Georgia: Pharmacy Law Exam

II. GEORGIA DRUG AND NARCOTIC AGENCY: Duties and Responsibilities

1. Visit and inspect factories, warehouses, wholesaling establishments, retailing establishments, chemical laboratories, and such other establishments in which any drugs, devices, cosmetics, and such articles known as family remedies, grocer's drugs, and toilet articles are manufactured, processed, packaged, sold at wholesale, sold at retail, or otherwise held for introduction into commerce. 2. Enter and inspect any vehicle used to transport or hold any drugs, devices, and/or cosmetics. 3. Investigate alleged violations of laws and regulations regarding drugs, devices, and cosmetics by taking up samples of the articles (drugs, devices, and/or cosmetics) from any of the said establishments for examination and analysis by the state chemist, Code Section 26-4-131. 4. Seize and take possession of all articles which are declared to be contraband under Chapter 13 of Title 16 and Chapter 3 of this title and this chapter, and deliver such articles to the agency. 5. Compel the attendance of witnesses and the production of evidence on behalf of the board via a subpoena issued by the director, when there is reason to believe any violations of laws or regulations concerning drugs, devices, cosmetics, or any of the articles listed in paragraph (1) of this subsection have occurred. 6. Perform such other duties as may be directed by the board.

XI. IMPAIRED PROFESSIONALS

A. Whenever a pharmacist, intern or extern, becomes unfit to practice pharmacy with reasonable skill and safety by reason of a mental or physical condition including impairment due to the use of alcohol, narcotics, stimulants, or other habit-forming drugs.18 B. The board has the duty and authority to place appropriate conditions or limitations on that person's license, including suspension or revocation. C. Whenever such pharmacist, intern or extern, is impaired or has otherwise endangered the public health and welfare while engaged in the practice of pharmacy, and any other board licensee is aware of such impairment he/she has the obligation and duty to notify the board of such impaired persons and their actions.

Dentist DDS, DMD

Any drug necessary to the proper practice of dentistry.

Physician MD, DO

Any drug within the course of legitimate medical practice.

Podiatrist DPM

Any drug within the course of legitimate professional practice.

Veterinarian DVM

Any drug within the course of legitimate professional practice.

Manufacturer

"Manufacturer" means a person engaged in the manufacturing of drugs or devices.

III. PHARMACIST QUALIFICATIONS. Exemption from Licensure

. Practitioners authorized under the laws of this state to compound drugs and to dispense drugs to their patients in the practice of their respective professions shall not be required to be licensed under the provisions of this chapter.5 2. Exceptions for active duty service members:6 a. As used in this Code section, the term "service member" means an active duty member of the regular or reserve component of the United States Armed forces, the United States Coast Guard, the Georgia National Guard, or the Georgia Air National Guard who was on ordered federal duty for a period of 90 days or longer. b. Any service member whose license issued pursuant to this article expired while such service member was serving on active duty outside the state shall be permitted to practice pharmacy in accordance with such expired license and shall not be charged with a violation of this chapter related to practicing pharmacy with an expired license for a period of six months from the date of his or her discharge from active duty or reassignment to a location within the state. Any such service member shall be entitled to renew such expired license without penalty within six months aer the date of his or her discharge from active duty or reassignment to a location within the state. The service member must present to the board either a copy of the oicial military orders or a written verification signed by the service member's commanding oicer to waive any charges.

XVI. PRESCRIPTION RECORDS The pharmacist shall make a reasonable eort to obtain, record, and maintain the following information:

1. A list of all prescription drug orders obtained by the patient at the pharmacy where the prescription drug order is being filled for at least the preceding two years, showing the prescription number, the name and strength of the drug, the quantity and date dispensed, and the name of the prescribing practitioner. 2. Comments from the pharmacist relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug. 3. A patient record shall be maintained for a period of not less than two years from the date of the last entry in the profile record. This record may be a hard copy of a computerized form. 4. All dangerous drugs (legend drugs), controlled substances, or poisons shall be kept in the prescription department, and shall be kept from the public in a secure manner. Every retail pharmacy, possessing or having possessed any controlled substances and/or dangerous drugs, within a period of two years, and/or possessing any record related to the same, shall exercise diligent care in protecting such controlled substances and/or dangerous drugs and/or records related to the same from loss or the.

XXVI. GENERIC SUBSTITUTION: B. If a pharmacist substitutes a generic drug product for a brand name prescribed drug product when dispensing a prescribed medication, the brand name and the generic name of the drug product, with an explanation of "generic for (insert name of brand name prescribed drug product)" or similar language to indicate substitution has occurred, must appear on the prescription label and be aixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the drug may not appear upon the prescription label.

1. A patient for whom a prescription drug order is intended may instruct a pharmacist not to substitute a generic name drug in lieu of a brand name drug. 2. A practitioner of the healing arts may instruct the pharmacist not to substitute a generic name drug in lieu of a brand name drug by including the words "brand necessary" in the body of the prescription. a. When a prescription is a hard copy prescription drug order, such indication of brand necessary must be in the practitioner's own handwriting and shall not be printed, applied by rubber stamp, or any such similar means. b. When the prescription is an electronic prescription drug order, the words "brand necessary" are not required to be in the practitioner's own handwriting and may be included on the prescription in any manner or by any method. When a practitioner has designated "brand necessary" on an electronic prescription drug order, a generic drug shall not be substituted without the practitioner's express consent.

XXIII. PHYSICAL FACILITY AND EQUIPMENT OF A COMMUNITY PHARMACY:. Hours of Operation

1. A prescription department open for business at all times that the business establishment is open to the public, except that during temporary absences of any licensed pharmacist not to exceed three hours daily or more than one and one-half hours at any one time the prescription department shall be closed and no prescription shall be filled or dispensed. 2. During hours of operation, every pharmacy licensed pursuant to this chapter shall have a prescription department under the personal supervision of a duly licensed pharmacist who shall have personal supervision of not more than one pharmacy at the same time.

XXI. NURSING HOME AND LONG-TERM CARE FACILITIES: Emergency Drug Kits

1. A record of the drugs to be kept in an emergency drug kit to be kept in the hospice and the provider pharmacy. 2. Drugs shall not be accessed for use from the emergency drug kit in an emergency situation without a new prescription drug order from a licensed practitioner. A valid, signed prescription drug order for any such drug must be issued to the vendor pharmacy, supplying the emergency drug kit, within 72 hours of the drug being taken from the kit. 3. Emergency drug kits shall be stored in limited access areas and sealed to prevent unauthorized access and to ensure a proper environment for preservation of the drugs therein. The provider pharmacy shall develop a method to readily determine if an emergency drug kit has been accessed without authorization. 4. An emergency drug kit must be inventoried once a month by a pharmacist from the provider pharmacy and sign a card attached to the kit indicating the date it was inspected. The provider pharmacy must maintain an adequate record of such inspections.

XXII. NUCLEAR PHARMACY:A. An applicant for a license as a nuclear pharmacist shall:

1. A record of the drugs to be kept in an emergency drug kit to be kept in the hospice and the provider pharmacy. 2. Drugs shall not be accessed for use from the emergency drug kit in an emergency situation without a new prescription drug order from a licensed practitioner. A valid, signed prescription drug order for any such drug must be issued to the vendor pharmacy, supplying the emergency drug kit, within 72 hours of the drug being taken from the kit. 3. Emergency drug kits shall be stored in limited access areas and sealed to prevent unauthorized access and to ensure a proper environment for preservation of the drugs therein. The provider pharmacy shall develop a method to readily determine if an emergency drug kit has been accessed without authorization. 4. An emergency drug kit must be inventoried once a month by a pharmacist from the provider pharmacy and sign a card attached to the kit indicating the date it was inspected. The provider pharmacy must maintain an adequate record of such inspections.

"Intern" or "pharmacy intern

1. A student who is currently enrolled in an approved school or college of pharmacy, has registered with the board, and has been licensed as a pharmacy intern 2. A graduate of an approved school or college of pharmacy who is currently licensed by the board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist

III. PHARMACIST QUALIFICATIONS: Reciprocal Licensure Requirements

1. Licensees from another state may apply for license transfer provided they have possessed at the time of initial licensure as a pharmacist, all qualifications necessary to have been eligible for licensure at that time in this state. 2. Applicant must present to the board proof of initial licensure by examination and proof that such license is in good standing. 3. Applicant must present to the board proof that any other license granted to the applicant by any other state is not currently suspended, revoked, or otherwise restricted for any reason except nonrenewal or for the failure to obtain the required continuing education credits in any state where the applicant is currently licensed, but not engaged in the practice of pharmacy. 4. Applicant must successfully passed a jurisprudence examination approved by the Board on Georgia's pharmacy laws and Board regulations, and have successfully passed the Georgia practical exam approved by the Board. 5. If requested by the board, applicant must personally appeared for an interview with a member of the board. 6. Applicant must pay the fees specified by the board.

I. STATE BOARD OF PHARMACY:Composition The board shall consist of 8 members.

1. Seven members must be pharmacists. At the time of appointment the pharmacists must be residents of GA for at least six months, hold current licensure in GA and be in good standing, be actively engaged in the practice in GA, have 5 years of practice experience in GA, not be oicially employed as a full-time faculty member by any school/college of pharmacy. 2. One member is a nonpharmacist (consumer). 3. All appointments to the board are made by the governor. 4. Pharmacist members shall represent a diversity of practice settings and geographic dispersion of practitioners across the state. 5. The Board may appoint an Executive Director who shall serve at the pleasure of the Board. a. In absence of the Executive Director, the Director of the Georgia Drugs and Narcotic Agency shall serve as the Assistant Executive Director and shall have all the powers of the Executive Director

II. GEORGIA DRUG AND NARCOTIC AGENCY:Classifications and Requirements2

1. The agency was created in 1908 as the Oice of the Chief Drug Inspector. 2. Now known as the Georgia Drugs and Narcotics Agency since 1976. 3. The Georgia Drugs and Narcotics Agency is authorized by this Code section to enforce the drug laws of this state. 4. The board of pharmacy shall appoint a director who shall be charged with supervision and control of such agency. 5. The agency shall employ the number of personnel deemed necessary to properly protect the health, safety, and welfare of the citizens of this state. a. Such personnel shall be pharmacists registered in this state when employed as either special agents or the deputy director. 6. The director shall hold oice at the pleasure of the board, and should any vacancy occur in said oice for any cause whatsoever, said board shall appoint a successor at a regular or called meeting. a. The director shall be a pharmacist registered in this state.

XV. PRESCRIPTION LABELS OF CONTROLLED SUBSTANCES:B. Each individual, customized, multidrug single-dosing container shall bear a label, which at a minimum, contains the following:

1. The name of the patient 2. The name of the prescribing practitioner of each drug 3. The name, address, and telephone number of the pharmacy issuing the multidrug single-dosing container 4. The identifying serial number assigned to the prescription drug order for each drug contained therein 5. The name, strength, physical description, and total quantity of each drug contained therein 6. The directions for use and/or time of administration or time to be taken for each individual multidrug single-dosing container 7. Either the dispensing or preparation date, as well as a beyond-use expiration date for each drug contained in the multidrug single-dosing container, the expiration date of each drug included therein shall not be longer than one (1) year from the date of preparation of the multidrug single-dosing container 8. Cautionary statements, if any, as required

XV. PRESCRIPTION LABELS OF CONTROLLED SUBSTANCES A. A pharmacist filling a prescription drug order for a C-II, III, IV, or V substance shall aix to the package a label showing the following:

1. The name, address, and telephone number of the pharmacy 2. The prescription drug order serial number 3. The date the prescription was initially filled or refilled 4. The name of the patient 5. The name of the prescribing practitioner 6. The directions for use 7. The expiration date of the dispensed drug

Pharmacy

1. The profession, art, and science that deals with pharmacy care, drugs, or both, medicines, and medications, their nature, preparation, administration, dispensing, or eect. 2. Any place licensed in accordance with this chapter wherein the possessing, displaying, compounding, dispensing, or selling of drugs may be conducted, including any and all portions of the building or structure leased, used, or controlled by the licensee in the conduct of the business or profession licensed by the board at the address for which the license was issued.

Nurse Practitioner (NP) APRN

General authority to prescribe is evident by inclusion on the prescription of the prescriber's title and as outlined in the prescriber's collaborative practice agreement and/or nurse protocol agreement within a specialty area. Authority to prescribe controlled substances is limited to only Schedule III-V, using his/her own DEA number. Controlled prescriptions written from NP cannot be filled out of state.

Remote prescription drug order processing

Shall mean the processing of prescription or patient information from a location other than the location from which the prescription medication is received and dispensed. It shall not include the dispensing of a drug, but may include: 1. Receiving the prescription order from the primary dispensing pharmacy; 2. Interpreting, analyzing, or clarifying prescriptions; 3. Entering prescription or patient data into a data processing system; 4. Transferring prescription information; 5. Performing a drug regimen review; 6. Performing a drug allergy review; 7. Performing therapeutic interventions; or 8. Any combination of these order processing functions.

I. STATE BOARD OF PHARMACY:Term

The term of office for each board member is five years or until their successors are appointed and qualified.

III. PHARMACIST QUALIFICATIONS: Eligibility

To be eligible for licensure as a pharmacist, applicants must: 1. Have submitted an application in the form prescribed by the board; 2. Have attained the age of majority; 3. Be of good moral character; 4. Have graduated and received a professional undergraduate degree from a college or school of pharmacy as the same may be approved by the board, provided, however, that, since it would be impractical for the board to evaluate a school or college of pharmacy located in another country, the board may accept a graduate from such a school or college so long as the graduate has completed all requirements of the Foreign Pharmacy Equivalency Certification Program administered by the National Association of Boards of Pharmacy. This shall include successful completion of all required examinations and the issuance of the equivalency certificate and be based upon an individual evaluation by the board of the applicant's educational experience, professional background, and proficiency in the English language; 5. Have completed an internship or other program that has been approved by the board; 6. Pass the pharmacist licensure examination (NAPLEX)®, the jurisprudence examination (MPJE) approved by the Board, and the Georgia practical examination approved by the Board, with a minimum score of 75; a. The examination for licensure shall be made available at least two times during each year. b. Any person who takes the board-approved examination and fails the examination may repeat the examination at regular intervals of administration; however, a person shall not take the examination more than three times without permission from the board. A person who has taken the board-approved examination and failed the examination for the third time shall not practice as a pharmacy intern. A person who takes the board-approved examination and successfully completes the examination must become licensed within two years of the examination date or the results of the examination shall become invalid. 7. Pay the required fees specified by the board for the examination and any related materials and have paid for the issuance of the license.

Prescription drug order"

a lawful order of a practitioner for a drug or device for a specific patient; such order includes an electronic visual image prescription drug order and an electronic data prescription drug order.

"Pharmacist in charge"

a pharmacist currently licensed in this state who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs and who is personally in full and actual charge of such pharmacy and personnel.

XXI. NURSING HOME AND LONG-TERM CARE FACILITIES:Consultant Pharmacist

a pharmacist licensed to engage in the practice of pharmacy in this state who is responsible for developing, coordinating, and supervising pharmaceutical services in the nursing facility. These services shall include, at a minimum, review of each patient's drug regimen monthly and report of any irregularities to the medical director and administrator of the nursing facility, written reports of pharmaceutical services, and monitoring of established policies and procedures for medication handling and storage.

XXI. NURSING HOME AND LONG-TERM CARE FACILITIES: Vendor Pharmacist.

a pharmacist licensed to engage in the practice of pharmacy in this state who is responsible for supervising the proper dispensing and delivery of drugs to a nursing facility. These services shall include, at a minimum, proper drug labeling, storage, transport, and record keeping in compliance with all federal, state, and local laws and regulations. 1. The vendor pharmacist shall establish standards to ensure that all drugs are stored in a manner suicient to ensure the proper sanitation, temperature, light, ventilation, moisture control, segregation, and security.

Prospective drug use review

a review of the patient's drug therapy and prescription drug order, as defined in the rules of the board, prior to dispensing the drug as part of a drug regimen review.

XIII. COPIES OF PRESCRIPTION ORDERS A. Only a licensed pharmacist or a licensed pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, may prepare, receive, read, or transfer a copy of a prescription drug order to any person, and then only to a licensed pharmacist or licensed pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, who is authorized to receive and give such information as follows: 2. When a prescription drug order copy is sent and handled manually, meaning without the use of a computer or other electronic means, the person giving such copy shall record immediately upon his or her hard copy prescription drug order the following information:

a. That a copy of the prescription has been given and the prescription drug order is null and void, with the word "VOID" being marked on its face b. The name of the pharmacy, and telephone number, where the prescription drug order was transferred c. The name of the pharmacist, or pharmacy intern/extern who received the transferred prescription drug order information d. The date on which the prescription drug order was transferred

. "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.

Practitioner" or "practitioner of the healing arts

means a physician, dentist, podiatrist, or veterinarian and shall include any other person licensed under the laws of this state to use, mix, prepare, dispense, prescribe, and administer drugs in connection with medical treatment to the extent provided by the laws of this state.

"Security paper

means a prescription pad or paper that has been approved by the board for use and contains the following characteristics: 1. One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form; 2. One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription form by the practitioner; and 3. One or more industry-recognized features designed to prevent the use of counterfeit prescription forms. 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.

Electronic data signature"

means a secure, personalized digital key, code, number, or other identifier used for secure electronic data transmissions, which identifies and authenticates the prescribing practitioner as a part of an electronic data prescription drug order transmitted to a pharmacy.

"Electronic signature"

means an electronic visual image signature or an electronic data signature of a practitioner, which appears on an electronic prescription drug order.

"Pharmacist

means an individual currently licensed by this state to engage in the practice of pharmacy. This recognizes a pharmacist as a learned professional who is authorized to provide patient services and pharmacy care.

"Extern" or "pharmacy extern"

means an individual who is a student currently enrolled in an approved school or college of pharmacy and who has been assigned by the school or college of pharmacy to a licensed pharmacy for the purposes of obtaining practical experience and completing a degree in pharmacy. For the purposes of this chapter, a pharmacy extern may engage in any activity or perform any function which a pharmacy intern may perform under the direct supervision of a licensed pharmacist.

Preceptor

means an individual who is currently licensed as a pharmacist by the board, meets the qualifications as a preceptor under the rules of the board, and participates in the instructional training of pharmacy interns.

Device

means an instrument, apparatus, contrivance, or other similar or related article, including any component part or accessory, which is required under federal law to bear the label, "Caution: federal or state law requires dispensing by or on the order of a physician."

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. 1. 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.

"Dangerous drug

means any drug, substance, medicine, or medication as defined in Code Section 16-13-71.

Institution

means any licensed hospital, nursing home, assisted living community, personal care home, hospice, health clinic, or prison clinic.

"Wholesale distributor

means any person engaged in wholesale distribution of drugs, including, but not limited to, manufacturers; repackagers; own label distributors; private label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail and hospital pharmacies that conduct wholesale distributions.

"Confidential information

means information maintained by the pharmacist in the patient's records or which is communicated to the patient as part of patient counseling which is privileged and may be released only to the patient or, as the patient directs, to those practitioners and other pharmacists where, in the pharmacist's professional judgment, such release is necessary to protect the patient's health and well-being; and to such other persons or governmental agencies authorized by law to receive such confidential information.

"Emergency service provider

means licensed ambulance services, first responder services or neonatal services, or any combination thereof.

"Federal act" or "Federal Food, Drug, and Cosmetic Act

means the Federal Food, Drug, and Cosmetic Act of the United States of America, approved June 25, 1938.

"Board of Pharmacy" or "board"

means the Georgia State Board of Pharmacy.

"Deliver" or "delivery"

means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for a consideration.

Distribute

means the delivery of a drug or device other than by administering or dispensing.

"Dispense" or "dispensing"

means the preparation and delivery of a drug or device to a patient, patient's caregiver, or patient's agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.

"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.

Manufacturing

means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis and includes any packaging or repackaging of any substance or labeling or relabeling of its container and the promotion and marketing of such drugs or devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons.

"Brand name drug"

means the proprietary, specialty, or trade name used by a drug manufacturer for a generic drug and placed upon the drug, its container, label, or wrapping at the time of packaging.

"Administer" or "administration"

means the provision of a unit dose of medication to an individual patient as a result of the order of an authorized practitioner of the healing arts.

Substitution

means to dispense pharmaceutically equivalent and therapeutically equivalent drug products as regulated by the board in place of the drug prescribed.

Drug regimen review

ncludes, but is not limited to, the following activities: 1. Evaluation of any prescription drug order and patient record for: a. Known allergies b. Rational therapy contraindications c. Reasonable dose and route of administration d. Reasonable directions for use 2. Evaluation of any prescription drug order and patient record for duplication of therapy 3. Evaluation of any prescription drug order and patient record for the following interactions: a. Drug-drug; b. Drug-food; c. Drug-disease; d. Adverse drug reactions; and e. Evaluation of any prescription drug order and patient record for proper utilization, including overutilization or underutilization, and optimum therapeutic outcomes.

XXII. NUCLEAR PHARMACY:Requirements include

nuclear pharmacy operators permit, separate entity, maintain quality, maintain records; comply with laws; make authorized dispensing; transfer; label; redistribute.31 1. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals shall be under the supervision of a licensed nuclear pharmacist. All acts of compounding and dispensing radiopharmaceuticals shall be performed by the nuclear pharmacist or by a pharmacist or pharmacy intern under the direct supervision and control of a nuclear pharmacist. A nuclear pharmacist shall be responsible for all operations of the nuclear pharmacy and shall be in personal attendance at all times when the acts of compounding and dispensing are performed and the pharmacy is open for business. 2. Nuclear pharmacies shall have adequate space; it shall meet minimal space requirements established for all pharmacies in the state. The nuclear pharmacy area shall be separate from the pharmacy areas for nonradiopharmaceuticals and shall be secured from unauthorized personnel. 3. Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with acceptable professional standards of radiopharmaceutical quality assurance. 4. Nuclear pharmacies shall maintain records of acquisition and disposition of all radiopharmaceuticals in accordance with requirements of the board and the department. 5. Radiopharmaceuticals are to be dispensed only upon prescription order by a physician who is authorized by the department to possess, use, and administer radioactive materials. 6. In addition to any labeling requirements required by rules and regulations of the board for nonradiopharmaceuticals, the immediate outer container of a radiopharmaceutical to be dispensed shall also be labeled as required in rules and regulations of the board and of the department. 7. Nuclear pharmacies may redistribute federal FDA-approved radiopharmaceuticals if the pharmacy does not process the radiopharmaceuticals in any manner or violate the product packaging. Such redistribution may only be made to another nuclear pharmacy or other authorized person or institution.

"Division director"

the division director of the professional licensing boards division.

"Patient counseling

the oral communication by the pharmacist of information, as defined in the rules of the board, to the patient, patient's caregiver, or patient's agent, in order to improve therapy by ensuring proper use of drugs and devices.

XVII. PATIENT COUNSELING: A pharmacist shall not be required to counsel a patient or the caregiver of the patient when______

the patient or the caregiver of the patient refuses such consultation or counseling.

"Pharmacy care"

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.

"Pharmacy technician

those support persons utilized in pharmacies whose responsibilities are to provide nonjudgmental technical services concerned with the preparation for dispensing of drugs under the direct supervision and responsibility of a pharmacist.

XXIV. HOSPITAL PHARMACY:A. Hospital physical requirements

1. Area. A hospital pharmacy shall have within the hospital which it serves, suicient floor space allocated to it to ensure that drugs are prepared in sanitary, well-lighted, and enclosed places, and which meet the other requirements of this section and the Georgia Pharmacy Laws. The hospital pharmacy space requirements should be a minimum of 10 sq. . per hospital bed, which includes all areas assigned and under the direct control of the Director of Pharmacy. 2. Equipment and supplies. Each hospital pharmacy shall have suicient equipment and physical facilities for proper compounding, dispensing, and storage of drugs, including parenteral preparations. The equipment and physical facilities shall include the following: a. Compounding and dispensing area: i. A refrigerator in operating condition with a thermometer, preferably a biological refrigerator ii. A sink in operating condition with hot and cold running water iii. A Class A Balance and an assortment of metric weights if utilizing a Class A Balance or a Class I or II Electronic Balance as approved in writing by the Board iv. Graduates of assorted sizes v. Mortar and pestle vi. Two (2) spatulas and a counting tray vii. Typewriter, word processor, or computer with a label printer viii. Pill tile ix. Other equipment as deemed necessary by the Director of Pharmacy b. Parenteral solution additives area as required in: i. Laminar flow hood ii. Facility for light-dark field examination c. Storage and receiving area d. Manufacturing and packaging area e. Oice space area

Drug

1. Articles recognized as drugs in any oicial compendium, or supplement hereto, designated from time to time by the board for use in the diagnosis cure, mitigation, treatment, or prevention of disease in humans or animals; 2. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals; 3. Articles, other than food, intended to aect the structure or any function of the body of humans or animals; 4. Articles intended for use as a component of any articles specified in subparagraph; and 5. (1), (2), or (3) of this paragraph but does not include devices.

XX. COMPOUNDING Rule

1. 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 commercially or not commercially available in the marketplace. 2. Pharmacists shall receive, store, or use drugs that have been made in an FDA-approved facility. Pharmacists shall also receive, store, or use drugs in compounding prescriptions that meet oicial compendia requirements. If neither of these requirements can be met, pharmacists shall use their professional judgment to procure alternatives. 3. Pharmacists may compound drugs 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. The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing which requires a manufacturer's license. 4. The distribution of inordinate amounts of compounded preparations without a prescriber/patient/pharmacist relationship is considered manufacturing. 5. Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order, pharmacists may compound, in reasonable quantities, drug products that are commercially or not commercially available in the marketplace. 6. Pharmacists shall not oer compounded drugs to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a prescriber to administer to an individual patient. 7. Pharmacists engaged in the compounding of drugs shall operate in conformance with applicable state laws and rules regulating the practice of pharmacy. 8. If low-, medium-, and/or high-risk sterile preparations are being compounded, they must be in accordance with USP 797 and/or Georgia regulations. 9. If radiopharmaceuticals are being compounded, conditions set forth in the board's rules for nuclear pharmacists and pharmacies must be followed. 10. 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. 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. 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.

XIX. ELECTRONIC ORDERS:A. Electronic prescription drug orders shall either be an electronic visual image of a prescription drug order or an electronic data prescription drug.26 Prescriptions transmitted either electronically or via facsimile shall meet the following requirements:

1. Electronically transmitted prescription drug orders shall be transmitted by the practitioner, to the pharmacy of the patient's choice with no intervening person or intermediary having access to the prescription drug order. 2. Prescription drug orders transmitted by facsimile or computer shall include: a. In the case of a prescription drug order for a dangerous drug, the complete name and address of the practitioner; b. In the case of a prescription drug order for a controlled substance, the complete name, address, and DEA registration number of the practitioner; c. The telephone number of the practitioner for verbal confirmation; d. The name and address of the patient; e. The time and date of the transmission; f. The full name of the person transmitting the order; and g. The signature of the practitioner in a manner as defined in regulations. 3. An electronically transmitted, issued, or produced prescription drug order which meets the requirements of this Code section shall be deemed the original order. 4. The pharmacist shall exercise professional judgment regarding the accuracy and authenticity of any electronically transmitted, issued, or produced prescription drug order consistent with federal and state laws and rules and regulations adopted pursuant to the same. 5. An electronically encrypted, issued, or produced prescription drug order transmitted from a practitioner to a pharmacist shall be considered a highly confidential transaction. 6. Any pharmacist that transmits, receives, or maintains any prescription or prescription refill either orally, in writing, or electronically shall ensure the security, integrity, and confidentiality of the prescription and any information contained therein.

XXIV. HOSPITAL PHARMACY: Emergency Crash/Kits

1. Emergency Kits/Crash Carts. Drugs may also be provided for use by authorized personnel by emergency kits/crash carts, provided such kits/carts meet the following requirements: a. Emergency kit/crash cart drugs defined. Emergency kit/crash cart drugs are those drugs which may be required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in suicient time to prevent risk of harm to b. Drugs included. The Director of Pharmacy and the medical sta of the hospital shall jointly determine the drugs, by identity and quantity, to be included in the emergency kits/crash carts; c. Storage. Emergency kits/crash carts shall be sealed and stored in limited access areas to prevent unauthorized access, and to ensure a proper environment for preservation of the drugs within them; d. Labeling—exterior. The exterior of emergency kits/crash carts shall be labeled so as to clearly and unmistakably indicate that it is an emergency drug kit/crash cart and is for use in emergencies only. In addition, a listing of the drugs contained therein, including name, strength, quantity, and expiration date of the contents, shall be attached. Nothing in this section shall prohibit another method of accomplishing the intent of this section, provided such method is approved by an agent of the board; e. Labeling—interior. All drugs contained in emergency kits/ crash carts shall be labeled in accordance with such state and federal laws and regulations which pertain thereto, and shall also be labeled with such other and further information as may be required by the medical sta of the hospital to prevent misunderstanding or risk of harm to the patients; f. Removal of drugs. Drugs shall be removed from emergency kits/crash carts only pursuant to a valid practitioner's order, by authorized personnel, or by a pharmacist of the institutional facility; g. Notification. Whenever an emergency kit/crash cart is opened, the pharmacy shall be notified, and pharmacy personnel shall restock and reseal the kit/cart within a reasonable time so as to prevent risk of harm to patients. In the event the kit/cart is opened in an unauthorized manner, the pharmacy and other appropriate personnel of the facility shall be notified; and h. Inspections. Each emergency kit/crash cart shall be opened and its contents inspected by a pharmacist at least once every ninety (90) days. Upon completion of inspection, the emergency kit/crash cart shall be resealed.

IV. RENEWAL OF PHARMACIST LICENSURE

A. A pharmacist license is valid for 2 years.7 (Renewal of his or her license is done biennially.) B. All licenses expire on December 31 of even-numbered years. (Renewal must be submitted by December 31 of even-numbered year.) C. Pharmacists must complete thirty (30) hours of approved continuing education within the two years preceding license renewal. D. Notice of any change of employment or change of business address shall be filed with the division director within ten days aer such change. E. If a pharmacist fails to make application to the board for renewal of his or her license as set forth in and in accordance with the provisions of this chapter, the pharmacist must apply for reinstatement pursuant to the rules of the board.

XXVIII. PHARMACIST ADMINISTRATION OF IMMUNIZATIONS/VACCINATIONS

A. A physician engaged in the active practice of medicine may prescribe influenza vaccine for a group of patients via an influenza vaccine order contained in an influenza vaccine protocol agreement to be administered by a pharmacist.43 1. Provided the physician is registered with the vaccination registry established by the Department of Human Resources pursuant to Code Section 31-12-3.1, commonly known as the Georgia Registry of Immunization Transactions and Services. 2. The pharmacist is located within the county of the physician's place of registration with the vaccination registry or a county contiguous thereto, and the pharmacist holds current certification in Basic Cardiac Life Support and has completed a course of training accredited by the Accreditation Council for Pharmacy Education or similar health authority or professional body approved by the Georgia State Board of Pharmacy. B. Protocol agreements must contain a provision for immediate consultation between the pharmacist or nurse and the physician. If the physician is not available, the physician for purposes of consultation may designate another physician who concurs with the terms of the influenza vaccine protocol agreement. C. Require the pharmacist or nurse to provide the influenza vaccine recipient with the appropriate and current Vaccine Information Statement (VIS) as provided by the federal Centers for Disease Control and Prevention. D. Require the pharmacist or nurse or his or her employer to retain documentation of each dose of influenza vaccine administered. Such documentation shall include, but not be limited to: 1. The administering pharmacist's or nurse's name, address, telephone number, and professional license number 2. The name, dose, manufacturer, and lot number of the influenza vaccine 3. The vaccine recipient's name, address, date of birth, and telephone number 4. The date of administration and injection site 5. A signed and dated consent form by which the vaccine recipient acknowledges receipt of the VIS and consents to the administration of the influenza vaccine 6. Any adverse events or complications that occur E. Require the pharmacist or nurse to enter the patient's influenza vaccine information in the Georgia Registry of Immunization Transactions and Services within the registry's designated time frame, or as designated by the Department of Human Resources. F. Require, as a condition of administration of the influenza vaccine, the influenza vaccine recipient to remain under the observation of the administering pharmacist or nurse for a period of not less than 15 minutes immediately subsequent to the administration of the influenza vaccine. G. Contain procedures to follow up on the occurrence of an adverse event or complication including, if prescribed via an influenza vaccine order contained in an influenza vaccine protocol agreement, the administration of epinephrine. H. Provide for prioritization of influenza vaccine recipients in the event the supply of influenza vaccine is limited. I. Be renewed and, if necessary, revised or updated biennially by the physician and the pharmacist or nurse. An influenza vaccine protocol agreement that is not renewed biennially shall expire. J. It shall be unlawful for a physician who is employed by a pharmacist or nurse to enter into an influenza vaccine protocol agreement or otherwise delegate medical acts to such pharmacist or nurse. It shall be unlawful for a physician who is employed by a pharmacy to enter into an influenza vaccine protocol agreement or otherwise delegate medical acts to a pharmacist or nurse who is also employed by such pharmacy. K. No influenza vaccine protocol agreement entered into pursuant to this Code section shall permit a pharmacist or nurse to administer an influenza vaccine to any child under the age of 13 without an individual prescription from a physician, and consent of the child's parent or legal guardian.

XXIII. PHYSICAL FACILITY AND EQUIPMENT OF A COMMUNITY PHARMACY: A. Space and Equipment

1. Every pharmacy licensed under this chapter shall have a prescription department, which shall be kept clean and free of all materials not currently in use in the practice of compounding or preparing a medication for dispensing. 2. The space behind the prescription counter shall be kept free of obstruction at all times. 3. There shall be provided within the prescription department of each pharmacy suicient shelf, drawer, counter, or cabinet space for the neat and orderly storage of all drugs, equipment, publications, and other items kept therein. In addition, there shall be such clear floor space within each prescription department as to permit pharmacists, interns/externs, and/or technicians employed therein, to adequately, safely, and accurately fulfill their duties, related to prescriptions and drugs.34 4. The minimum floor space of a retail pharmacy shall be 150 sq. .34 5. There shall be provided within each prescription department adequate facilities for the proper storage of drugs or devices which require refrigeration.35 6. All pharmacies shall possess the following items:36 a. Copies of and/or computer or electronic access to current reference materials appropriate to the individual pharmacy practice. b. The telephone number of a poison control center. This number shall be conspicuously posted within the prescription department. c. Current copies of and/or computer or electronic access to the following: i. Georgia Pharmacy Practice Act ii. Georgia Controlled Substances Act & Dangerous Drug Act iii. Oicial Rules of the Georgia State Board of Pharmacy d. Equipment (appliances): i. Refrigerator in operating condition with a thermometer. ii. Sink in working condition with both hot and cold running water. e. Weighing and labeling: i. Class A Balance, Class I or II Electronic Balance ii. Assortment of weights: metric and apothecary iii. Appropriate prescription labels consistent with the requirements of the Georgia Drug and Cosmetic Act iv. Appropriate auxiliary labels that should be used in the pharmacist's professional judgment f. Other equipment: i. Graduates of assorted sizes; ii. Two mortars and pestles of assorted sizes; iii. Two spatulas; iv. One pill counting tray; v. Ointment slab, tile, or ointment paper pad; vi. Stirring rods; vii. Typewriter, word processor, or computer with label-printer; and viii. Any other equipment necessary for a specialized practice setting where such a specialized practice takes place. 7. If a pharmacy is located in a general merchandising establishment, or if the owner of the pharmacy so chooses, a portion of the space of the business establishment may be set aside and permanently enclosed or otherwise secured. Only that permanently enclosed or otherwise secured area shall be subject to the provisions of this chapter and shall be registered as a pharmacy.

V. INTERN QUALIFICATIONS:A. To obtain a license as a pharmacy intern, an applicant must:

1. Have submitted an application in the form prescribed by the board of pharmacy; 2. Have attained the age of majority; 3. Be of good moral character; 4. Have paid the fees specified by the board for the issuance of the license; 5. Be a student who is currently enrolled in an approved school or college of pharmacy; 6. Be an individual who is a graduate of an approved school or college of pharmacy who is currently licensed by the board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; and 7. Be an individual who does not meet the requirements of paragraphs (5) and (6) of this subsection and is a graduate of a pharmacy school or college located in another country, but who has completed all requirements of the Foreign Pharmacy Equivalency Certification Program administered by the National Association of Boards of Pharmacy. This shall include without being limited to successful completion of all required examinations, the issuance of the equivalency certificate, and an individual evaluation by the board of the applicant's proficiency in the English language.

XVIII. TRANSFERS OF CONTROLLED SUBSTANCES A. The transfer of original prescription drug order information for a C-III, IV, or V substance for the purpose of refill dispensing is permissible between pharmacies one time only

1. However, pharmacies electronically sharing a real-time, online computerized database may transfer the prescription drug order information as many times as there are authorized refills, up to the maximum of five (5) times, if it is within six (6) months from the date of issuance. A transfer is considered a communication between two licensed pharmacists and/or pharmacy interns/externs. Transfers are subject to the following requirements: a. The transferring pharmacist or pharmacy intern/extern shall record the following information in either real time or at the first opportunity aer the transfer: The word "VOID" must be written on the face of the original, hard copy, invalidated prescription drug 2. The following must be written on the back of the original, invalidated prescription drug order: the name, address, telephone number, and DEA number of the pharmacy to which it is transferred, and the name of the pharmacist receiving the prescription information. 3. The date of the transfer and the name of the pharmacist transferring the information must be recorded on the back of the prescription drug order. 4. The pharmacist or pharmacy intern/extern receiving the transferred prescription drug order information shall reduce it to writing and record the following information: a. The word "TRANSFER" shall be written on the face of the transferred prescription drug order hard copy. b. All information required to be recorded on a prescription drug order pursuant to this chapter, which shall include: i. Date the prescription drug order was originally issued by the prescribing practitioner ii. The number of refills authorized on the original prescription drug order c. Date the prescription drug order was originally dispensed by the transferring pharmacy. d. Number of valid refills remaining, and date(s) and pharmacy location(s) where any previous refills were dispensed. e. The pharmacy's name, address, telephone number, DEA number, and prescription serial number from which the prescription information was transferred. f. The name of the pharmacist who transferred the prescription drug order. 5. The original and transferred prescription(s) must be maintained for a period of 30 months from the date of the last refill. 6. Pharmacies electronically transferring a prescription drug order for the purpose of refills must maintain the same information and record keeping requirements as do pharmacies with manual, nonelectronic record keeping systems.

XXVI. GENERIC SUBSTITUTION:A. Substitution of generic drugs for brand name drugs.41

1. In accordance with this Code section, a pharmacist may substitute a drug with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed brand name drug product which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent. 2. If a practitioner of the healing arts prescribes a drug by its generic name, the pharmacist shall dispense the lowest retail priced drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent. 3. Substitutions as provided for in subsections (a) and (b) of this Code section are authorized for the express purpose of making available to the consumer the lowest retail priced drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, both therapeutically equivalent and pharmaceutically equivalent. 4. Whenever a substitution is made, the pharmacist shall record on the original prescription the fact that there has been a substitution and the identity of the dispensed drug product and its manufacturer. Such prescription shall be made available for inspection by the board or its representative in accordance with the rules of the board.

XVII. PATIENT COUNSELING: B. Patient counseling, as described in this Code section, shall not be required for:

1. Inpatients of a hospital or institution where other health care professionals are authorized to administer the drug or drugs 2. Inmates of corrections institutions where pharmacy services are provided by the Department of Corrections or by a county or municipal political subdivision either directly or by a subcontractor of the above 3. Patients receiving drugs from the Department of Public Health, provided, however, that pharmacists who provide drugs to patients in accordance with Code Section 43-34-23 shall include in all dispensing procedures a written process whereby the patient or the caregiver of the patient is provided with the information required under this Code section

VIII. CHANGE NOTIFICATIONS

A. Change of ownership, management, or location of a licensed pharmacy or other occurrences which require immediate notification to the board of pharmacy.15 B. Change of the pharmacist in charge of a licensed pharmacy, which requires immediate notification. C. Notice of any change of employment or change of business address shall be filed with the division director within ten days aer such change.

"Drug researcher

means a person, firm, corporation, agency, department, or other entity which handles, possesses, or utilizes controlled substances or dangerous drugs, as defined in Chapter 13 of Title 16, for purposes of conducting research, drug analysis, animal training, or drug education, as such purposes may be further defined by the board, and is not otherwise registered as a pharmacist, pharmacy, drug wholesaler, distributor, supplier, or medical practitioner.

XVII. PATIENT COUNSELING A. Upon receipt of a prescription drug order and following a review of the patient's record, the pharmacist or the pharmacy intern operating under the direct supervision of the pharmacist shall personally oer to discuss matters which will enhance or optimize drug therapy with each patient or caregiver of such a patient.24 Such discussion shall be in person, or by telephone and shall include appropriate elements of patient counseling, based on the professional judgment of the pharmacist. Such elements may include, but are not limited to, the following:

2. The dosage form, dose, route of administration, and duration of therapy 3. The intended use of the drug and expected action or result 4. Any special directions or precautions for preparation, administration, or use by the patient 5. Common severe side eects or adverse eects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if such side eect, adverse eect, interaction, or therapeutic contraindication occurs 6. Techniques for self-monitoring of drug therapy 7. The proper storage of the drug 8. Prescription refill information 9. The action to be taken in the event of a missed dose 10. The comments of the pharmacist relevant to the patient's drug therapy, including any other information peculiar to the specific patient or drug

XIII. COPIES OF PRESCRIPTION ORDERS A. Only a licensed pharmacist or a licensed pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, may prepare, receive, read, or transfer a copy of a prescription drug order to any person, and then only to a licensed pharmacist or licensed pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, who is authorized to receive and give such information as follows: When a prescription drug order copy is either sent or received by aid of a computer, or other electronic means, the pharmacist or pharmacy intern/extern should use the procedures for prescription drug order transfers detailed in Rule____

480-27-.07.

"Reverse drug distributor"

means a person, firm, or corporation which receives and handles drugs from within this state which are expired, discontinued, adulterated, or misbranded, under the provisions of Chapter 3 of this title, the "Georgia Drug and Cosmetic Act," from a pharmacy, drug distributor, or manufacturer for the purposes of destruction or other final disposition or for return to the original manufacturer of a drug.

VI. PHARMACY TECHNICIANS

A. Eective August 1, 2011, a pharmacy may only employ registered pharmacy technicians to perform pharmacy technician duties.10 B. In order to be registered as a pharmacy technician in this state, an applicant shall: 1. Submit an application to the board on the form prescribed by the board; 2. Attest that applicant is at least 17 years old; 3. Attest that applicant is currently enrolled in high school, or has a high school diploma, or has a GED, or has a postsecondary education or college degree; 4. Consent to provide the necessary information to conduct, and pay for a background check to be conducted by the board, its agent, or a firm or firms approved by the board. The background check will include a criminal history, driver license history, and other information as the board deems necessary, and will authorize the board and the Georgia Drugs and Narcotics Agency to receive the results; 5. Submit the name and address of employer and place of employment; 6. Pay application fees; and 7. Submit evidence of training supporting designation as certified, if certified. a. The board may deny registration or conditionally grant registration for any of the reasons set forth in Code Sections 26-4-60 or 43-1-19. In addition, no pharmacist whose license has been denied, revoked, suspended, or restricted for disciplinary purposes shall be eligible to be registered as a pharmacy technician. b. The denial of an application for registration as a pharmacy technician shall not be a contested case and the applicant shall not be entitled to a hearing. c. A registration, once issued, is renewable biennially, upon payment of a fee. A registrant has a responsibility to update the board with a change of home address and employment address within ten (10) days of such change d. A pharmacist may only supervise three (3) pharmacy technicians (pharmacist: technician ratio 1:3): One of the three technicians must have successfully passed a certification program approved by the board of pharmacy, successfully passed an employer's training and assessment program which has been approved by the board of pharmacy, have been certified by either the Pharmacy Technician Certification Board or any other nationally recognized certifying body approved by the board of pharmacy.12 e. The board may consider and approve an application to increase the ratio in a pharmacy located in a licensed hospital. Such application must be made in writing and must be submitted to the board by the pharmacist in charge of a specific hospital pharmacy in this state.12 f. Pharmacy technicians in the dispensing area shall be easily identifiable.11 g. In addition to the utilization of pharmacy technicians, a pharmacist may be assisted by and directly supervise one pharmacy intern and one pharmacy extern. 8. The duties of the Pharmacist-in- Charge related to Registered Pharmacy Technicians. a. The pharmacist in charge must maintain registry and monitoring of each registered technician and provide updated information to the Board in accordance with Board rules and regulations

XXVII. PSEUDOEPHEDRINE PRODUCTS Over-the-counter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products containing Pseudoephedrine

A. No person shall obtain or attempt to obtain, sell, dispense, or otherwise distribute any exempt Schedule V controlled substance drug product containing pseudoephedrine as listed under O.C.G.A. 16-13-29(5), except as herein provided, and as in compliance with all other applicable state or federal laws, rules, and regulations. 1. All exempt Schedule V controlled substance pseudoephedrine containing drug products must be stored in a pharmacy's prescription department. 2. All pharmacy personnel who engage in the sale or distribution of exempt Schedule V controlled substance containing drug products must complete the DEA's self-certification training as required by the Combat Methamphetamine Epidemic Act of 2005. B. A registered pharmacist or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist may sell, dispense, or otherwise dispose of without prescription not more than 3.6 g every 24 hours, or a maximum of 9 g every 30 days, to each customer of a pseudoephedrine containing drug product, but only: 1. Aer applying reasonable means or eort to determine that such is to be used for legitimate medical purposes, following the proper record keeping procedures and ensuring the required information has been properly recorded in a logbook which contains either a written or electronic list of sales 2. For handwritten logbooks used to record patient information before the sale of an exempt Schedule V pseudoephedrine-containing drug product can take place a. A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist, must approve all such sales or transactions C. The patient must sign the logbook to acknowledge the sale and receipt of the pseudoephedrine-containing drug product. D. A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist, may personally, or may direct designated pharmacy to, ask the patient to produce a photo identification issued by a state or the federal government to use in verifying that the patient's name on the photo identification matches the name the patient wrote in the logbook. E. A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist, must or may direct designated pharmacy personnel to verify that the date and time of the sale and other information that has been entered in the logbook is correct by use of the patient's photo identification, and initial the logbook verifying the information for the sale as being correct. F. A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist, must approve all such sales or transactions. 1. To complete any sales transactions to a patient by entering, at a minimum, the name of the pseudoephedrine-containing drug product, strength, and quantity sold, and the patient's name, date of birth, address, and zip code. The pharmacy may require additional patient information for the logbook as long as the required information is obtained. 2. No registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist, can knowingly sell more than 9 g of pseudoephedrine to a patient in a 30-day period of time. G. All logbooks must be retained for a minimum period of 2 years from the date of the last recorded sale. 1. Logbooks must be kept in a secure location in the pharmacy and information contained in a logbook can be shared. a. To comply with state or federal laws and rules b. For a product recall c. With local, state, and federal law enforcement oicers, to allow logbook information to be inspected, copied

VII. PHARMACIST AND INTERN ACTIVITIES

A. Provide patient consultation/counseling B. Orally transfer prescription order information from one prescription drug outlet to another for the purpose of dispensing a prescription C. A prescription drug order may be accepted by a pharmacist or pharmacy intern or extern in written form, orally, via an electronic visual image prescription drug order, or via an electronic data prescription drug order.

X. UNLAWFUL ACTS It shall be unlawful for a person to perform or cause the performance of or aid and abet any of the following acts in this state:

A. Selling, distributing, or transferring a prescription drug to a person who is not authorized to receive the prescription drug under the law of the jurisdiction in which the person receives the prescription drug; B. Failing to maintain or provide pedigrees as required by the board; C. Failing to obtain, transfer, or authenticate a pedigree as required by the board; D. Providing the board or any of its representatives or any federal oicial with false or fraudulent records, including, but not limited to: . Falsified pedigrees 2. Making false or fraudulent statements regarding any matter within the provisions of this article E. Obtaining or attempting to obtain a prescription drug by fraud, deceit, or misrepresentation or engaging in misrepresentation or fraud in the distribution of a prescription drug; and F. Except for the wholesale distribution by manufacturers of a prescription drug that has been delivered into commerce pursuant to an application approved under federal law by the Food and Drug Administration, the manufacturing, repackaging, selling, transferring, delivering, holding, or oering for sale of any prescription drug that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or has otherwise been rendered unfit for distribution.

IX. UNPROFESSIONAL CONDUCT—GROUNDS FOR DISCIPLINE: The Board of Pharmacy may refuse to issue or renew, or may suspend, revoke, or restrict the licenses of, or fine any person pursuant to the procedures set forth in this Code section, upon one or more of the following grounds

A. Unprofessional conduct as that term is defined by the rules of the board. B. Incapacity that prevents a licensee from engaging in the practice of pharmacy with reasonable skill, competence, and safety to the public. C. Being guilty of one or more of the following: 1. A felony 2. Any act involving moral turpitude 3. Violations of the pharmacy or drug laws of this state, or rules and regulations, pertaining thereto, or of laws, rules, and regulations of any other state, or of the federal government D. Misrepresentation of a material fact by a licensee in securing the issuance or renewal of a license. E. Engaging or aiding and abetting an individual to engage in the practice of pharmacy without a license falsely using the title of "pharmacist" or "pharmacy intern," or falsely using the term "pharmacy" in any manner. F. Failing to pay the costs assessed in a disciplinary hearing. G. Becoming unfit or incompetent to practice pharmacy by reason of: 1. Intemperance in the use of alcoholic beverages, narcotics, or habit-forming drugs or stimulants. 2. Any abnormal physical or mental condition which threatens the safety of persons to whom such person may compound or dispense prescriptions, drugs, or devices or for whom he or she might manufacture, prepare, or package or supervise the manufacturing, preparation, or packaging of prescriptions, drugs, or devices; H. Being adjudicated to be mentally ill or insane. I. Violating any rules and regulations promulgated by the board. J. Promoting to the public in any manner a drug which may be dispensed only pursuant to prescription. K. Regularly employing the mails or other common carriers to sell, distribute, and deliver a drug which requires a prescription directly to a patient, provided, however, that this provision shall not prohibit the use of the mails or other common carriers to sell, distribute, and deliver a prescription drug directly to: 1. A patient or directly to a patient's guardian or caregiver or a physician or physician acting as the patient's agent for whom the prescription drug was prescribed if: i. Such prescription drugs are prescribed for complex chronic, terminal, or rare conditions; ii. Such prescription drugs require special administration, comprehensive patient training, or the provision of supplies and medical devices or have unique patient compliance and safety monitoring requirements; iii. Due to the prescription drug's high monetary cost, short shelf life, special manufacturer specified packaging and shipping requirements or instructions which require temperature sensitive storage and handling, limited availability or distribution, or other factors, the drugs are not carried in the regular inventories of retail pharmacies such that the drugs could be immediately dispensed to multiple retail walk-in patients; iv. Such prescription drug has an annual retail value to the patient of more than $10,000.00; v. The patient receiving the prescription drug consents to the delivery of the prescription drug via expedited overnight common carrier and designates the specialty pharmacy to receive the prescription drug on his or her behalf; vi. The specialty pharmacy utilizes, as appropriate and in accordance with standards of the manufacturer, United States Pharmacopeia, and Federal Drug Administration and other standards adopted by the State Board of Pharmacy, temperature tags, time temperature strips, insulated packaging, or a combination of these; and vii. The specialty pharmacy establishes and notifies the enrollee of its policies and procedures to address instances in which medications do not arrive in a timely manner or in which they have been compromised during shipment and to ensure that the pharmacy replaces or makes provisions to replace such drugs.

XIV. PRESCRIPTION REFILLS

A. When filling a prescription or refilling a prescription which may be refilled, the pharmacist shall exercise professional judgment in the matter.21 1. No prescription shall be filled or refilled with greater frequency than the approximate interval of time that the dosage regimen ordered by the prescriber would indicate, unless extenuating circumstances are documented which would justify a shorter interval of time before the filling or refilling of the prescription. B. The pharmacist who fills or refills a prescription shall record the date of dispensing and indicate the identity of the dispensing pharmacist on the prescription document or some other appropriate and uniformly maintained record. If this record is maintained on the original prescription document, the original dispensing and any refills must be recorded on the back of the prescription. C. No prescription drug order for a C-III, IV, or V controlled substance shall be filled or refilled more than six (6) months aer the date on which such prescription drug order was issued by the prescribing practitioner and no such prescription drug order may be authorized to be refilled for the quantity prescribed more than five (5) times. 1. For controlled substances, nothing shall prohibit the refilling of such a prescription drug order in amounts less than the quantity prescribed as long as the total number of dosage units authorized for dispensing both the original quantity plus the refill quantities does not exceed six (6) months. 2. The prescribing practitioner may authorize additional refills of the original C-III, IV, or V controlled substance prescription drug order through an oral refill authorization transmitted directly to the pharmacist or pharmacy intern/extern working under the direct supervision of a licensed pharmacist provided the following conditions are met: a. The pharmacist or pharmacy intern/extern that receives the oral authorization shall record on the reverse side of the original prescription drug order the date, quantity of refill, number of additional refills authorized (for the quantity prescribed), and the initials showing who received the authorization from the prescribing practitioner that issued the original prescription drug order. b. The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription drug order. c. The prescribing practitioner must execute or authorize a completely new and separate prescription drug order for any additional quantities beyond the five (5) refills and/or six (6) month limitation. d. If the authorization comes from a practitioner that is not the original prescriber, the authorization shall be treated as a new prescription drug order authorized by the new prescribing practitioner. e. An automated data processing (ADP) or computerized system may be used for the storage and retrieval of refill information for prescription drug orders for C-III, IV, or V substances, subject to the requirements as set forth in Rule 480-27-.04. D. The date of each refilling of a prescription drug order shall be entered on the back of the prescription drug order or in a computerized record system, with which all documents must be uniformly maintained and readily retrievable. E. If the pharmacist initials and dates the back of the prescription drug order, it shall be deemed that the full face amount of the prescription has been dispensed. If an amount other than the full face amount is dispensed, the quantity shall be noted next to the initials of the pharmacist.

Hard copy prescription drug order"

Means a written, typed, reproduced, or printed prescription drug order prepared on a piece of paper.

Physician Assistant (PA) Masters or equivalent

Must be within the scope of practice of supervising physician. Written prescription must be on supervising physician's prescription order form. Must have own DEA number to prescribe controlled substances; may not perform an abortion or administer, prescribe, or issue a drug order that is intended to cause an abortion to occur pharmacologically. Also, they may not issue a written prescription for a Schedule II controlled substance; controlled prescriptions written from PA cannot be filled out of state.

II. GEORGIA DRUG AND NARCOTIC AGENCY: Duties and Responsibilities, 6. Perform such other duties as may be directed by the board. such as

a. The director, deputy director, and special agents of the Georgia Drugs and Narcotics Agency shall have the authority and power that sheris possess to make arrests of any persons violating or charged with violating Chapter 13 of Title 16 and Chapter 3 of this title and this chapter. The deputy director and special agents shall be required to be P.O.S.T.-certified peace oicers under Chapter 8 of Title 35, the "Georgia Peace Oicer Standards and Training Act." b. In case of such arrest, the director, deputy director, or any of the special agents shall immediately deliver the person so arrested to the custody of the sheri of the county wherein the oense is alleged to have been committed. The duty of the sheri in regard to the person delivered to the sheri by any such person arrested under power of this Code section shall be the same as if the sheri had made the original arrest. c. When the deputy director or a special agent employed by the Georgia Drugs and Narcotics Agency leaves the agency under honorable conditions aer accumulating 25 years of service in the agency, as a result of a disability arising in the line of duty, or pursuant to approval by the State Board of Pharmacy, such director or agent shall be entitled to retain his or her weapon and badge pursuant to approval by the State Board of Pharmacy, and, upon leaving the agency, the director of the Georgia Drugs and Narcotics Agency shall retain his or her weapon and badge pursuant to approval by the State Board of Pharmacy. d. Except as otherwise provided in this chapter, upon receiving a summary report from agency personnel, the director shall report to the board what have been determined to be violations of the drug laws and rules over which the board has authority. Aer such reports have been made to the board, the board can instruct the director to: i. Cite any such person or establishment to appear before the cognizant member of the board for an investigative interview. ii. Forward such reports to the Attorney General's oice for action decided on by the board. iii. Take whatever other action the board deems necessary. e. The Georgia Drugs and Narcotics Agency shall compile and submit to the General Assembly during each annual legislative session a list of known dangerous drugs as defined in subsection (a) of Code Section 16-13-71. i. The State Board of Pharmacy is authorized and directed to publish in print or electronically and distribute the "Dangerous Drug List" as prepared by the Georgia Drugs and Narcotics Agency and the "Georgia Controlled Substances Act" as enacted by law. ii. The Georgia State Board of Pharmacy shall provide for a fee as deemed reasonable or at no cost, such number of copies of the "Dangerous Drug List" and "Georgia Controlled Substances Act" to law enforcement oicials, school oicials, parents, and other interested citizens as are required.

XIII. COPIES OF PRESCRIPTION ORDERS A. Only a licensed pharmacist or a licensed pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, may prepare, receive, read, or transfer a copy of a prescription drug order to any person, and then only to a licensed pharmacist or licensed pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, who is authorized to receive and give such information as follow: When a copy of prescription drug order is received manually, meaning without the use of a computer or other electronic means, the person receiving such copy shall immediately reduce the information to writing by creating a hard copy prescription drug order which, besides the required prescription data, should include at a minimum the following information:

a. The name of the pharmacist or pharmacy intern/extern who received the prescription drug order b. The name of the transferring pharmacy and its telephone number along with the name of the pharmacist or pharmacy intern/extern who provided the information for the prescription drug order copy c. The date the prescription drug order copy was received

"Remote automated medication system"

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.

"Person"

an individual, corporation, partnership, or association.

Optometrist OD

any prescription drug for the treatment of ocular disease; they can prescribe nonnarcotic oral analgesics, Schedule III or Schedule IV controlled substances which are oral analgesics (used for no more than 72 hours without consultation with the patient's physician), or oral and topical antibiotics, antivirals, topical steroids, antifungals, antihistamines, or antiglaucoma agents related to the diagnosis or treatment of diseases and conditions of the eye and adnexa oculi.

"Pharmaceutically equivalent

drug products that contain identical amounts of the identical active ingredient, in identical dosage forms, but not necessarily containing the same inactive ingredients.

XX. COMPOUNDING: Compounding means

eans 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.27 Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine and regularly observed prescribing patterns. It does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling

Labeling

eans the process of preparing and aixing a label to any drug container exclusive, however, of the labeling by a manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or device. Any such label shall include all information required by federal, state, or federal and state law or rule.

"Generic name"

means a chemical name, a common or public name, or an oicial name used in an oicial compendium recognized by the Federal Food, Drug, and Cosmetic Act, as amended.

. "Nonprescription drug

means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.

"Prescription drug" or "legend drug"

means a drug which, under federal law, is required, prior to being dispensed or delivered, to be labeled with either of the following statements: "Caution: federal law prohibits dispensing without prescription" or "Caution: federal law restricts this drug to use by, or on the order of, a licensed veterinarian"; or a drug which is required by any applicable federal or state law or rule to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only; or a controlled substance, as defined in paragraph (6) of this Code section or a dangerous drug

"Controlled substance"

means a drug, substance, or immediate precursor in Schedules I through V of Code Sections 16-13-25 through 16-13- 29, Schedules through V of 21 C.F.R. Part 1308, or both.

Significant adverse drug reaction

means a drug-related incident that may result in serious harm, injury, or death to the patient.