Current through Rules and Regulations filed through March 20, 2024
(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.
(d) The distribution of non-patient specific
compounded preparations for office use by a practitioner, excluding
veterinarians, is prohibited. This subsection shall not affect 503b outsourcing
facilities ability to provide non-patient specific compounded preparations for
office use by a practitioner. The distribution of compounded preparations, for
office administration or emergency dispensing, to a veterinarian 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.
1. "Emergency Dispensing" shall mean no more
than a 10-day supply dispensed for an urgent condition to an animal patient by
a licensed veterinarian with a valid veterinarian-client-patient relationship
when timely access to a compounding pharmacy is not available.
(e) 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.
(f) 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 Veterinarian.
(a) Only a
pharmacy licensed or registered by the Board may distribute compounded
preparations to veterinarians licensed in this state for administration or
emergency dispensing 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
veterinarian 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 veterinarian 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 veterinarian
for administration or emergency dispensing to their patients with the
following:
1. "By purchase order, Not by
prescription",
2. "For Office Use
Administration or Emergency Dispensing by a Veterinarian 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 veterinarian for the veterinarian's use and emergency
dispensing of the compounded preparation before providing any compounded
preparation to the veterinarian. The written agreement shall provide the
following information:
1. The name and address
of the veterinarian, license number and contact information.
2. An agreement by the veterinarian 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 except for a
case in which emergency dispensing is required.
3. An agreement by the veterinarian to
include on the patient's chart, or medication administration record the lot
number and beyond-use date of the compounded preparation administered or
dispensed 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 preparations to be provided to veterinarians for
use in patient care or when pharmacists are altering or repackaging such
products for veterinarians to use in patient care in the veterinarian's office,
the compounding shall be conducted as allowed by applicable federal law and
Board rules and shall be in compliance with USP-NF standards for
compounding.
(g) Pharmacists 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.
(h) 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
26-4-130shall comply with all the
provisions of this rule and other applicable Board laws, rules and
regulations.
O.C.G.A.
§§
26-4-4, 26-4-5, 26-4-27, 26-4-28, 26-4-86.
