As used in this chapter, the term:
(1.05) “Authorized” means, in the case of a wholesale distributor, having a valid license pursuant to this chapter or 21 U.S.C. Section 360eee-1(a)(6) and complying with the licensure reporting requirements under 21 U.S.C. Section 360eee-3(b).
(1.1) “Biological product” means a biological product as defined in subsection (i) of section 351 of the Public Health Service Act, 42 U.S.C. Section 262.
(3.1) “Cognizant member” means that member of the Georgia State Board of Pharmacy who is charged with conducting investigative interviews relating to investigations involving licensees, registrants, and permit holders.
Compounding also includes the preparation of drugs in anticipation of prescription drug orders based on routine and regularly observed prescribing patterns.
(14.05) “Durable medical equipment” means equipment for which a prescription is required, including repair and replacement parts for such equipment, and which:
(14.1) “Electronic data prescription drug order” means any digitalized prescription drug order transmitted to a pharmacy, by a means other than by facsimile, which contains the secure, personalized digital key, code, number, or other identifier used to identify and authenticate the prescribing practitioner in a manner required by state laws and board regulations and includes all other information required by state laws and board regulations. “Electronic data prescription drug order” also includes any digitalized prescription drug order transmitted to a pharmacy that is converted into a visual image of a prescription order during the transmission process, is received by the pharmacy through a facsimile, and includes the practitioner’s electronic signature.
(14.2) “Electronic data signature” means:
(14.3) “Electronic signature” means an electronic visual image signature or an electronic data signature of a practitioner which appears on an electronic prescription drug order.
(14.4) “Electronic visual image prescription drug order” means any exact visual image of a prescription drug order issued by a practitioner electronically and which bears an electronic reproduction of the visual image of the practitioner’s signature, is either printed on security paper and presented as a hard copy to the patient or transmitted by the practitioner via facsimile machine or equipment to a pharmacy, and contains all information required by state law and regulations of the board.
(14.5) “Electronic visual image signature” means any exact visual image of a practitioner’s signature reproduced electronically on a hard copy prescription drug order presented to the patient by the practitioner or is a prescription drug order transmitted to a pharmacy by a practitioner via facsimile machine or equipment.
(15.1) “Executive director” means the executive director appointed by the Georgia State Board of Pharmacy pursuant to Code Section 26-4-20.
(18.05) “Hard copy prescription drug order” means a written, typed, reproduced, or printed prescription drug order prepared on a piece of paper.
(18.1) “Institution” means any licensed hospital, nursing home, assisted living community, personal care home, hospice, health clinic, or prison clinic.
(18.2) “Interchangeable biological product” means a biological product that the federal Food and Drug Administration has determined meets the standards set forth in subsection (k)(4) of 42 U.S.C. Section 262 or has been deemed therapeutically equivalent by the federal Food and Drug Administration.
(23.5) “Narcotic treatment program clinic pharmacy” means a pharmacy which is attached to, located in, or otherwise a part of and operated by a narcotic treatment program which provides an opiate replacement treatment program, as designated or defined by the Department of Behavioral Health and Developmental Disabilities or such other state agency as may be designated as the state authority for the purposes of implementing the narcotic treatment program authorized by federal and state laws and regulations.
(24.1) “Outsourcing facility” means a facility that is engaged in the compounding of drugs and is registered with the federal Food and Drug Administration as an outsourcing facility pursuant to Section 503b of the federal act.
A pharmacist conducting such a test shall do so at a pharmacy or other facility that has obtained any necessary certification from or that is operating under a certificate of waiver from the federal Centers for Medicare and Medicaid Services pursuant to the federal Clinical Laboratory Improvement Amendments of 1998.
(37.1) “Remote automated medication system” means an automated mechanical system that is located in a skilled nursing facility or hospice licensed as such pursuant to Chapter 7 of Title 31 that does not have an on-site pharmacy and in which medication may be dispensed in a manner that may be specific to a patient.
(37.2) “Remote order entry” means the entry made by a pharmacist licensed in this state, who is an employee or contractor of a pharmacy licensed in this state or that holds a nonresident pharmacy permit issued pursuant to Code Section 26-4-114.1, from a remote location anywhere in the United States indicating that the pharmacist has reviewed the patient specific drug order for a hospital patient, has approved or disapproved the administration of the drug for such patient, and has entered the information in the hospital’s patient record system.
(38.5) “Security paper” means:
(40.1) “Third-party logistics provider” means an entity that provides or coordinates warehousing, distribution, or other services on behalf of a manufacturer, wholesale distributor, or chain pharmacy but does not take title to a drug or have general responsibility to direct the sale or other disposition of the drug.
(40.5) “USP-NF” means the United States Pharmacopeia and National Formulary.
History. Code 1981, § 26-4-5 , enacted by Ga. L. 1998, p. 686, § 1; Ga. L. 1999, p. 81, § 26; Ga. L. 1999, p. 277, § 1.1; Ga. L. 2000, p. 1706, § 22; Ga. L. 2004, p. 738, §§ 2, 3; Ga. L. 2007, p. 47, § 26/SB 103; Ga. L. 2009, p. 453, § 3-2/HB 228; Ga. L. 2010, p. 266, § 1/SB 195; Ga. L. 2011, p. 227, § 7/SB 178; Ga. L. 2011, p. 308, § 5/HB 457; Ga. L. 2011, p. 659, § 3/SB 36; Ga. L. 2012, p. 1092, § 1A/SB 346; Ga. L. 2013, p. 127, § 1/HB 209; Ga. L. 2013, p. 192, § 1-1/HB 132; Ga. L. 2015, p. 5, § 26/HB 90; Ga. L. 2015, p. 585, § 1/SB 194; Ga. L. 2015, p. 1209, § 1/SB 51; Ga. L. 2016, p. 855, § 1/HB 926; Ga. L. 2017, p. 614, § 1/SB 41; Ga. L. 2018, p. 132, § 1/HB 769; Ga. L. 2019, p. 1056, § 26/SB 52; Ga. L. 2021, p. 472, § 4/HB 93; Ga. L. 2021, p. 525, § 1/HB 653.
The 2012 amendment, effective July 1, 2012, added paragraph (37.2).
The 2013 amendments.
The first 2013 amendment, effective July 1, 2013, substituted the present provisions of paragraph (4) for the former provisions, which read: “ ‘Compounding’ means the preparation, mixing, assembling, packaging, or labeling of a drug or device 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.”; in paragraph (38.5), added a colon following “means” near the beginning, substituted “(A) A prescription” for “a prescription”, redesignated former subparagraphs (38.5)(A) through (38.5)(C) as present divisions (38.5)(A)(i) through (38.5)(A)(iii), respectively, substituted “; or” for a period at the end in division (38.5)(A)(iii), deleted the ending undesignated paragraph following division (38.5)(A)(iii), which read: “Where security paper is in the form of a prescription pad, each pad shall bear an identifying lot number, and each piece of paper in the pad shall be numbered sequentially beginning with the number one.”, and added paragraph (38.5)(B); and added paragraph (40.5). The second 2013 amendment, effective July 1, 2013, added paragraph (3.1); deleted former paragraph (11.1), which read: “ ‘Division director’ means the division director of the professional licensing boards division, as provided in Chapter 1 of Title 43.”; and added paragraph (15.1).
The 2015 amendments.
The first 2015 amendment, effective March 13, 2015, part of an Act to revise, modernize, and correct the Code, corrected a misspelling of “similar” in paragraph (9). The second 2015 amendment, effective July 1, 2015, inserted “optometrist,” in paragraph (33). The third 2015 amendment, effective July 1, 2015, added paragraphs (1.1) and (18.2).
The 2016 amendment, effective July 1, 2016, added paragraphs (1.05), (24.1), and (40.1).
The 2017 amendment, effective July 1, 2017, added paragraph (14.05).
The 2018 amendment, effective January 1, 2019, in the middle of paragraph (37.2), substituted “licensed in this state, who is an employee or contractor of a pharmacy licensed in this state or that holds a nonresident pharmacy permit issued pursuant to Code Section 26-4-114.1,” for “located within the State of Georgia” and inserted “anywhere in the United States”.
The 2019 amendment, effective May 12, 2019, part of an Act to revise, modernize, and correct the Code, inserted “Section” following “21 U.S.C.” in two places in paragraph (1.05).
The 2021 amendments.
The first 2021 amendment, effective July 1, 2021, rewrote paragraph (31). The second 2021 amendment, effective July 1, 2021, substituted the present provisions of paragraph (31) for the former provisions, which read: “ ‘Pharmacy care’ means those services related to the interpretation, evaluation, or dispensing of prescription drug orders, the participation in drug and device selection, drug administration, and drug regimen reviews, and the provision of patient counseling related thereto.”
Code Commission notes.
Pursuant to Code Section 28-9-5, in 1998, “chapter” was substituted for “Chapter” in the first sentence of subparagraph (30)(B).
Pursuant to Code Section 28-9-5, in 2000, and due to the redesignation of paragraph (20) as paragraph (11.1), paragraph (20) has been set out as reserved.
Ga. L. 2021, p. 472, § 4/HB 93 and Ga. L. 2021, p. 525, § 1/HB 653 both amended paragraph (31) of this Code section. The language has been harmonized by setting out subparagraphs (31)(A) and (31)(B) as amended by Ga. L. 2021, p. 525, § 1/HB 653 and setting out the undesignated paragraph as amended by Ga. L. 2021, p. 472, § 4/HB 93.
Editor’s notes.
Ga. L. 2004, p. 738, § 1, not codified by the General Assembly, provides that: “This Act shall be known and may be cited as the ‘Patient Safe Prescription Drug Act.’ ”
For application of this statute in 2021, see Executive Orders 01.15.21.01, 01.29.21.02, 02.15.21.01, 02.26.21.02, 03.12.21.01, 03.31.21.03, 04.30.21.01, 05.28.21.02, 06.30.21.02, 07.22.21.02, 08.19.21.02, and 09.20.21.02.
A listing of Executive Orders issued in 2020 can be found at https://gov.georgia.gov/executive-action/executive-orders/2020-executive-orders.
U.S. Code.
The Clinical Laboratory Improvement Amendments, referred to in this Code section, was enacted by P. L. 100-578, 102 Stat. 2903. For a full classification of the codification, consult the USCS tables volume.
Law reviews.
For article on the 2011 amendment of this Code section, see 28 Ga. St. U.L. Rev. 269 (2011).