Ga. Comp. R. & Regs. R. 480-6-.02 - Nonresident Pharmacy Permit
(1) Effective April 1, 2015, it shall be
unlawful for any person, pharmacy, or facility located outside this state to
ship, mail, or deliver prescription drugs orders into this state or to
advertise its services, personally or through an in-state third party, unless
such person, pharmacy or facility holds a pharmacy license pursuant to O.C.G.A.
Section
26-4-110.1,
or holds a nonresident pharmacy permit pursuant to O.C.G.A. Section
26-4-114.1,
or is otherwise exempt from Georgia registration as a matter of Georgia
law.
(2) Application for a
non-resident pharmacy permit:
(a) Applications
must be filed with the Georgia State Board of Pharmacy located at 2 Peachtree
Street, NW, 6th Floor, Atlanta, Georgia 30303, along with the required
fee.
(b) The Board requires
information from each applicant for a nonresident pharmacy permit on its
application, including but not limited to, the following:
1. The name, full business address, and
telephone number of the applicant;
2. All trade or business names used by the
applicant;
3. Address, telephone
numbers, and the names of contact persons for each facility used by the
applicant for the records, storage, handling, and distribution of prescription
drugs into this state;
4. Address,
telephone number and name of agent of service for the applicant;
5. The type of ownership or operations (i.e.,
partnership, corporation, or sole proprietorship);
6. The name(s) of the owner and/or operator
of the pharmacy, including:
(i) If a person,
the name of the person;
(ii) If a
partnership, the name of each partner and the name of the
partnership;
(iii) If a
corporation, the name and title of each corporate officer and director, the
corporate names, and the name of the incorporation, and the name of the parent
company, if any; or
(iv) If a sole
proprietorship, the full name of the sole proprietorship and the name of the
business entity.
7. Where
operations are conducted at more than one location by a single pharmacy, each
such location shall be permitted by the Board;
8. Proof of a valid, unexpired license,
permit, or registration to operate a pharmacy in the compliance with the laws
and rules of each state in which the applicant receives and dispenses
prescription drug orders;
9. The
names and license numbers of the pharmacist-in-charge of each facility involved
in dispensing drugs to residents of this state and evidence that the
pharmacist(s) are licensed and in good standing in the state where they are
located;
10. Information necessary
to demonstrate compliance with O.C.G.A. T. 50, Ch. 36;
11. Evidence satisfactory to the Board that
the applicant in is compliance with all laws and investigations from each
regulatory or licensing agency in which the applicant holds a license;
and
12. If dispensing sterile or
nonsterile compounding for practitioners to use in patient care in the
practitioner's office, a copy of the most recent inspection report that is no
older than two (2) years before the date of application was submitted and which
is from an inspection conducted by the regulatory or licensing agencies of the
jurisdiction in which the applicant is located that indicates compliance with
the Board's rules and regulations and compliance with USP-NF standards for
pharmacies performing sterile and nonsterile compounding, or another inspection
approved by or conducted by the Board.
(3) Registration of a nonresident pharmacy
permit will be considered on the basis of the application filed with the Board,
fee paid, and a report from the Director of the GDNA certifying the applicant
possesses the necessary qualifications for a permit.
(4) Application fees and renewal fees shall
be set by the Board in a fee schedule and shall not be refundable.
(5) Permits may be denied for failure to
comply with rules of the Board, for failure to meet the minimum qualifications
for a permit, for the conviction by an owner or pharmacist of a felony
involving the practice of pharmacy or the distribution of drugs, for false
representations on an application, and for any other good cause related to
evidence of misfeasance or malfeasance by the applicant.
(6) Permits become null and void upon the
sale, transfer or change of mode of operation or location of the business.
Prior to the sale, transfer or change in mode of operation or the location of
the business, the nonresident pharmacy may apply for such change by submitting
a Board- approved application to the Board, and paying a fee. The permits of
nonresident pharmacies will not become void if proper application is made and
approved prior to the change.
(7)
Permits are issued for two years and expire on June 30th of each odd-numbered
year, and may be renewed for two years upon the payment of the required fee for
each place of business and the filing of a completed application for renewal.
Applicants for renewal must submit such evidence as requested by the Board
including, but not limited to evidence of certain inspection reports on
compounding and the status of the licenses of the pharmacy and pharmacists in
the state of location. If the application for renewal is not made and the fee
not paid before September 1st of the odd-numbered year, the permit shall lapse
and shall not be renewed, and an application for reinstatement shall be
required. Reinstatement is at the sole discretion of the Board.
(8) The denial of a nonresident pharmacy
permit and the denial of the renewal of a nonresident pharmacy permit shall not
be considered a contested case under the provisions of O.C.G.A. T. 50, Ch. 13,
but the applicant shall be entitled to an appearance before the
Board.
(9) Nonresident pharmacy
permit holders shall comply with all the recordkeeping requirements of the
state in which they are located and licensed for all prescriptions shipped,
mailed or delivered to patients or practitioners in the State of Georgia, but
shall be maintained a minimum of two (2) years. Nonresident pharmacy permit
holders shall notify the Board of each location where the required records are
being maintained, and such records must be readily retrievable and produced to
the Board within fifteen (15) business days, upon written request.
(10) In addition to labeling requirements
required by the state where the nonresident pharmacy is located, the permit
holders shall label the drugs dispensed with the following minimum information:
(a) The name and address of the
dispenser;
(b) The serial number
and date of the prescription or of its filling;
(c) The name of the prescriber;
(d) The name of the patient;
(e) The name of the drug dispensed;
(f) The direction for use and cautionary
statements; and
(g) Identification
of the pharmacist filling the prescription.
(11) Nonresident pharmacy permit holders
shall comply with the Board's rules and regulations on delivery of
prescriptions by mail in Board Chapter 480-48.
(12) Nonresident pharmacy permit holders
shall comply with the laws and rules and regulations of the state where such
pharmacies are located.
(13)
Nonresident pharmacy permit holders who compound drugs must comply with the
federal compounding laws as required in Board Chapter 480-11.
(14) Nonresident pharmacy permit holders
shall maintain a toll-free telephone number operational during the permit
holder's regular hours of operation, but not less than six days per week for a
minimum of 60 hours per week, in order to provide patient counseling. Such
toll-free number shall be capable of receiving inbound call from patients to
the permit holder, and such number shall be on file with Board and shall be
included on the label affixed to each container of all dispensed and
distributed drugs sent into the State of Georgia.
(15) Nonresident pharmacy permit holders must
notify the Board within five (5) business days of the receipt of any final
order or decision by any other licensing board or federal agency of the
imposition of disciplinary action or restriction by such other licensing board
or federal agency. A final order or decision includes a consent order or
agreement and is any decision, regardless whether there still exists an
appellate right to the state or federal courts. Any revocation or suspension of
a state or federal license or permit will result in the immediate suspension of
the nonresident pharmacy permit pending a final decision by the
Board.
(16) Within 72 hours,
nonresident permit holders must update the Board of any change in
pharmacist-in-charge of shipping into Georgia by completing forms provided by
the Board and including such pharmacist licensure information and criminal
history. Where a criminal background check cannot be completed within the
seventy-two (72 hours) contemplated by this section, nonresident pharmacy
permit holders must still update the Board of any change in
pharmacist-in-charge of shipping into Georgia by completing forms provided by
the Board and including such pharmacist licensure information, but shall have
up to fifteen (15) business days to provide criminal history
information.
(17) Nonresident
pharmacy permit holders shall cooperate with the Board in any investigation
involving prescription drugs distributed by such permit holder into this state
or related to the permit holder's compounding practices. The permit holder
shall respond within ten (10) business days to all communications from the
Board or its designee. Failure to respond or cooperate with the Board shall be
grounds for the immediate suspension of the nonresident pharmacy permit,
pending a hearing on further disciplinary action by the Board. Failure to
cooperate with the Board is grounds for disciplinary action by the
Board.
(18) Notices to nonresident
pharmacy permit holders shall be made on the agent of record with the Board. If
notices are returned as undeliverable or unclaimed, service shall be made on
the Executive Director, and any disciplinary proceedings shall proceed, or if a
final decision, the decision shall become effective.
(19) If, in the course of investigation of a
nonresident pharmacy permit holder or applicant, an onsite inspection by the
Board or its designee is required, the permit holder or applicant shall be
responsible for the cost of such onsite inspection.
(20) A nonresident pharmacy permit may be
revoked or suspended or otherwise disciplined for any reason that a permit may
be denied, for failure to comply with this rule, for disciplinary action by
other states and federal agencies, for conduct causing bodily or psychological
injuries to a resident of this state, and for failure to comply with Board laws
and other applicable rules as provided herein.
(21) If a nonresident pharmacy holder has an
affiliate as defined by O.C.G.A. §
26-4-119,
it shall annually file a disclosure statement identifying all such affiliates
no later than June 30 every year.
Notes
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