TITLE 26 FOOD, DRUGS, AND COSMETICS

Section 4. Pharmacists and Pharmacies, 26-4-1 through 26-4-214.

ARTICLE 2 STATE BOARD OF PHARMACY

26-4-28. Powers, duties, and authority.

1. The board shall have the power, duty, and authority for the control and regulation of the practice of pharmacy in the State of Georgia, including, but not limited to, the following:
   1. The licensing by examination or by license transfer of applicants who are qualified to engage in the practice of pharmacy under the provisions of this chapter;
   2. The renewal of licenses to engage in the practice of pharmacy;
   3. The establishment and enforcement of compliance with professional standards and rules of conduct of pharmacists engaged in the practice of pharmacy;
   4. The determination and issuance of standards for recognition and approval of degree programs of schools and colleges of pharmacy whose graduates shall be eligible for licensure in this state, and the specification and enforcement of requirements for practical training including internship;
   5. The enforcement of those provisions of this chapter relating to the conduct or competence of pharmacists practicing in this state and the suspension, revocation, or restriction of licenses to engage in the practice of pharmacy;
   6. The licensure and regulation of pharmacies and pharmacy interns;
   7. 1. The regulation of other employees in the prescription or pharmacy department, including but not limited to the registration and regulation of pharmacy technicians. The board shall be required to establish the minimum qualifications for the registration of pharmacy technicians and shall be authorized to require the completion of a background check and criminal history record check for each person applying for registration as a pharmacy technician in this state. The certificate of registration, once issued, may be valid for no more than two years and shall be renewable biennially upon payment of a renewal fee and compliance with such other conditions as the board may establish by rule or regulation. The board shall be authorized to deny registration, to deny renewal, or to revoke or suspend the registration of a pharmacy technician for any of the grounds set forth in Code Section 26-4-60 or Code Section 43-1-19. However, said denial of a technician application, denial of the renewal of a certificate, or suspension or revocation of a technician registration shall not be considered a contested case under Chapter 13 of Title 50, the "Georgia Administrative Procedure Act," but said applicant or registrant shall be entitled to an appearance before the board. The board shall be required to establish and maintain a registry of pharmacy technicians in this state which contains the name and home address of each pharmacy technician and his or her employer and location of employment. The board shall establish a process by which the pharmacist in charge of each pharmacy shall provide updated information on the pharmacy technicians in the pharmacy. The board may establish and collect fees from pharmacy technicians, their employers, or both for the registration of pharmacy technicians and maintenance of the registry.
      2. 1. In enforcing this paragraph, the board may, upon reasonable grounds, require a registrant or applicant to submit to a mental or physical examination by licensed health care providers designated by the board. The results of such examination shall be admissible in any hearing before the board, notwithstanding any claim of privilege under a contrary rule of law or statute, including, but not limited to, Code Section 24-9-21. Every person who shall accept the privilege of practicing as a pharmacy technician in this state or who shall file an application for a certificate of registration to practice pharmacy in this state shall be deemed to have given his or her consent to submit to such mental or physical examination and to have waived all objections to the admissibility of the results in any hearing before the board, upon the grounds that the same constitutes a privileged communication. If a registrant or applicant fails to submit to such an examination when properly directed to do so by the board, unless such failure was due to circumstances beyond his or her control, the board may enter a final order upon proper notice, hearing, and proof of such refusal. Any registrant or applicant who is prohibited from practicing as a pharmacy technician under this paragraph shall at reasonable intervals be afforded an opportunity to demonstrate to the board that he or she can resume or begin practicing as a pharmacy technician with reasonable skill and safety to patients.
         2. For the purposes of this paragraph, the board may, upon reasonable grounds, obtain any and all records relating to the mental or physical condition of a registrant or applicant, including psychiatric records; and such records shall be admissible in any hearing before the board, notwithstanding any claim of privilege under a contrary rule of law or statute, including, but not limited to, Code Section 24-9-21. Every person who shall accept the privilege of practicing as a pharmacy technician in this state or who shall file an application for a certificate of registration to practice as a pharmacy technician in this state shall be deemed to have given his or her consent to the board's obtaining any such records and to have waived all objections to the admissibility of such records in any hearing before the board, upon the grounds that the same constitutes a privileged communication.
         3. If any registrant or applicant could, in the absence of this paragraph, invoke a privilege to prevent the disclosure of the results of the examination provided for in division (i) of this subparagraph or the records relating to the mental or physical condition of such registrant or applicant obtained pursuant to division (ii) of this subparagraph, all such information shall be received by the board in camera and shall not be disclosed to the public, nor shall any part of the record containing such information be used against any registrant or applicant in any other type of proceeding;
   8. The collection of professional demographic data;
   9. The right to seize any such drugs and devices found by the board to constitute an imminent danger to the public health and welfare;
   10. The establishment of minimum specifications for the physical facilities, technical equipment, environment, supplies, personnel, and procedures for the storage, compounding, and dispensing of such drugs or devices utilized within the practice of pharmacy;
   11. The establishment of minimum standards for the purity and quality of such drugs utilized within the practice of pharmacy;
   12. The establishment of minimum standards for the purity and quality of such devices and other materials utilized within the practice of pharmacy;

       (12.1) (A) The licensure for the use of remote automated medication systems and the regulation and establishment of minimum standards for the use and operation of remote automated medication systems to ensure safe and efficient dispensing, including, but not limited to, appropriate security measures, requirements for skilled nursing facilities and hospices that utilize such systems, training requirements, accuracy and quality assurance measures, recordkeeping requirements, and such other appropriate requirements as determined by the board.

       1. The regulation and establishment of minimum standards for the use and operation of remote automated medication systems by the board as provided for in subparagraph (A) of this paragraph shall permit a pharmacy technician registered pursuant to this chapter to fill a remote automated medication system. If the remote automated medication system utilizes radio frequency identification or bar coding in the filling process, the pharmacy shall retain an electronic record of the filling activities of the pharmacy technician. If the remote automated medication system does not utilize radio frequency identification or bar coding in the filling process, a pharmacist shall supervise continuously the filling activities of the pharmacy technician through a two-way audiovisual system.
       2. The board may establish rules and regulations to implement the requirements of this paragraph;
   13. The issuance and renewal of licenses or permits of all persons engaged in the manufacture and distribution of drugs, including but not limited to all types of drug manufacturers, wholesale distributors, reverse drug distributors, outsourcing facilities, and third-party logistics providers. The board shall be authorized to establish all licensing and permit requirements of such entities by rule and regulation;
   14. The issuance and renewal of licenses of all persons engaged in the manufacture and distribution of devices utilized within the practice of pharmacy;

       (14.1) The issuance, suspension, denial, and renewal of licenses for suppliers of durable medical equipment pursuant to Code Section 26-4-51;

   15. The inspection of any licensed person at all reasonable hours for the purpose of determining if any provisions of the laws governing the legal distribution of drugs or devices or the practice of pharmacy are being violated. The board and its officers, agents, and designees shall cooperate with all agencies charged with the enforcement of the laws of the United States, of this state, and of all other states relating to drugs, devices, and the practice of pharmacy;
   16. The investigation of alleged violations of this chapter or any other law in this state pertaining to, or in connection with, persons or firms licensed by the board or otherwise authorized by the laws of this state to manufacture, sell, distribute, dispense, or possess drugs, medicines, poisons, cosmetics, or devices, as related to misbranded or counterfeit drugs, or any rules and regulations promulgated by the board under this chapter; the conducting of investigative interviews or full board hearings, with or without the necessity of utilizing the Office of State Administrative Hearings, in respect thereto when in its discretion it appears to be necessary; and the bringing of such violations to the notice of the Attorney General;
   17. The listing at any time upon either a list under Article 3 of Chapter 13 of Title 16, the "Dangerous Drug Act," or upon a schedule under Article 2 of Chapter 13 of Title 16, the "Georgia Controlled Substances Act," of any drug found to be potentially dangerous to public safety if dispensed without prescription;
   18. The expunging of the pharmacy related practice record of any pharmacist whose record consists of a sole sanction resulting from alcohol impairment and whose pharmacy related practice record during a five-year time period dating from the time of the sanction has incurred no additional charges or infractions;
   19. Restricting the inspection or examination of records or access to any area licensed and under the control of any registrant, which has been issued a permit by the board, to members of the board, agents for the Georgia Drugs and Narcotics Agency, the United States Drug Enforcement Administration, the Department of Community Health, or other federal agencies or agencies of this state otherwise entitled to such inspections or examinations by law, subpoena, or court order. This paragraph specifically prohibits inspections or examinations of board registrants or any requirement which forces board registrants to allow inspection or examination, or both, of their records by representatives for any nongovernment affiliated, private organization for any purpose since the access of patient prescription records is restricted by this chapter and access by such private organizations is unnecessary in that this access only duplicates existing record-keeping and inspection requirements already addressed by the laws and regulations of the board and other government organizations. This restriction shall also prohibit a private, nongovernment affiliated organization from examining or copying continuing education certificates maintained by individual registrants. Nothing in this paragraph shall prohibit the pharmacist in charge from voluntarily allowing appropriate agencies and organizations to inspect or examine the records and pharmacy area under the control of the pharmacist in charge provided such inspections or examinations are for the purposes of ensuring the quality of care provided to patients;
   20. The requiring of background checks, including, but not limited to, criminal history record checks, on any persons or firms applying for licensure or registration pursuant to this chapter;
   21. Serving as the sole governmental or other authority which shall have the authority to approve or recognize accreditation or certification programs for specialty pharmacy practice or to determine the acceptability of entities which may accredit pharmacies or certify pharmacists in a specialty of pharmacy practice, and the board may require such accreditation or certification as a prerequisite for specialty or advanced pharmacy practice. Such accreditation and certification standards for specialties shall be set forth in rules promulgated by the board with such rules to contain the required qualifications or limitations. Any accreditation or certification for specialty pharmacy practice approved or recognized by the board shall be deemed sufficient to meet any and all standards, licensure, or requirements, or any combination thereof, otherwise set forth by any private entity or other government agency to satisfy its stated goals and standards for such accreditation or certification. Nothing in this paragraph shall prohibit private entities, government agencies, professional organizations, or educational institutions from submitting accreditation or certification programs for the review and potential approval or recognition by the board. Accreditation and certification for specialty pharmacy practice under this paragraph shall be subject to the following conditions:
       1. Applications shall be submitted as set forth in rules promulgated or approved by the board for accreditation or certification;
       2. Only a pharmacist registered by this state and maintaining an active license in good standing is eligible for certification in a specialty pharmacy practice by the board;
       3. Only a pharmacy registered by this state and maintaining an active license in good standing is eligible for accreditation for specialty pharmacy practice by the board;
       4. Any board approved or recognized accreditation for a specialty pharmacy practice of a pharmacy is to be deemed sufficient and shall satisfy any standards or qualifications required for payment of services rendered as set forth by any insurance company, carrier, or similar third-party payor plan in any policy or contract issued, issued for delivery, delivered, or renewed on or after July 1, 1999;
       5. Any board approved or recognized specialty certification issued to a pharmacist is deemed sufficient and shall satisfy any standards or qualifications required for payment of services rendered as set forth by any insurance company, carrier, or similar third-party payor plan in any policy or contract issued, issued for delivery, delivered, or renewed on or after July 1, 1999; and
       6. The board may deny, revoke, limit, suspend, probate, or fail to renew the accreditation or specialty certification of a pharmacy, pharmacist, or both for cause as set forth in Code Section 26-4-60 or for a violation of Chapter 13 of Title 16 or if the board determines that a pharmacy, pharmacist, or both no longer meet the accreditation or certification requirements of the board. Before such action, the board shall serve upon the pharmacist in charge of a pharmacy or pharmacist an order to show cause why accreditation or certification should not be denied, revoked, limited, suspended, or probated or why the renewal should not be refused. The order to show cause shall contain a statement for the basis therefor and shall call upon the pharmacist in charge of a pharmacy, the pharmacist, or both to appear before the board at a time and place not more than 60 days after the date of the service of the order;
   22. To adopt a seal by which the board shall authenticate the acts of the board;
   23. To keep a docket of public proceedings, actions, and filings;
   24. To set its office hours;
   25. To require licensees and permit holders to report a change of business address or personal address within ten days of the change in either address;
   26. To adopt necessary rules concerning proceedings, hearings, review hearings, actions, filings, depositions, and motions related to uncontested cases;
   27. 1. To authorize the Georgia Drugs and Narcotics Agency to conduct inspections and initiate investigations on its behalf for the purpose of discovering violations of this chapter, Chapter 3 of this title, and Chapter 13 of Title 16.
       2. When conducting investigations and inspections on behalf of the board, the Georgia Drugs and Narcotics Agency shall have the same access to and may examine any relevant writing, document, or other material relating to any licensee, registrant, permittee, or applicant as the board. The executive director may issue subpoenas to compel access to any writing, document, or other material upon a determination that reasonable grounds exist for the belief that a violation of this chapter, Chapter 3 of this title, Chapter 13 of Title 16, or any other law relating to the practice of pharmacy may have taken place. The results of all investigations and inspections initiated by the Georgia Drugs and Narcotics Agency which relate to an individual licensed or permitted by the board shall be reported by the Georgia Drugs and Narcotics Agency to the board, and the records of such investigations shall be kept for the board by the director of the Georgia Drugs and Narcotics Agency, and the board shall retain the right to have access to such records at any time. Notwithstanding the provisions of this subparagraph, Code Section 16-13-60 shall control the access to or release of information.
       3. Nothing in this chapter shall be construed to prohibit or limit the authority of the executive director or the director of the Georgia Drugs and Narcotics Agency to conduct inspections and initiate investigations on its own initiative for the purpose of discovering violations of this chapter, Chapter 3 of this title, and Chapter 13 of Title 16 and disclose such information to any law enforcement agency or prosecuting attorney. Notwithstanding the provisions of this subparagraph, Code Section 16-13-60 shall control the access to or release of information.
       4. The executive director or the director of the Georgia Drugs and Narcotics Agency may also disclose to any person or entity information concerning the existence of any investigation for unlicensed practice being conducted against any person who is neither licensed nor an applicant for licensure by the board;
   28. To administer oaths, subpoena witnesses and documentary evidence, including relevant medical records, and take testimony in all matters relating to its duties;
   29. To conduct hearings, reviews, and other proceedings according to Chapter 13 of Title 50, the "Georgia Administrative Procedure Act";
   30. To have the cognizant member of the board conduct investigative interviews in conjunction with the Georgia Drugs and Narcotics Agency and thereafter to report his or her findings, with recommendations, to the board. In order to obtain a nonprejudicial decision, such report and recommendations shall not disclose the identity of the subject of the investigation. The cognizant member shall not vote on matters which he or she has presented to the board as the cognizant member;
   31. To issue cease and desist orders to stop the unlicensed practice of pharmacy or other professions licensed, certified, or permitted under this chapter and impose penalties for such violations;
   32. To refer cases for criminal prosecution or injunctive relief to appropriate prosecuting attorneys or other law enforcement authorities of this state, another state, or the United States;
   33. To release investigative or applicant files to another enforcement agency or lawful licensing authority in another state;
   34. To sue and be sued in a court of competent jurisdiction;
   35. To enter into contracts;
   36. To assess fines for violations of this chapter or board rules; and
   37. To set all reasonable fees by adoption of a schedule of fees approved by the board. The board shall set such fees sufficient to cover costs of operation.
2. Proceedings by the board in the exercise of its authority to cancel, suspend, or revoke any license issued under the terms of this chapter shall be conducted in accordance with Chapter 13 of Title 50, the "Georgia Administrative Procedure Act." In all such proceedings, the board shall have authority to compel the attendance of witnesses and the production of any book, writing, or document upon the issuance of a subpoena therefor signed by the secretary of the board. In any hearing in which the fitness of a licensee or applicant to practice pharmacy or another business or profession licensed by the board under this chapter is in question, the board may exclude all persons from its deliberation of the appropriate action to be taken and may, when it deems it necessary, speak to a licensee or applicant and his or her legal counsel in private.
3. The board shall have such other duties, powers, and authority as may be necessary to the enforcement of this chapter and to the enforcement of board rules made pursuant thereto which shall include, but are not limited to, the following:
   1. The board may join such professional organizations and associations organized exclusively to promote the improvement of the standards of the practice of pharmacy for the protection of the health and welfare of the public and whose activities assist and facilitate the work of the board;
   2. The board may place under seal all drugs or devices that are owned by or in the possession, custody, or control of a licensee at the time his or her license is suspended or revoked or at the time the board refuses to renew his or her license. Except as otherwise provided in this Code section, drugs or devices so sealed shall not be disposed of until appeal rights under Chapter 13 of Title 50, the "Georgia Administrative Procedure Act," have expired, or an appeal filed pursuant to such chapter has been determined. The court involved in an appeal filed pursuant to such chapter may order the board, during the pendency of the appeal, to sell sealed drugs that are perishable. The proceeds of such a sale shall be deposited with that court;
   3. Except as otherwise provided to the contrary, the board shall exercise all of its duties, powers, and authority in accordance with Chapter 13 of Title 50, the "Georgia Administrative Procedure Act";
   4. In addition to the fees specifically provided for in this chapter, the board may assess additional reasonable fees for services rendered to carry out its duties and responsibilities as required or authorized by this chapter or the rules and regulations promulgated by the board. Such services rendered shall include but not be limited to the following:
      1. Issuance of duplicate certificates or identification cards;
      2. Certification of documents;
      3. License transfer;
      4. Examination administration to a licensure applicant; and
      5. Examination materials; and
   5. Cost recovery.
      1. For any order issued in resolution of a disciplinary proceeding before the board, the board may direct any licensee found guilty of a charge involving a violation of any drug laws or rules to pay to the board a sum not to exceed the reasonable costs of the investigation and prosecution of the case and, in any case, not to exceed $25,000.00. The costs to be assessed shall be fixed by the board and the costs so recovered shall be paid to the state treasury; and
      2. In the case of a pharmacy or wholesale distributor, the order issued may be made to the corporate owner, if any, and to any pharmacist, officer, owner, or partner of the pharmacy or wholesale distributor who is found to have had knowledge of or have participated knowingly in one or more of the violations set forth in this Code section.

         Where an order for recovery of costs is made and timely payment is not made as directed in the board's decision, the board may enforce the order for payment in the court in the county where the administrative hearing was held. This right of enforcement shall be in addition to any other rights the board may have as to any person directed to pay costs. In any action for recovery of costs, proof of the board's decision shall be conclusive proof of the validity of the order of payment and the terms for payment.

(Code 1981, §26-4-28, enacted by Ga. L. 1998, p. 686, § 1; Ga. L. 1999, p. 81, § 26; Ga. L. 1999, p. 277, §§ 2, 3; Ga. L. 2007, p. 229, § 1/HB 330; Ga. L. 2011, p. 308, § 6/HB 457; Ga. L. 2011, p. 541, § 1/SB 81; Ga. L. 2012, p. 775, § 26/HB 942; Ga. L. 2013, p. 141, § 26/HB 79; Ga. L. 2013, p. 192, § 1-9/HB 132; Ga. L. 2015, p. 1360, § 1/HB 511; Ga. L. 2016, p. 855, § 2/HB 926; Ga. L. 2017, p. 614, § 2/SB 41; Ga. L. 2017, p. 774, § 26/HB 323.)

The 2012 amendment, effective May 1, 2012, part of an Act to revise, modernize, and correct the Code, revised punctuation at the end of paragraph (a)(12.1).

The 2013 amendments. The first 2013 amendment, effective April 24, 2013, part of an Act to revise, modernize, and correct the Code, substituted "the Department of Community Health" for "the Georgia Department of Medical Assistance" in the first sentence of paragraph (a)(19). The second 2013 amendment, effective July 1, 2013, deleted "and" from the end of paragraph (a)(20); substituted a semicolon for a period at the end in subparagraph (a)(21)(F); added paragraphs (a)(22) through (a)(37); and, in the last sentence of subsection (b), inserted "or another business or profession licensed by the board under this chapter" near the middle, and inserted "and his or her legal counsel in private" near the end.

The 2015 amendment, effective July 1, 2015, in paragraph (a)(12.1), added the subparagraph (A) and (C) designations and added subparagraph (a)(12.1)(B).

The 2016 amendment, effective July 1, 2016, substituted the present provisions of paragraph (a)(13) for the former provisions, which read: "The issuance and renewal of licenses of all persons engaged in the manufacture and distribution of drugs;".

The 2017 amendments. The first 2017 amendment, effective July 1, 2017, added paragraph (a)(14.1). The second 2017 amendment, effective May 9, 2017, part of an Act to revise, modernize, and correct the Code, revised punctuation in subsection (a) and substituted "Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act';" for "Chapter 13 of Title 50;" in paragraph (a)(29).