(1) Applications for registration must be
filed with the Office of the Georgia State Board of Pharmacy ("Board") with the
(2) Registration of
a Researcher will be considered on the basis of the application filed and a
report from the director of the GDNA certifying the applicant possesses the
necessary qualifications for a permit.
(3) Application fees shall NOT be
(4) Permits shall not
be transferable. Permits become null and void upon the change of mode,
operation and/or location of the permit-holder.
(5) Permits are renewable every two (2) years
and expire on June 30th of the even- numbered years. Permits may be renewed
upon the payment of the required renewal fee and the filing of the renewal
application form. If the application is not made and the fee not pa id before
September 1st of the even-numbered year, the permit shall lapse and shall not
be renewable except by application f or a new permit.
The Board will consider the following
factors in determining eligibility for persons or entities applying for permits
to engage in research.
1. Any convictions of
the applicant under any Federal, State, or local laws related to dangerous
drugs or controlled substances;
Any felony convictions of the applicant under any Federal, State, or local
3. The applicant's past
experience in research related to dangerous drugs including controlled
4. The furnishing by
the applicant of false or fraudulent material in any application made in
connection with drug research;
Suspension or revocation by Federal, State or local government of any permit
currently or previously held by the applicant for drug research;
6. Compliance with the requirements under
previously granted permits or licenses, if any;
7. Compliance with requirements to maintain
and/or make available to the State licensing or permitting authority or to
Federal, State or local law enforcement officials those records required to be
maintained by researchers;
other factors or qualifications such as age, education, training, etc. the
Board considers relevant to be inconsistent with the public health and safety;
9. Having a Peace Officer
Certification suspended or revoked by the Georgia Peace Officers Standard and
Training (POST) or other professional licensing authority.
(b) The Board reserves the right to deny a
permit to any applicant if it deter mines that the granting of such a permit
would not be in the public interest.
Storage and Security:
(a) All drugs including dangerous drugs and
controlled substances shall be stored at appropriate temperatures and under
appropriate conditions in accordance with labeled requirements or those
published in the current edition of an official compendium, such as the United
States Pharmacopoeia (USP) Compendiums;
All facilities used for storage of drugs
including dangerous drugs and controlled substances shall be of suitable size
and construction to facilitate cleaning, maintenance and proper operations; and
shall provide security from unauthorized entry as approve d by the Board or
1. All such facilities will be located
in an appropriately zoned district, such as a college, school, university, law
enforcement off ice, or commercial area. No permit will be issued to any
researcher whose facility is located in a residential area, dwelling, or
location. The Board may choose to grant an exception to this rule upon receipt
of a written request from such applicant stating the reason for such an
Record Keeping and Accountability:
(a) Researchers shall establish and maintain
records of all transactions regarding receipt, distribution or other
disposition of dangerous drugs or controlled substances.
(b) All records required by these regulations
shall be retained for a minimum period of two (2) years following any
disposition of any drugs received.
(c) Such records shall be kept at the storage
site or shall be immediately retrievable by computers or other electronic means
for authorized inspection during the retention period.
Sanctions and Penalties:
The Board under these regulations shall
have the power to suspend or revoke any permit issued or to reprimand or to
fine, not to exceed $500 per violation, the holder of such permit when such
holder shall have:
1. Become unfit or
2. Been convicted of a
felony or any other crime involving moral turpitude;
3. Violated any Pharmacy laws or rules or
regulations promulgated by the Board, or violated any other state, federal, or
local laws and rules related to drugs.
4. The Board may refuse to grant a permit or
renewal to any person, firm, corporation, agency, department or other entity
for any of the grounds set forth in O.C.G.A. Section
and/or 26-4-60 of the Georgia Pharmacy Practice Act.
Ga. Comp. R. & Regs.
Original Rule entitled
"Researcher's Permit" adopted. F. Jan. 15,
1997; eff. Feb. 4, 1997.
F. Oct 27, 1998; eff.
November 16, 1998.
F. Aug. 6, 2001; eff.
Aug. 26, 2001.
F. Dec. 18, 2014; eff.
Jan. 7, 2015.