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Chapter 480-13 HOSPITAL PHARMACY REGULATIONS

Rule 480-13-.01 Definitions

For purposes of these Rules and Regulations, the following definitions apply:

(a) Hospital. As defined by the Department of Human Resources;
(b) Hospital pharmacy. Hospital pharmacy is defined as that portion of a hospital facility which is engaged in the manufacture, production, sale and distribution of drugs, medications, devices, and other materials used in the prevention, diagnosis and treatment of injury, illness and disease (hereinafter referred to as "drugs"); and which is registered with the State Board of Pharmacy pursuant to O.C.G.A. § 26-4-110;
(c) Hospital pharmacy license. Hospital pharmacy license shall mean a pharmacy license issued by the Georgia State Board of Pharmacy to said hospital pharmacies, pursuant to the provisions of O.C.G.A. Sections 26-4-27, 26-4-28 and 26-4-110 whereas the licensee shall be subject to special hospital pharmacy regulations as set forth herein, but exempt from other certain regulations and requirements. To obtain the hospital pharmacy license, there must be employed a Director of Pharmacy.
1. The Board authorizes the holder of a hospital pharmacy license to service patients of Nursing Homes, Long Term Care Facilities or Hospices as long as these entities are under the same ownership as the hospital pharmacy; however, such entities can only be serviced by the hospital pharmacy subject to the requirements as set forth by Georgia State Board of Pharmacy Rules 480-24, the rule for providing services to nursing homes, long term care facilities, and hospices. The hospital pharmacy is prohibited from maintaining standard ward (Floor Stock) inventories in such entities, but, it would allow the hospital pharmacy to supply emergency kits.
(d) In-patient. In-patient shall mean a patient who is confined to the hospital;
(e) Out-patient. Out-patient shall mean a patient who is not an in-patient, including patients on leave of absence;
(f) Remote Location. Remote location shall mean a location away from the hospital or hospital pharmacy located within the United States where a pharmacist reviews and enters patient specific prescription drug orders for a hospital's patients.
(g) Remote Order Entry. Remote order entry shall mean the entry made by a pharmacist licensed in this state, who is an employee or contractor of either a pharmacy licensed in this state or a pharmacy that holds a Georgia nonresident pharmacy permit issued pursuant to Code Section 26-4-114.1, from a remote location anywhere in the United States indicating that the pharmacist has reviewed the patient specific drug order for a hospital patient, has approved or disapproved the administration of the drug for said patient, and has entered the information in the hospital's patient record system.
(h) Remote Order Entry Pharmacist. A remote order entry pharmacist shall mean a pharmacist who is licensed to practice pharmacy in the State of Georgia, who is at a remote location located within the United States, who is an employee or contractor of a pharmacy licensed in this state or that holds a nonresident pharmacy permit issued pursuant to Code Section 26-4-114.1, and who is under contract with or employed by the hospital to review and enter patient specific prescription drug orders for hospital patients when the hospital pharmacy is closed.
(i) Standard ward inventory. The Director of Pharmacy or his/her pharmacist designee may, in the best interest of the patients served, establish one or more lists of the kind and quantity of legend drugs to be kept at one or more locations at all times within said hospital and such stocks of legend drugs shall be known as standard ward inventory. The use of standard ward inventory shall be minimized. A copy of the list of items on standard ward inventory must be kept by the Director of Pharmacy or his/her pharmacist designee. A standard ward inventory may be placed on an emergency vehicle licensed with the State Department of Human Resources. A contract or agreement must be signed between the hospital and the ambulance service and filed with the Department of Human Resources Licensure Division and the Georgia Drugs and Narcotics Agency (GDNA) before any legend drugs may be placed on said licensed vehicle. An agreement can be made with only one hospital.

Rule 480-13-.02 Licensure and Registration

All hospital pharmacies shall renew biennially by June 30th of each odd-numbered year with the Georgia State Board of Pharmacy; certificates of registration shall be issued only to those hospital pharmacies which comply with the provisions of O.C.G.A. § 26-4-110, and with these Rules and Regulations.

(a) Minimum Required Information for Licensure. The Board requires the following information from each hospital pharmacy as part of the initial licensing procedure and as part of any renewal of such license:
(b) The name, complete street address for the business, and telephone number of the applicant/licensee;
(c) All trade or business names used by the applicant/licensee;
(d) Address, telephone numbers, and the name(s) of the Hospital Administrator;
(e) The type of ownership or operation (i.e., partnership, corporation, or sole proprietorship); and
(f) The name(s) of the owner and/or operator of the applicant/licensee, including:
1. If a partnership, the name of each partner, and the name of the partnership;
2. If a sole proprietorship, the complete name of the proprietor;
3. If a corporation, the name and title of each corporate officer and director, the corporate name and the state of incorporation; and the name of the parent company, if any.
(g) Where operations are conducted at more than one location by a single hospital pharmacy, each such location shall be licensed by the Board.
1. Applications for Licensure.
(i) Registration of a hospital pharmacy shall be considered filed with the Board when an application is received by the Board, and the fee is paid, and a report from the Director of the Georgia Drugs and Narcotics Agency (GDNA) certifying the applicant possesses the necessary qualifications for a license is received by the Board.
(h) Application fees shall not be refundable.
(i) A license shall be null and void upon the sale, transfer or change of mode of operation or location of the business.
(j) Licenses may be renewed for two year periods and shall expire on June 30th of each odd numbered year and may be renewed upon the payment of the required fee for each place of business and the filing of an application for renewal for each place of business. If the application for renewal is not filed with the Board, and the fee paid before September 1st of each odd numbered year, the license shall lapse and may not be renewed except by application for a new license.
(k) A licensee must submit any change of name, mode of operation or address to the Board prior to such change.
1. Minimum Qualifications.
(i) The Board shall consider the following factors when determining eligibility for licensure for each person in charge of the facility and when considering an application for a hospital pharmacy license:
(I) Any convictions of the applicant under any Federal, State, or local laws relating to drugs, wholesale or retail drug distribution, or distribution of controlled substances;
(II) Any felony convictions of the applicant under any Federal, State, or local laws;
(III) The furnishing by the applicant of false or fraudulent material or information in any application;
(IV) Suspension or revocation by any Federal, State, or local government of any pharmacist, pharmacy or other health care license currently or previously held by the applicant;
2. Failure to comply with any licensing requirements under a previously held license, if any;
3. Failure to comply with any requirements to maintain records and/or make available, said records to any State Licensing Authority or to any Federal, State, or local law enforcement officials;
4. Other factors or qualifications the Board considers relevant to and consistent with the public's health and safety;
5. The Board reserves the right to deny a license to an applicant if it determines that the granting of such a license would not be in the best interest of the public.

Rule 480-13-.03 Personnel

(1) Director of Pharmacy. Each hospital pharmacy shall be directed by a pharmacist, hereinafter referred to as the Director of Pharmacy, who is licensed to engage in the practice of pharmacy in this State, and who is knowledgeable in and thoroughly familiar with the specialized functions of hospital pharmacies. The Director of Pharmacy shall be responsible for all activities of the hospital pharmacy, and for meeting the requirements of the Georgia Pharmacy Laws and Rules and Regulations of the Board of Pharmacy. The Director of Pharmacy or his/her pharmacist designee should be employed on a fulltime basis consistent with need.
(2) Supportive personnel. The Director of Pharmacy shall be assisted by a sufficient number of additional pharmacists, and ancillary personnel as may be required to operate such pharmacy competently, safely, and to meet the needs of the patients of the hospital facility.
(a) The Director of Pharmacy shall insure that trained personnel shall be employed in the pharmacy. The Director of Pharmacy shall develop and implement written policies and procedures to specify the duties to be performed by such personnel. These policies and procedures shall, at a minimum, specify that such personnel are personally and directly supervised by a licensed pharmacist and that such personnel are not assigned duties which may be performed only by licensed pharmacists. The Director of Pharmacy shall be responsible for the implementation of the written policies and responsible to the Georgia State Board of Pharmacy for the activities of the pharmacy.
(b) Secretarial and clerical assistance and support shall be provided as required to assist with record keeping, report submission, and other administrative duties, provided such personnel do not perform any dispensing duties.
(c) Any licensed pharmacist performing pharmaceutical duties within the hospital shall operate and fall under the supervision of the Director of Pharmacy.
(3) Supervision. All of the activities and operations of each hospital pharmacy shall be personally and directly supervised by its Director of Pharmacy. All functions and activities of non-licensed pharmacy personnel shall be personally and directly supervised by an adequate number of licensed pharmacists to insure that all such functions and activities are performed competently, safely, and without risk of harm to patients. Personal supervision can only be accomplished by the physical presence of a licensed pharmacist in the hospital.

Rule 480-13-.04 Absence of Pharmacist

(1) General. When a licensed pharmacist is not physically present in the hospital and the pharmacy is closed, written policies and procedures shall be prepared in advance by the Director of Pharmacy for the provision of drugs to the medical staff and other authorized personnel of the hospital by use of night cabinets and/or by access to the pharmacy. The policies and procedures may include the use of remote order entry pharmacist to ensure that in-patient needs are met at the hospital when a licensed pharmacist is not physically present. All policies and procedures providing for the use of night cabinets and/or access to the pharmacy when a licensed pharmacist is not physically present shall be made available to the Georgia State Board of Pharmacy, its designee, or a representative of the Georgia Drugs and Narcotics Agency (GDNA), upon request.
(2) A hospital utilizing a remote order entry pharmacist shall maintain a record of the name and address of such pharmacist, evidence of current licensure in the State of Georgia, and the address of each location where the pharmacist will maintain records of remote order entries.
(3) A hospital pharmacy shall be authorized to utilize remote order entry when:
(a) The licensed pharmacist is not physically present in the hospital, the hospital pharmacy is closed, and a licensed pharmacist will be physically present in the hospital pharmacy within 24 hours or the next business day;
(b) When at least one licensed pharmacist is physically present in the hospital; or
(c) When it is a weekend and at least one pharmacist is physically present in another hospital in this state which remotely serves on weekends not more than four other hospitals under the same ownership or management which have an average daily census of less than twelve acute patients.
(4) Before a hospital may engage in remote order entry as provided in this paragraph, the director of pharmacy of the hospital shall submit to the board written policies and procedures for the use of remote order entry. The required policies and procedures to be submitted to the board shall be in accordance with the American Society of Health-System Pharmacists and shall contain provisions addressing:
(a) quality assurance and safety,
(b) mechanisms to clarify medication orders,
(c) processes for reporting medication errors,
(d) documentation and record keeping,
(e) secure electronic access to the hospital pharmacy's patient information system and to other electronic systems that the on-site pharmacist has access to,
(f) access to hospital policies and procedures, confidentiality and security, and
(g) mechanisms for real-time communication with prescribers, nurses, and other care givers responsible for the patient's health care.
(5) Each remote entry record must comply with all recordkeeping requirements and shall identify, by name or other unique identifier, the pharmacist involved in the preview and verification of the order. The remote entry pharmacist shall maintain records of any and all records entered for the hospital for a minimum of two (2) years, and such records shall be readily available for inspection, copying by, or production of upon request by the Board, its designee, or a representative for the Georgia Drugs and Narcotics Agency (GDNA), upon request.
(6) If the board concludes that the hospital's actual use of remote order entry does not comply with this rule or O.C.G.A. 26-4-80, it may issue a cease and desist order after notice and hearing.
(7) Night cabinets. Access to drugs, in the absence of a licensed pharmacist, shall be by locked cabinet(s) or other enclosure(s) constructed and located outside of the pharmacy area to which only specifically authorized personnel as indicated by written policies and procedures may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons. The Director of Pharmacy shall, in conjunction with the appropriate committee of the hospital, develop inventory listings of those drugs to be included in such cabinet(s) and shall insure that:
(a) Such drugs are available therein, properly labeled, with drug name, strength, lot number and expiration date;
(b) Only pre-packaged drugs are available therein, in amounts sufficient for immediate therapeutic requirements;
(c) Whenever access to such cabinet(s) has been gained, written practitioner's orders and proofs of use for controlled substances must be provided;
(d) All drugs therein are inventoried no less than once per week. A system of accountability must exist for all drugs contained therein; and
(e) Written policies and procedures are established to implement the requirements of this subsection.
(8) Access to pharmacy. Whenever a drug is not available from floor supplies or night cabinets, and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drug may be obtained from the pharmacy pursuant to the practitioner's order and the requirements of this subsection. One nursing supervisor (registered professional nurse or licensed practical nurse) in any given shift may have access to the pharmacy and may remove drugs there from. Such licensed nurse shall be designated in writing by the Director of Pharmacy of the hospital and shall, prior to being permitted to obtain access to the pharmacy, receive thorough education and training approved by the Director of Pharmacy, in the proper methods of access, removal of drugs, and records and procedures required. The Director of Pharmacy, or designee, shall document the nurse's competence following the education and training. In addition, such licensed nurse accessing a closed pharmacy must receive specific step-by-step instructions in a policy manual, approved by the Director of Pharmacy, before accessing the pharmacy. At any time that a nurse is accessing a closed pharmacy, the Director of Pharmacy must designate a licensed pharmacist, not a remote order entry pharmacist, who is available to the nurse by telephone, and who, in the event of an emergency, is available to come to the hospital. When a nurse accesses drugs directly from the closed pharmacy, the nurse must:
(a) provide a copy of the order,
(b) document on a suitable form the name of the drug, the strength and amount of the drug removed, the date and time it was removed, and sign the form.
(c) The container from which the drug is removed shall then be placed conspicuously to be promptly reviewed and inspected by the next pharmacist coming on duty. The Director of Pharmacy's policies and procedures must provide that the next pharmacist physically coming into the pharmacy must document that they have reviewed the drugs removed and the orders filled.
(9) 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 sufficient time to prevent risk of harm to patients;
(b) Drugs included. The Director of Pharmacy and the medical staff 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 insure 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 staff 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 re-seal 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;
(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 re-sealed;
(i) Procedures. The Director of Pharmacy shall, in conjunction with the medical staff of the hospital, develop and implement written policies and procedures to insure compliance with the provisions of this subsection.
(10) Authoritative, current antidote information as well as the telephone number of the regional poison control information center shall be readily available in areas outside the pharmacy where these drugs are stored.
(11) Nothing in this rule shall be construed to relieve the hospital pharmacy of the requirement of having an on-site pharmacist to provide routine pharmacy services within the hospital in order to qualify as a licensed pharmacy.

Rule 480-13-.05 Physical Requirements. Amended

(1) Area. A hospital pharmacy shall have within the hospital which it serves, sufficient floor space allocated to it to insure 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 square feet per hospital bed, which includes all areas assigned and under the direct control of the Director of Pharmacy.
(a) The pharmacy of substance abuse treatment or mental health facility shall be exempt from the minimum square footage requirement provided that the pharmacy receives a satisfactory inspection from the Georgia Drugs and Narcotics Agency that shows that the pharmacy space is sufficient to supply the needs of the patients and that all aspect of the management and operations of the pharmacy comply with the law and the rules of the Board to ensure that the health, safety, and welfare of the patients served by the pharmacy are protected. No application for licensure of a pharmacy of a substance abuse treatment or mental health facility seeking an exemption shall be approved without a satisfactory inspection.
(b) "Mental health facility" shall mean a specialized hospital, inpatient unit, or other institution that is licensed to provide twenty-four (24) hour care and has as its primary function the diagnosing and treating of patients with psychiatric disorders.
(c) "Substance abuse treatment facility" shall mean a specialized hospital, inpatient unit, or other institution that is licensed to provide twenty-four (24) hour care and has as its primary function the diagnosing and treating of patients with substance use disorders.
(2) Equipment and supplies. Each hospital pharmacy shall have sufficient 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:
1. A refrigerator in operating condition with a thermometer, preferably a biological refrigerator;
2. A sink in operating condition with hot and cold running water;
3. A Class A Balance and an assortment of metric weights if utilizing a Class A Balance or a Class I or II Electronic Balance, if compounding onsite using components which must be weighed;
4. Graduates of assorted sizes;
5. Mortar and pestle;
6. Two (2) spatulas and a counting tray;
7. Typewriter, word processor, or computer with a label printer;
8. Pill tile; and
9. Other equipment as deemed necessary by the Director of Pharmacy.
(b) Parenteral solution additives area as required in 480-13-.06(2)(a);
1. Laminar flowhood; and
2. Facility for light-dark field examination.
(c) Storage and receiving area;
(d) Manufacturing and packaging area; and
(e) Office space area.
(3)
(a) The pharmacy of a substance abuse treatment or mental health facility shall be exempt from (2)(a)(3.), (2)(b)(1.), and (2)(b)(2.) under the following terms and conditions:
1. The Director of Pharmacy attests that the pharmacy will purchase only commercially prepared medications and intravenous preparations;
2. The Director of Pharmacy attests that no compounding will occur on-site;
3. The pharmacy includes the attestations in its application for licensure as a hospital pharmacy; and
4. The pharmacy receives a satisfactory inspection from the Georgia Drugs and Narcotics Agency that shows that in the absence of the equipment, the pharmacy is sufficient to supply the needs of the patients and that all aspect of the management and operations of the hospital pharmacy comply with the law and rules of the Board to ensure that the health, safety, and welfare of the patients served by the pharmacy are protected.
(b) No application for licensure of a pharmacy of a substance abuse treatment or mental health facility seeking an exemption shall be approved without a satisfactory inspection.
(c) "Mental health facility" shall mean a specialized hospital, inpatient unit, or other institution that is licensed to provide twenty-four (24) hour care and has as its primary function the diagnosing and treating of patients with psychiatric disorders.
(d) "Substance abuse treatment facility" shall mean a specialized hospital, inpatient unit, or other institution that is licensed to provide twenty-four (24) hour care and has as its primary function the diagnosing and treating of patients with substance use disorders.
(4) Each hospital pharmacy shall maintain a reference library which includes, at a minimum, the following:
(a) Copy of and/or electronic or computer access to the latest edition of the Georgia Pharmacy Practice Act, the Georgia Controlled Substances Act and the Rules and Regulations of the Georgia State Board of Pharmacy;
(b) Copies of and/or electronic or computer access to current reference materials appropriate to the practice of the hospital pharmacy;
(c) Copy of and/or electronic or computer access to the latest edition of the American Society of Health-system Pharmacists Formulary Service;
(d) Compatibility charts;
(e) Current drug interaction references;
(f) Current antidote information;
(g) Copy of and/or electronic access or computer access to the latest edition of text and reference works covering theoretical and practical pharmacy, reference materials on general, organic, pharmaceutical and biological chemistry, toxicology, pharmacology, sterilization and disinfection.
(5) Storage. All drugs shall be stored in the hospital pharmacy within designated areas which are sufficient to insure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security. Drug storage cabinets and unit dose carts at the nursing station shall be locked when the station is not in attendance by nursing personnel.
(6) Controlled drug storage for Schedule II drugs. An enclosed controlled room with limited access capable of showing forced entry is preferable. However, a safe or metal cabinet adequately locked that is permanently affixed to the structure is acceptable.
(7) Unattended areas. Whenever any area of a hospital pharmacy is not under the personal and direct supervision of authorized personnel, such areas shall be locked.
(8) Security. All areas occupied by a hospital pharmacy shall be capable of being locked by key or combination, so as to prevent access by unauthorized personnel by force. The Director of Pharmacy shall designate in writing, by name and specific area, those persons who shall have access to particular areas within the pharmacy. These areas shall meet the security requirements of Federal and State Laws and Regulations. Only those persons so authorized shall be permitted to enter these areas.
(9) Variances.
(a) The Director of Pharmacy may submit to the Board a typed request for a variance to the provisions relating to minimum equipment requirements. The reasons for the request for a variance must be included. A variance may be granted by the Board only when, in the judgment of the Board, there are sound reasons for granting the variance which relate to the necessary or efficient delivery of health care. After consideration by the Board, the Director of Pharmacy will be notified of the Board's decision in writing.
(b) If approved, said letter(s) will serve as proof of the Board's approval for each variance(s) indicated in the letter, and shall be posted next to the Georgia Drugs and Narcotics Agency inspection report.

Rule 480-13-.06 Drug Distribution Control

(1) General. A drug distribution system is the entirety of that mechanism by which a prescription drug order is executed, from the time the practitioner transmits the order either orally or in writing to an authorized health professional to the time the ordered drug is administered to the patient or delivered to the patient for self-administration.
(2) Responsibility. The Director of Pharmacy shall be responsible for the safe and efficient distribution, control, and accountability for drugs, including IV solutions and irrigation solutions. The other professional staff of the hospital shall cooperate with the Director of Pharmacy in meeting this responsibility and in ordering, administering, and accounting for the pharmaceutical materials to achieve this purpose. The Director of Pharmacy shall establish written procedures for the distribution of parenteral medications to achieve this goal. Accordingly, the Director of Pharmacy shall be responsible for, at a minimum, the following:
(a) The compounding, admixture, and quality control of large volume parenterals is the responsibility of a pharmacist and shall be prepared under a Laminar Flow Hood or utilizing such other equipment to protect the integrity of the product, within the pharmacy department. Individuals who prepare or administer large volume parenterals must have special training to do so. These functions of IV admixture compounding shall be done primarily by the pharmacy department with exceptions allowed for specialty-care areas such as Intensive Care Units, Cardiac Catheterization Laboratories Intensive Care Units, etc., during emergency situations, or during unattended hours of the pharmacy department. When any part of the above functions (preparing, sterilizing, and labeling parenteral medications and solutions) is performed within the hospital but not under direct pharmacist supervision, the Director of Pharmacy shall be responsible for providing written guidelines and for approving the procedures to assure that all pharmaceutical requirements are met;
(b) All drugs must be identified up to the point of administration;
(c) The pharmacy must receive a direct copy, electronic or mechanical copy of a practitioner's order before the first dose of medication is dispensed except as defined by hospital stat order policy;
(d) Utilization of a pharmacy-generated patient profile. The patient profile shall be the official record of medications dispensed to the patient. The patient profile or the ability to generate such profile electronically shall be under the control of the Director of Pharmacy for a period of two (2) years. The patient profile shall contain at a minimum:
1. Given and last name of the patient;
2. Age;
3. Sex;
4. Provisional diagnosis;
5. Room number;
6. Drug product dispensed, date dispensed, strength, dosage form, quantity and directions, and identification of dispensing pharmacist;
7. Identification or differentiation of controlled substances;
8. Intravenous therapy;
9. Selected medical data;
10. Drug history interview (when possible); and
11. Sensitivities and allergies to drugs and foods;
(e) No more than a 72-hour supply of a patient's medication shall be available at the patient-care area at any time except for those drugs in bulk packages which cannot be repackaged in unit-dose containers;
(f) Manufacture of drugs, if applicable;
(g) Establishment of specifications or use of compendia specifications for procurement of drugs, chemicals, devices and biologicals, subject to approval of the appropriate committee of the hospital;
(h) Participation in the development of a drug formulary for the hospital;
(i) filling and labeling all containers from which drugs are to be administered, after visual screening to determine that same are neither adulterated nor misbranded;
(j) Maintaining and making available a sufficient inventory of antidotes and other emergency drugs. Current antidote information, telephone numbers of regional poison control center(s) and other emergency assistance organizations, and other material and information as may be deemed necessary shall be maintained;
(k) Records of all transactions of the hospital pharmacy as may be required by law, and as may be necessary to maintain accurate control over the accountability for all pharmaceutical drugs,devices and materials. Nothing in this section shall prohibit the use of computer hard copy, where such copy meets all other requirements of the law;
(l) Participation in those aspects of the hospital patient care evaluation program which relate to pharmaceutical drug, device and material utilization and effectiveness; and
(m) Efficient messenger and delivery service to connect the pharmacy with appropriate parts of the facility throughout the normal workday.
(3) Labeling.
(a) For use inside the hospital, all drugs dispensed by a hospital pharmacy, including those for standard ward inventory, shall be dispensed in appropriate containers and adequately labeled so as to identify at a minimum, brand name or generic name, strength, lot number, and expiration date.
(b) For use outside the hospital, all drugs dispensed by a hospital pharmacy to patients about to be discharged or on leave of absence shall be labeled with the following information:
1. Name, address, and telephone number of the hospital pharmacy;
2. Date and identifying serial number;
3. Patient's give n and last name;
4. Name of drug, (brand or generic) and strength;
5. Directions for use by patient;
6. Name of prescribing practitioner;
7. Required precautionary information regarding controlled substances; and
8. Such other and further accessory cautionary information as may be required or desirable for proper use by and safety of the patient.
(c) Drugs added to parenteral solutions. Wherever any drugs are added to parenteral solutions, whether within or outside the direct and personal supervision of a licensed pharmacist, such admixture shall be labeled with a distinctive supplementary label indicating the name and amount of the drug added, date and time of addition, expiration date and time if applicable, and the identity of the person so adding.
(4) Discontinued drugs. The Director of Pharmacy shall develop and implement policies and procedures to insure that outdated drugs and containers with worn, illegible, or missing labels are returned to the pharmacy for proper disposition.
(a) Full doses of controlled substances prepared for administration and not given must be destroyed by a licensed pharmacist or a licensed nurse and one witness. Any portions of controlled substances discontinued and taken from a medication delivery device shall be destroyed by a licensed pharmacist or a licensed nurse and one witness. The two persons witnessing the destruction must sign the destruction record at the time of destruction. The destruction record shall be returned to the pharmacy and must be signed by the pharmacist who is ultimately responsible for the accuracy of the information contained therein.
(b) In accordance with the policies and procedures developed by the Director of Pharmacy, discontinued non-controlled substances dispensed to hospital patients shall be returned to the pharmacy and evaluated by the licensed pharmacist to assure the integrity of the medication. If the integrity can be assured, the medication may be returned to the hospital's drug distribution s system for re-issue. When the integrity cannot be assured, the medication must be separated immediately from the regular drug inventory and destroyed or transferred to a reverse distributor with a current license issued by the Board. The following method of destruction of non-controlled substances is approved by the Board for medications dispensed to hospital patients or patients residing in nursing homes or long term care units which are part of a hospital facility;
1. Placed in a secure storage area at the facility separated from other medications. The drugs may be destroyed at the facility by the pharmacist and another licensed healthcare practitioner designated by the facility. However, before the destruction can take place, it must be verified that an inventory has been taken and recorded. The facility must maintain a written record of the destruction and the inventory for a two year period. This record shall include at a minimum the date, time, and personnel involved with the destruction and the method of destruction; or
2. If the drugs are to be transferred to a reverse distributor with a current license issued by the Board, a record of the following must be maintained by the hospital pharmacy for a minimum of two years:
(i) An inventory of the drugs to be transferred including the names of the drugs; the dosage form(s) of the drugs and the quantity of the drugs; the inventory shall be verified by a pharmacy representative and a representative of the reverse distributor;
(ii) The date and time the drugs were taken from the pharmacy;
(iii) The name, Board permit number, address and telephone number of the destruction firm removing the drugs;
(iv) The name and signature of the responsible person representing the reverse distributor who is physically removing the drug(s);
(v) The name and signature of the pharmacist representing the pharmacy transferring the drug(s) to the reverse distributor.
(c) The following methods of destruction of controlled substances are approved by the Board of Pharmacy:
1. A securely attached wooden or metal cabinet within a locked limited-access area shall be used to store the drugs until the drugs are destroyed. When controlled drugs are discontinued or the patient expires, the medication shall be pulled from the active stock immediately and inventoried and verified by a pharmacist along with another licensed healthcare professional. The inventory must be recorded into a permanent record and the drugs shall then be placed in the aforementioned cabinet. This medication shall remain within the locked cabinet until such time as it is removed for destruction.
2. The pharmacist shall establish a form, which shall include the following data:
(i) Date of discontinuance or inventory date;
(ii) Name of patient;
(iii) Name of pharmacy;
(iv) Identifying serial numbers;
(v) Name and strength of the drug; and
(vi) Quantity of the drugs in container(s) at the time of inventory.
3. A licensed pharmacist or licensed nurse and one witness must destroy the drugs.
4. Inventory of the drugs included in the final destruction must be taken with one copy retained by the facility. The inventory shall be certified by the two witnesses present at the destruction in the following format:

"We, whose signatures appear below, certify that these controlled substances have been reconciled, accounted for, and destroyed at ___________________ (location) on _________ (date) at __________ o'clock. "

Name of drug

Strength of drug

Dosage form

Quantity of drug

__________________________

(Signature and Title)

__________________________

(Signature and Title)

__________________________

(Signature and Title)

5. The Board and/or the GDNA may prohibit any pharmacist or hospital pharmacy from utilizing this method.
(d) A method of off-site destruction allowable by the Board is as follows:
1. The drugs to be destroyed shall be immediately removed from the active stock and stored in a separate and secure location in the pharmacy until the drugs are transferred. When the drugs are transferred to a reverse distributor licensed by the Board, an inventory must be recorded and include the following information: the names of the drugs, the dosage forms of the drugs and the quantities of the drugs taken and witnessed by an authorized representative of the hospital pharmacy and the responsible person representing the reverse distributor.
2. A receipt including the date and time the drugs were taken from the pharmacy; the name, Board permit number, address and telephone number of the reverse distributor removing the drugs; the inventory of the drugs; the name, signature and title of the responsible person representing the reverse distributor; and the name, signature and title of the pharmacy representative transferring the drugs. This receipt/record must be maintained by the hospital pharmacy for a minimum of two years.
(5) Prescription drug orders. Drugs may be dispensed from the hospital pharmacy only upon written orders, direct or mechanical copies thereof, of authorized practitioners.
(a) Authorization. The appropriate committee of the hospital shall, from time to time as appropriate, designate those practitioners who are authorized to issue prescription drug orders to the pharmacy.
(b) Abbreviations. Orders employing abbreviations and chemical symbols shall be utilized and filled only if such abbreviations and symbols appear on a published list of accepted abbreviations developed by the appropriate committee of the hospital.
(c) Requirements - Prescription drug orders for drugs, devices or materials for use by in-patients. Prescription drugs orders for use by in-patients shall, at a minimum, contain:
1. Patient name and room number;
2. Drug name, strength, directions for use; and
3. Date and practitioner's signature.
(d) Requirements - Prescription drug orders for drugs, devices or materials for use by outpatients. Prescription drug orders for drugs, devices or materials for use by outpatients shall, at a minimum, contain all of the information required by Rule 480-13-.06(5)(c), and in addition include:
1. Quantity to be dispensed;
2. Practitioner's address and Drug Enforcement Administration identification code, if applicable, and
3. Patient's address, if applicable.
(6) Accountability of controlled drugs.
(a) Proof of use of controlled drugs on standard ward inventory. Proof of use of controlled substances and such other drugs as may be specified by the appropriate committee of the hospital, shall be submitted to the pharmacy, on forms provided by the pharmacy. Proof of use forms shall specify at a minimum:
1. Name of drug, strength, and dosage form;
2. Dose administered;
3. Name of authorized practitioner. This shall include, at a minimum, the initial and last name;
4. Given and last name of the patient;
5. Date and time of administration to the patient;
6. Signature of the individual administering, which shall include at a minimum, the initial, last name, and title;
7. Documentation of the destruction of any and all unused portions by two signature verifications;
8. Proof of receipt of the medications that bears identifying serial numbers; and
9. Date the medication was issued and the date that the proof of use form was returned to the pharmacy.
(b) Anesthesia departments that obtain controlled drugs from the hospital pharmacy must show accountability of the controlled drugs by proof of use as defined above.
(c) Use of computer generated hard copy is permitted where such copy meets all other requirements of the law.
(d) Any hospital pharmacy licensed by the Georgia State Board of Pharmacy and in which controlled substances are administered to patients, may make on-premises destruction of small quantities of controlled substances prepared for parenteral and oral administration provided:
1. The controlled substance is either a whole dose or a partial dose of a single-dosage unit; and
2. The single-dosage unit from which the ordered dose was prepared is the nearest possible size to the dose ordered.
(e) Perpetual inventory of Schedule II substances shall be required and accountability of said drugs shall be by a proof of use form.
(7) Recall. The Director of Pharmacy shall develop and implement a policy and procedure to assure that all drugs within the hospital included on a recall are returned to the pharmacy for proper disposition.
(8) Suspected adverse drug reactions. All suspected adverse drug reactions shall be reported immediately to the ordering authorized practitioner, the pharmacy, and to the appropriate committee of the hospital. An appropriate entry on the patient's medical record shall also be made.
(9) Records and reports. The Director of Pharmacy shall maintain access to and submit, as appropriate, such records and reports as are required to insure the patient's health, safety and welfare. Such records shall be readily available and subject to inspections by the Board of Pharmacy, the GDNA or its employees. These shall include, at a minimum, the following:
(a) Patient profile;
(b) Proof of use;
(c) Reports of suspected adverse drug reactions;
(d) Inventories of night cabinets and emergency kits/crash carts;
(e) Inventories of the pharmacy;
(f) Biennial controlled substances inventories;
(g) Alcohol and flammables reports; and
(h) Such other records and reports as may be required by state Law and the Rules and Regulations of the Board of Pharmacy.
(10) Standard ward inventory (floor stock). The pharmacy department may distribute drugs within a hospital for the purpose of establishing and/or maintaining a standard ward inventory. Such drugs may be distributed only upon a signed requisition from a nurse or other authorized representative of said hospital or by an inventory replacement system. These drugs may be administered only pursuant to a practitioner's order. This practitioner's order will be forwarded to the pharmacy and these medications will be recorded on the pharmacy patient profile. A record of administration of drugs administered to patients in ancillary areas such as but not limited to the operating room, emergency room, anesthesiology, and x-ray shall be forwarded to the pharmacy and these medications shall be recorded on the patient profile. A survey of usage trends of each standard ward inventory shall be prepared monthly. Such records shall be retained for a period of two years.
(11) Emergency room dispensing. An authorized practitioner may, when drugs or controlled substances are not otherwise available from a licensed pharmacy, dispense an emergency amount of medication, but only sufficient quantities until such time as medication can be obtained from a pharmacy licensed as a retail pharmacy. Nurses or other unauthorized personnel may not dispense medication from the emergency room. The total act of dispensing shall be performed by an authorized practitioner in accordance with Pharmacy Laws, Rules and Regulations. Such medications shall be labeled as required in Section 480-13-.06(3)(b).

Rule 480-13-.07 Administration of Drugs

(1) General. Drugs shall be administered only upon the orders of those members of the medical staff who have been granted staff privileges. Drugs shall be administered by authorized licensed personnel in accordance with policies and procedures specified by the appropriate committee of the facility, under applicable Law and Rules and Regulations, and by usual and customary standards of good medical practice. The Director of Pharmacy shall develop and implement policies and procedures concerning self-administration of medication.
(2) Self-administration. Self-administration of drugs by patients shall be permitted only when specifically authorized by the patient's authorized practitioner, provided, however, the patient has been educated and trained in the proper manner of self-administration and there is no risk of harm to the patient. The Director of Pharmacy shall develop policies and procedures relating to the self-administration of drugs.

Rule 480-13-.08 Drugs from Outside Sources

The Director of Pharmacy shall establish policies and procedures relating to drugs brought into the hospital by patients or patients' family members. Such drugs shall not be administered unless they can be precisely identified. Administration shall be pursuant only to an authorized practitioner's prescription drug order. If such drugs are not to be administered, the medication shall be returned to an adult member of the patient's family or stored by the pharmacy and re- turned to the patient upon discharge. Medications received from an outside source, but not to be administered, may not be stored on the patient care unit. 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 of Pharmacy.

Rule 480-13-.09 Investigational Drugs

Investigational drugs shall be properly labeled and shall be administered only under the personal and direct supervision of the principal practitioner- investigator or his/her authorized clinician(s) with prior approval of the appropriate committee(s) of the hospital. Investigational drugs shall be administered in accordance with an approved protocol that includes any requirements for a patient's appropriate informed consent. Nurses may administer such drugs only after they have been educated regarding such drugs by the clinician or the pharmacist. A central unit shall be maintained wherein essential information regarding such drugs may be obtained. Investigational drugs in use shall be properly stored, distributed, and controlled maintaining the confidentiality of patient-medical staff information. The Director of Pharmacy shall be responsible for policies and procedures concerning use of investigational drugs.

Rule 480-13-.10 Inspections

(1) Monthly. The Director of Pharmacy shall no less than once per month, personally or by qualified designee, inspect all matters within his/her jurisdiction and responsibility and make appropriate written records of such inspections. Such inspections shall, at a minimum, verify that:
(a) Drugs are dispensed only by licensed pharmacists or licensed pharmacy interns acting under the direct supervision of a licensed pharmacist;
(b) Non-licensed pharmacy personnel are properly directed and supervised;
(c) Drugs for external use are stored separately, and apart from drugs for internal use or injection;
(d) Drugs requiring special storage conditions to insure their stability are properly stored;
(e) No outdated drugs are stocked in the hospital pharmacy or the facility it serves;
(f) Distribution and administration of controlled substances are properly and adequately documented and reported by both pharmacy and other licensed medical personnel;
(g) Standard ward inventory (floor stock). Verification of standard ward inventory lists and accountability, including such updating, if applicable, are maintained;
(h) All necessary and required security and storage standards are met;
(i) Metric-apothecaries' weight and measure conversion tables and charts are available;
(j) All policies and procedures of the Director of Pharmacy and of appropriate committees of the hospital relevant to the pharmacy are followed;
(k) All discounted and out-dated medications are returned to the pharmacy for proper disposition; and
(l) Disinfectants and other similar supplies intended for external use are stored separately and apart from drugs intended for internal (oral) or parenteral use.
(2) Board Inspection. The Board of Pharmacy inspections shall be conducted by representatives of the Georgia Drugs and Narcotics Agency (GDNA) no less than once every two (2) years. Such inspections shall include all aspects of the management and operation of all hospital pharmacies in this State to verify compliance with the Pharmacy Laws, the Rules and Regulations of the Board of Pharmacy, and such other standards as may be appropriate to insure that the health, safety and welfare of patients of the hospital serviced by the pharmacy are protected. A written report shall be filed with the GDNA, the Director of Pharmacy, and the hospital administrator. Any discrepancies or deficiencies noted shall be corrected within a reasonable time. Written notice of such corrections shall be filed with the GDNA within thirty (30) days after receipt of the inspection notice.
(a) The Director of Pharmacy of each hospital pharmacy shall obtain a copy of the current Board permit of every drug wholesaler and/or reverse distributor from which controlled substances and/or dangerous drugs are purchased and/or returned. Such copies shall be made available during the GDNA's inspection.