of the pharmacist verifying
the finished compounded preparation and the date verified, |
| 7. |
The quantity, amount, size, or weight of
the compounded preparation in the container, |
| 8. |
An appropriate beyond-use (expiration)
date of the compounded preparation as determined by the pharmacist in
compliance with Board rule and USP-NF standards for pharmacy compounding,
and |
| 9. |
Appropriate ancillary
instructions such as storage instructions or cautionary statements, and where
appropriate, hazardous drug warning labels. |
|
| (e) |
Pharmacists shall enter into a written
agreement with a practitioner for the practitioner's use of the compounded
preparation before providing any compounded preparation to the practitioner.
The written agreement shall provide the following information:
| 1. |
The name and address of the practitioner,
license number and contact information. |
| 2. |
An agreement by the practitioner that the
compounded preparation may only be administered to the patient and may not be
dispensed to the patient or sold to any other person or entity. |
| 3. |
An agreement by the practitioner to
include on the patient's chart, or medication administration record the lot
number and beyond-use date of the compounded preparation administered to the
patient. |
| 4. |
The procedures for a
patient to report an adverse reaction or to submit a complaint about a
compounded preparation. |
| 5. |
The
procedure to be used when the pharmacy has to recall a batch of compounded
preparation. |
|
| (f) |
When
pharmacists are compounding sterile preparations to be provided to
practitioners for use in patient care or when pharmacists are altering or
repackaging such products for practitioners to use in patient care in the
practitioner's office, the sterile compounding shall be conducted as allowed by
applicable federal law and Board rules and shall be in compliance with USP-NF
standards for sterile compounding. |
| (g) |
Sterile compounded preparations may be
dispensed to practitioners in quantities no more than 100 individual dosage
containers and must have a beyond-use date no more than one week. |
| (h) |
Pharmacist may not compound Schedule II,
III, IV or V controlled substances, as defined in Article 2 of Chapter 13 of
Title 16 without a patient specific prescription drug order. |
| (i) |
Prior to any pharmacy engaging in the
practice of compounding preparations for use in the practitioner's office, the
pharmacy must notify the Georgia Drugs and Narcotic Agency ("GDNA") of its
practice, and must maintain on file the written acknowledgement of receipt of
the notice from GDNA. |
| (j) |
Nothing
in this paragraph shall be construed to apply to pharmacies owned or operated
by institutions or to pharmacists or practitioners employed by an institution
or its affiliated entities; provided, however, pharmacies owned or operated by
institutions and pharmacists and practitioners within or employed by
institutions or affiliated entities shall remain subject to the other rules and
regulations of the Board governing the compounding of
pharmaceuticals. |
|
| (3) |
Pharmacists must maintain documentation of proof that the beyond-use date on
compounded pharmaceuticals is valid. |
| (4) |
Pharmacists shall personally perform or
personally supervise the compounding process, which shall include a final
verification check for accuracy and conformity to the formula of the product
being prepared, correct ingredients and calculations, accurate and precise
measurements, appropriate conditions and procedures, and appearance of the
final product. |
| (5) |
Pharmacists
shall ensure compliance with USP-NF standards for both sterile and non-sterile
compounding. |
| (6) |
Pharmacists may
use prescription bulk substances in compounding when such bulk substances:
| (a) |
Comply with the standards of an
applicable USP-NF monograph, if such monograph exists, including the testing
requirements, and the Board rules on pharmaceutical compounding; or are
substances that are components of pharmaceuticals approved by the FDA for use
in the United States; or otherwise approved by the FDA; |
| (b) |
Are manufactured by an establishment that
is registered by the FDA; and |
| (c) |
Are distributed by a wholesale distributor licensed by the Board and registered
by the FDA to distribute bulk substances if the pharmacist can establish purity
and safety by reasonable means, such as lot analysis, manufacturer reputation,
or reliability of the source. |
|
| (7) |
Pharmacists shall maintain records of all
compounded pharmaceutical products. Pharmacist shall maintain a complete
compounding formula listing all procedures, necessary equipment, necessary
environmental considerations, and other factors in detail when such
instructions are necessary to replicate a compounded product or where the
compounding is difficult or complex and must be done by a certain process in
order to ensure the integrity of the finished product.
| (a) |
This record-keeping requirement does not
apply when FDA-approved and labeled sterile injectable drug products, produced
by registered pharmaceutical manufacturers, are reconstituted under conditions
as allowed by USP 797, and each such sterile drug product must be administered
within 24 hours of being reconstituted. |
|
| (8) |
Pharmacists engaged in the compounding of
pharmaceuticals shall operate in conformance with Georgia laws and regulations.
Non-sterile compounded preparations shall be subject to USP 795. All sterile
compounded preparations shall be subject to USP 797. |
| (9) |
Radiopharmaceuticals. If
radiopharmaceuticals are being compounded, conditions set forth in the Board's
rules for nuclear pharmacists and pharmacies must be followed. |
| (10) |
Special precaution preparations. If drug
preparations with special precautions for contamination are involved in a
compounding operation, appropriate measures, including either the dedication of
equipment for such operations or the meticulous cleaning of contaminated
equipment prior to its return to inventory, must be utilized in order to
prevent cross-contamination. |
| (11) |
Cytotoxic drugs. In addition to the minimum requirements for a pharmacy
established by rules of the Board, the following requirements are necessary for
those pharmacies that prepare cytotoxic drugs to insure the protection of the
personnel involved.
| (a) |
All cytotoxic drugs
should be compounded in a vertical flow, Class II, biological safety cabinet or
an appropriate barrier isolator. Other preparations should not be compounded in
this cabinet. |
| (b) |
Personnel
compounding cytotoxic drugs shall wear protective apparel as outlined in the
National Institute of Occupation Hazards (NIOSH.) in addition to appropriate
compounding attire as described in USP 797. |
| (c) |
Appropriate safety and containment
techniques for compounding cytotoxic drugs shall be used in conjunction with
the aseptic techniques required for preparing sterile preparations. |
| (d) |
Disposal of cytotoxic waste shall comply
with all applicable local, state, and federal requirements. |
| (e) |
Written procedures for handling both
major and minor spills of cytotoxic agents must be developed and must be
included in the policy and procedure manual. |
| (f) |
Prepared doses of cytotoxic drugs must be
dispensed, labeled with proper precautions inside and outside, and delivered in
a manner to minimize the risk of accidental rupture of the primary
container. |
| (g) |
Disposal of
cytotoxic and/or hazardous wastes. The pharmacist-in-charge is responsible for
assuring that there is a system for the disposal of cytotoxic and/or infectious
waste in a manner so as not to endanger the public health. |
|
| (12) |
Pharmacists shall not engage in the
following:
| (a) |
The compounding for human use
of a pharmaceutical product that has been withdrawn or removed from the market
by the FDA because such drug product or a component of such drug product has
been found to be unsafe. |
| (b) |
The
compounding of any pharmaceutical products that are essentially copies of
commercially available pharmaceutical products. However, this prohibition shall
not include:
| 1. |
The compounding of any
commercially available product when there is a change in the product ordered by
the prescriber for an individual patient, |
| 2. |
The compounding of a commercially
available manufactured pharmaceutical during times when the product is not
available from the manufacturer or wholesale distributor, |
| 3. |
The compounding of a commercially
manufactured pharmaceutical that appears on the drug shortages list,
or |
| 4. |
The mixing of two or more
commercially available products of which the end product is a commercially
available product. |
|
|
| (13) |
Practitioners who may lawfully compound
pharmaceuticals for administering or dispensing to their own patients pursuant
to O.C.G.A. Section
26-4-130 shall comply with all the
provisions of this rule and other applicable Board laws, rules and
regulations. |
| (1) |
The pharmacist has the responsibility and
authority to inspect and approve or reject all components, drug preparations
containers, closures, in-process materials, and labeling; and the authority to
prepare and review all compounding records to assure that no errors have
occurred in the compounding process. The pharmacist is also responsible for the
proper maintenance, cleanliness, and use of all equipment used in prescription
compounding practice. |
| (2) |
Pharmacists who engage in drug compounding, and any other pharmacy personnel,
supervised by pharmacists, who assist in drug compounding, shall be competent
and proficient in compounding procedures and shall maintain that proficiency
through current awareness and training and documentation of that training.
Every pharmacist who engages in drug compounding and any other pharmacy staff
member who assists in compounding, must be aware of and familiar with all
details of these good compounding practices. Records of documentation of
training for all personnel must be maintained for a minimum of five (5)
years. |
| (3) |
All pharmacy personnel
engaged in the compounding of drugs shall wear clean clothing appropriate to
the operation being performed. Protective apparel, such as coats/jackets,
aprons, gowns, hand or arm coverings, or masks shall be worn as necessary to
protect personnel from chemical exposure and drug preparations from
contamination. |
| (4) |
Only personnel
authorized by the responsible pharmacist shall be in the immediate vicinity of
the drug compounding operation. Any person known at any time (either by medical
examination or pharmacist determination) to have an apparent illness or open
lesions that may adversely affect the safety or quality of a drug preparation
being compounded shall be excluded from direct contact with components, drug
preparation containers, closures, in-process materials, and drug preparations
until the condition is corrected or determined by competent medical personnel
not to jeopardize the safety or quality of the preparations being compounded.
All personnel who assist the pharmacist in compounding procedures shall be
instructed to report to the pharmacist any health conditions that may have an
adverse effect on drug preparations. |
| (1) |
Facilities.
| (a) |
Pharmacies engaging in
compounding shall have an adequate area for the orderly compounding of
prescriptions, including the placement of equipment and materials. The drug
compounding area for sterile preparations shall be separate and distinct from
the area used for the compounding of non-sterile drug preparations. The area(s)
used for compounding of drugs shall be maintained in a good state of
repair. |
| (b) |
Bulk drugs and other
chemicals or materials used in the compounding of prescription drug orders must
be stored in adequately labeled containers in a clean, dry area or, if
required, under proper refrigeration. |
| (c) |
Adequate lighting and ventilation shall
be provided in all drug-compounding areas. Potable water shall be supplied
under continuous positive pressure in a plumbing system free of defects that
could contribute to contamination of any compounded drug preparation. Adequate
washing facilities, easily accessible to the compounding area(s) of the
pharmacy shall be provided. These facilities shall include, but not be limited
to, hot and cold water, soap or detergent, and air dryers or single-use
towels. |
| (d) |
Sewage, trash, and
other refuse in and from the pharmacy and immediate drug compounding area(s)
shall be disposed of in a safe and sanitary manner. |
|
| (2) |
Equipment.
| (a) |
Equipment used in the compounding of drug
preparation shall be of appropriate design, appropriate capacity, and suitably
located to facilitate operations for its intended use and for its cleaning and
maintenance. Equipment used in the compounding of drug preparations shall be of
suitable composition so that surfaces that contact components, in-process
materials, or drug preparations shall not be reactive, additive, or absorptive
so as to alter the safety, identity, strength, quality, or purity of the drug
preparation beyond that desired. |
| (b) |
Equipment and utensils used for
compounding shall be cleaned and sanitized immediately prior to use to prevent
contamination that would alter the safety, identity, strength, quality, or
purity of the drug preparation beyond that desired. In the case of equipment,
utensils, and containers/closures used in the compounding of sterile drug
preparations, cleaning, sterilization, and maintenance procedures as set forth
in Board Rules. |
| (c) |
Equipment and
utensils used for compounding drugs must be stored in a manner to protect them
from contamination. Immediately prior to the initiation of compounding
operations, they must be inspected by the pharmacist and determined to be
suitable for use. |
| (d) |
Automatic,
mechanical, electronic, or other types of equipment other than commercial scale
manufacturing or testing equipment, may be used in the compounding of drug
preparations. If such equipment is used, it shall be routinely inspected,
calibrated (if necessary), or checked to ensure proper performance. |
|
| (3) |
Physical requirements for
pharmacies compounding sterile parenteral preparations.
| (a) |
A pharmacy compounding or preparing
sterile parenteral preparations shall have a designated area for preparing
compounded, sterile parenteral preparations as defined in USP 797. This area
shall be physically separate from other areas and should be designed to avoid
unnecessary traffic and airflow disturbances. It shall be used only for the
preparation of sterile parental preparations. |
| (b) |
Equipment and supplies for compounding
sterile parenteral preparations. A pharmacy compounding sterile parenteral
preparations shall have the following minimum equipment and supplies:
| 1. |
Laminar airflow hood (ISO 5) located
within a clean room, or barrier isolator as described in USP 797; |
| 2. |
Infusion pumps, if appropriate; |
| 3. |
Sink, in working condition, with hot and
cold running water, which is convenient to the compounding area for the purpose
of hand scrubs prior to compounding; |
| 4. |
Facility for light/dark field
examination; |
| 5. |
Appropriate
disposal containers for used needles, syringes, etc., and if applicable,
cytotoxic waste from the preparation of chemotherapy agents; |
| 6. |
A Class II, vertical flow biological
safety cabinet or appropriate barrier isolator, if chemotherapy agents are
routinely prepared; |
| 7. |
Refrigerator/freezer in working condition; |
| 8. |
Class I or II electronic balance, or as
approved in writing by the Board; |
| 9. |
Disposable needles, syringes and other
supplies needed for aseptic admixture; |
| 10. |
Disinfectant cleaning
solutions; |
| 11. |
Handwashing agent
with bactericidal action; |
| 12. |
Disposable, lint free towels or an automatic hand dryer; |
| 13. |
Appropriate filters and filtration
equipment; |
| 14. |
Disposable masks and
sterile, disposable gloves, gowns, hair and shoe covers and goggles when
indicated; |
| 15. |
An oncology drug
spill kit, if chemotherapy agents are routinely prepared. |
| 16. |
For the purpose of emergency or immediate
patient care, compounded sterile preparations are exempted from the
requirements as outlined in USP 797. |
|
|
| (4) |
Minimum equipment for pharmacies
compounding non-sterile preparations.
| (a) |
A
compounding pharmacy must have all equipment required of a pharmacy in Chapter
480-10 of the Board Rules. |
| (b) |
Additionally, a compounding pharmacy must have the appropriate equipment for
use in compounding as defined in USP Chapters 795 and 797. |
|
| (5) |
References. In addition to references
required of a pharmacy, pharmacies compounding sterile pharmaceuticals shall
also have a current edition of or electronic access to an established reference
on IV stability and incompatibility, such as, Handbook on Injectable Drugs or
King's Guide to Parenteral Admixtures, current Federal requirements for sterile
compounding and other reference material including but not limited to:
| (a) |
"USP Pharmacists Pharmacopeia", |
|
| (6) |
Variances.
| (a) |
The pharmacist-in-charge may submit to
the Georgia State Board of Pharmacy a typed request for a variance to the
provisions relating to minimum equipment requirements. The reasons for the
request for a variance must be included in the submitted request. A variance
shall be granted by the Board only when, in the judgment of the Board, there
are sound reasons for doing so that relate to the necessary or efficient
delivery of health care. After consideration by the Board, the requestor will
be notified of the Board's decision in writing. |
| (b) |
If approved, said letter(s) will serve as
proof of the Board's approval for the variance indicated in the letter, and
must be posted next to the inspection report. |
|
| (1) |
For compounding of drugs in anticipation
of prescription drug orders:
| (a) |
There shall
be written procedures for the compounding of drug preparations to assure that
the finished preparations have the identity, strength, quality, and purity they
purport or are represented to possess. Such procedures shall include a listing
of the components (ingredients), their amounts (in weight or volume), the order
of component mixing, and a description of the compounding process. All
equipment and utensils and the container/closure system, relevant to the
sterility and stability of the intended use of the drug, shall be listed. These
written procedures shall be followed in the execution of the drug compounding
procedure. Nothing in these rules shall prohibit or exclude the use of
electronic or computer equipment to meet these requirements. |
| (b) |
Components for drug preparation
compounding shall be accurately weighed, measured, or subdivided as
appropriate. These operations should be checked and rechecked by the
compounding pharmacist at each stage of the process to ensure that each weight
or measure is correct as stated in the written compounding procedures. If a
component is transferred from the original container to another (e.g., a powder
is taken from the original container, weighed, placed/stored in an appropriate
container), the new container shall be appropriate and shall be identified with
the:
|
| (c) |
To assure the reasonable uniformity and
integrity of compounded drug preparations, written procedures shall be
established and followed that describe the tests or examinations to be
conducted on the preparation compounded (e.g., degree of weight variation among
capsules.) Such control procedures shall be established to monitor the output
and to validate the performance of those compounding processes that may be
responsible for causing variability in the final drug preparation. Such control
procedures shall include, but are not limited to, the following (where
appropriate):
| 1. |
Capsule weight
variation; |
| 2. |
Adequacy of mixing to
assure uniformity and homogeneity; |
| 3. |
Clarity, completeness, or pH of
solutions. |
|
| (d) |
Appropriate written procedures designed to prevent microbiological
contamination of compounded drug preparations purporting to be sterile shall be
established and followed. Such procedures shall include validation of any
sterilization process. |
| (e) |
All
personnel involved in any step of the compounding process shall be clearly
identified in the compounding record. The compounding record must document the
following:
| 1. |
The ingredients and amounts or
volumes used including the source, lot numbers and expiration dates; |
| 2. |
The order of the mixing or preparation of
the preparation including the date mixed; |
| 3. |
The identity of the pharmacist and any
staff member involved in each step of the procedure; and |
| 4. |
The pharmacy's lot or identification
number and expiration date for the compounded drug/ preparation if
applicable. |
|
|
| (2) |
Compounding of drugs for an individual
prescription drug order. The pharmacist must document in a readily retrievable
manner, the following information:
| (a) |
The
ingredients and lot numbers used in the compounding; |
| (b) |
The amounts (weights or volumes) of each
ingredient; |
| (c) |
The order of
component mixing; |
| (d) |
A description
of the compounding process; |
| (e) |
The
name of the responsible pharmacist and all other personnel involved in each
step of the compounding; and |
| (f) |
Appropriate written procedures designed to prevent microbiological
contamination if the compounded prescription is purported to be
sterile. |
|
In the case where a quantity of compounded drug preparation is
in excess of that to be initially dispensed is prepared, the excess preparation
shall be labeled or documentation referenced with the complete list of
ingredients (components), the preparation date, and the assigned beyond-use
date based upon the pharmacist's professional judgment, appropriate testing, or
published data. It shall also be stored and accounted for under conditions
dictated by its composition and stability characteristics (e.g., in a clean,
dry place on a shelf or in the refrigerator) to ensure its strength, quality,
and purity as outlined in Rule
480-11-.07.
| (1) |
Components,
drug preparation containers, closures, and bagged or boxed components of drug
preparation containers and closures used in the compounding of drugs shall be
handled and stored in a manner to prevent contamination and to permit
unhindered cleaning of the work area (e.g., floors) and inspection. |
| (2) |
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 beyond the
desired result. Components, drug preparation containers, and closures for use
in the compounding of drug preparations shall be rotated so that the oldest
stock is used first. 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. Drug
preparation containers and closures shall be clean and, where indicated by the
intended use of the drug, sterilized and processed to remove pyrogenic
properties to assure that they are suitable for their intended use. |
| (3) |
Drug preparation containers and closures
intended for the compounding of sterile preparations must be handled,
sterilized, processed and stored to remove pyrogenic properties to assure that
they are suitable for their intended purpose. Methods of cleaning, sterilizing,
and processing to remove pyrogenic properties shall be written and followed for
drug preparation containers and closures used in the preparation of sterile
pharmaceuticals. These processes shall be performed by pharmacists or under the
pharmacist's supervision. |
| (1) |
Any procedures or other records required to be maintained in compliance with
this chapter shall be retained for the same period of time as required in
chapter 480-10 of the Board Rules for the retention of prescription
files. |
| (2) |
All records required to
be retained under this chapter or copies of such records, shall be readily
available for authorized inspection during the retention period at the
establishment where the activities described in such records occurred. These
records or copies thereof shall be subject to photocopying or other means of
reproduction as part of any such inspection. |
| (3) |
Records required under this chapter may
be retained either as the original records or as true copies, such as
photocopies, microfilm, microfiche, electronic files or other accurate
reproductions of the original records. All records or reports must be
producible immediately if requested by the Board or an agent of the GDNA or
within forty-eight (48) hours if maintained in a central database. |
| (4) |
In addition to standard record and
reporting requirements, the following records and reports must be maintained
for sterile pharmaceuticals:
| (a) |
A policy and
procedure manual, including policies and procedures for cytotoxic and/or
infectious waste, if applicable; and |
| (b) |
Lot numbers and expiration dates of all
the components used in compounding sterile prescription drug orders. |
| (c) |
This record-keeping requirement does not
apply when FDA approved and labeled sterile injectable drug products, produced
by registered pharmaceutical manufacturers, are reconstituted under conditions
as allowed by USP 797, and each such sterile drug product must be administered
within 24 hours of being reconstituted. |
|
| (1) |
There shall be a documented, ongoing
quality assurance control program that monitors personnel performance,
equipment, and facilities. Appropriate samples of finished preparations shall
be examined to assure that the pharmacy is capable of consistently preparing
sterile pharmaceuticals meeting specifications.
| (a) |
All clean rooms, ante rooms, barrier
isolators and laminar flow hoods shall be certified following procedures such
as those outlined in the CETA Certification Guide for Sterile Compounding
Facilities (CAG-003-2005) should be performed by a qualified individual no less
than every six months whenever the device or room is relocated, altered, or
major service to the facility is performed. Appropriate documentation and
records shall be maintained. |
| (b) |
There shall be written procedures developed requiring sampling if microbial
contamination is suspected. |
| (c) |
If
bulk compounding of parenteral solutions is performed using non-sterile
chemicals, extensive end preparation testing must be documented prior to the
release of the preparation from quarantine. This process must include
appropriate tests for particulate matter and testing for pyrogens. |
| (d) |
There shall be documentation of quality
assurance audits at regular, planned intervals, including infection control and
sterile technique audits. |
|
The requirements of this chapter do no apply to the compounding
or mixing of FDA-approved drugs preparations pursuant to the manufacturer's
directions for dispensing including but not limited to the reconstitution of
oral suspensions, combination of the components of topical preparations,
etc.
