Chapter 480-33 OUTPATIENT CLINIC PHARMACIES

Rule 480-33-.01 Definitions

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

Outpatient Clinic. An outpatient clinic shall be defined as a health care facility or location, other than a medical practitioner's office, providing outpatient treatment or case such as, but not limited to, an outpatient surgery center, outpatient urgent care center, infusion treatment center, or ambulatory care center.

(b)	Outpatient Clinic Pharmacy. An outpatient clinic pharmacy shall be defined as that part of an outpatient clinic health care facility engaged in the practice of pharmacy.

(c)

Outpatient Clinic Pharmacy License. An outpatient clinic pharmacy license shall be defined as a pharmacy license issued by the Georgia State Board of Pharmacy to Clinic pharmacies, pursuant to the provisions of O.C.G.A. Title 26, Chapter 4, whereas the licensee shall be subject to special outpatient clinic pharmacy regulations as set forth herein, but exempt from other certain regulations and requirements.

(d)	Outpatient. An outpatient shall be defined as an ambulatory patient who comes to an outpatient clinic to receive health care services related to the objectives of the outpatient clinic and departs within 24 hours.

(e)

Standard Ward Inventory. The pharmacist-in-charge of the outpatient clinic 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 drugs to be kept at one or more locations at all times within the outpatient clinic and such stocks of 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 pharmacist-in-charge or his/her pharmacist designee.

(f)

Outpatient Prescription. An outpatient prescription shall be defined as a prescription drug order prescribed by a medical practitioner engaged in the practice of that clinic and prescribed for services received in that clinic in conjunction with health care services related to the objectives of that clinic.

Rule 480-33-.02 Licensure and Registration

(1)

All outpatient clinic 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 to outpatient clinic pharmacies which meet the requirements for licensure and which comply with Chapter 480-33 of the Rules of the Georgia State Board of Pharmacy.

(2)

Minimum Required Information for Licensure. The Board requires the following information from each outpatient clinic pharmacy as part of the initial licensing procedure and as part of each renewal of such license. The name, complete street address for the business (i.e., geographic location), and telephone number of the applicant/ licensee. All trade or business names used by the applicant/licensee. Address, telephone numbers, and the name(s) of the clinic administrator;

(a)	The type of ownership or operation (i.e., partnership, corporation, or sole proprietorship); and

(b)

The name(s) of the owner and/or operator of the applicant/licensee, including:

1.	If a sole proprietorship, the complete name of the proprietor;

2.	If a partnership, the complete name of each partner, and the name of the partnership;

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.

(i)	Where operations are conducted at more than one location by a single outpatient clinic pharmacy, each such location shall be licensed by the Board.

(ii)

Applications for Licensure.

(I)

Registration of an outpatient clinic pharmacy shall be considered filed with the Board when an application is received by the Board, a fee paid, and a report from the Director of the Georgia Drugs and Narcotics Agency (GDNA) certifying that the applicant possesses the necessary qualifications for a license.

(II)	Application fees shall not be refundable.

(III)

Licenses shall become null and void upon the sale, transfer or change of mode of operation or location of the business.

(IV)

Licenses are renewed for two year periods and 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. 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. An application for reinstatement shall be required. Reinstatement shall be at the sole discretion of the Board.

(V)	Changes in any information in this section shall be submitted to the Board prior to such change.

(iii)

Minimum Qualifications.

(I)	To obtain an outpatient clinic pharmacy license, the outpatient clinic pharmacy must employ a pharmacist-in-charge.

(II)

The Board shall consider the following factors in determining eligibility for licensure for each person(s) in charge of the facility when considering an application for an outpatient clinic 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 of Federal, State, or local government of any pharmacist, pharmacy or other healthcare license currently or previously held by the applicant;

V.	Failure to comply with any licensing requirements under a previously held license, if any;

VI.	Failure to comply with any requirements to maintain and/or make available to the state licensing authority or to Federal, State, or local law enforcement officials, any records required to be maintained by outpatient clinic pharmacies;

VII.	Other factors or qualifications the Board considers relevant to and consistent with the public's health and safety; and

VIII.

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.

(3)	An outpatient clinic pharmacy registered with the Board shall not be authorized to dispense refills on prescription drug orders.

(4)

Nothing in these regulations shall be construed to prohibit an outpatient clinic from applying for a retail pharmacy license as provided for in O.C.G.A. §§ 26-4-110 and Rule 480-6-.01. Any retail pharmacy located in an outpatient clinic holding a retail pharmacy license, shall comply with all the laws, rules and regulations applicable to such licensed retail pharmacy.

(5)	Nothing herein shall be construed to interfere with a practitioner of the healing arts practicing as authorized by law.

Rule 480-33-.03 Personnel

The Personnel shall be as follows:

(a)

Pharmacist-in-charge. Each outpatient clinic pharmacy shall be directed by a pharmacist, hereinafter referred to as the pharmacist- in-charge, who is licensed to engage in the practice of pharmacy in this State, and who is knowledgeable in and thoroughly familiar with the specialize functions of outpatient clinic pharmacies. The pharmacist-in-charge shall be responsible for all activities of the outpatient clinic pharmacy, and for meeting the requirements of the Georgia Pharmacy Laws and Rules and Regulations of the Georgia State Board of Pharmacy. The pharmacist-in-charge shall be employed on a full-time or part-time basis consistent with the needs and objections of the outpatient clinic.

(b)

Supportive personnel. The pharmacist-in-charge of an outpatient clinic pharmacy shall be assisted by a sufficient number of additional pharmacists and non-licensed personnel, in ratios consistent with state law and Board Rules as may be required to operate such pharmacy competently, safely, and to meet the needs of the patients of the clinic facility.

1.

The pharmacist-in-charge shall insure that non-licensed personnel shall be adequately trained. The pharmacist-in-charge shall develop and implement written policies and procedures to specify the duties to be performed by such non-licensed personnel. These policies and procedures shall, at a minimum, specify that non-licensed personnel are personally and directly supervised by a licensed pharmacist and that non-licensed personnel are not assigned duties which may be performed only by licensed pharmacists.

2.	Secretarial and clerical personnel 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.

3.

Supervision. All of the activities and operations of each outpatient clinic pharmacy shall be personally and directly supervised by the pharmacist-in-charge or his/her pharmacist designee. All functions and activities of non-licensed 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 clinic pharmacy.

Rule 480-33-.04 Absence of Pharmacist

The following regulations shall be followed in the absence of a pharmacist:

(a)

General. When a licensed pharmacist is not physically present in the clinic pharmacy, written policies and procedures shall be prepared in advance by the pharmacist-in-charge for the provision of drugs to the medical staff and other authorized licensed personnel of the clinic by use of after hours cabinets or containers and/or by access to the pharmacy.

(b)

After hours cabinets or containers. Access to drugs, in the absence of a licensed pharmacist, shall be by locked cabinet(s) or other enclosure(s) or container(s) constructed and located outside of the pharmacy area to which only specifically authorized licensed clinic 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 pharmacist-in-charge shall, in conjunction with the appropriate committee of the outpatient clinic facility, develop inventory listings of those drugs to be included in such cabinet(s), enclosure(s) or container(s) and shall insure that:

1.	Such drugs available are properly labeled, with drug name, strength, lot number and expiration date;

2.	Only pre-packaged drugs are available therein, in amounts sufficient for immediate therapeutic requirements;

3.	Whenever access to such cabinet(s), enclosure(s) or container(s) shall have been gained, written practitioner's orders and proof of use for controlled substances are provided;

4.	All drugs therein are inventoried no less than once per week. A system of accountability must exist for all drugs contained therein; and

5.	Written policies and procedures are established to implement the requirements of this subsection.

(c)

Access to pharmacy. Whenever any drug is not available from standard ward inventories or after hours cabinet(s), container(s) or enclosure(s) 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 licensed health care professional as designated in the policies and procedures may have access to the pharmacy and may remove drugs therefrom. Such licensed health care professional shall be designated in writing by the pharmacist-in-charge of the outpatient clinic pharmacy and shall, prior to being permitted to obtain access to the pharmacy, receive thorough education and training in the proper methods of access, removal of drugs, and records and procedures required. Such education and training shall be given by the pharmacist-in-charge who shall require, at a minimum, the following records and procedures:

1.	Removal of any drug from the pharmacy by an authorized licensed health care professional must be recorded on a suitable form showing name of drug, strength, amount, date, time and signature of the designated licensed health care professional;

2.	The container from which the drug is removed shall be placed conspicuously in the pharmacy to be promptly reviewed and inspected by a pharmacist.

(d)

Emergency kits. Drugs may be provided for use by authorized health care personnel by emergency kits, provided such kits meet the following requirements:

1.	Emergency kit drugs defined. Emergency kit 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 within the clinic in sufficient time to prevent risk of harm to patients;

2.	Drugs included. The pharmacist-in-charge and the medical staff of the clinic shall jointly determine the drugs, by identity and quantity, to be included in emergency kits;

3.	Storage. Emergency kits shall be locked and stored in limited access areas to prevent unauthorized access, and to insure a proper environment for preservation of the drugs within them;

4.

Labeling - exterior. The exterior of emergency kits shall be labeled so as to clearly and unmistakably indicate that it is an emergency drug kit 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 the Board, the GDNA or one of their agents;

5.

Labeling - interior. All drugs contained in emergency kits 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 clinic to prevent misunderstanding or risk of harm to the patients;

6.	Removal of drugs. Drugs shall be removed from emergency kits only pursuant to a valid prescription drug order of an authorized prescribing practitioner, by authorized clinic personnel, or by a pharmacist of the clinic facility;

7.

Notification. Whenever an emergency kit is opened, the pharmacy shall be notified; and the pharmacy shall replace or re-stock and re-seal the kit within a reasonable time so as to prevent risk of harm to patients. In the event the kit is opened in an unauthorized manner, the pharmacy and other appropriate personnel of the facility shall be notified;

8.	Inspections. Each emergency kit shall be opened and its contents inspected by the pharmacy at least once every ninety (90) days. Upon completion of inspection, the emergency kit shall be resealed.

9.	Procedures. The pharmacist-in-charge shall, in conjunction with the medical staff of the clinic, develop and implement written policies and procedures to insure compliance with the provisions of this subsection.

(e)	Authoritative, current antidote information as well as the telephone number of the regional poison control information center shall be posted or readily available in areas outside the pharmacy where these drugs are stored or patients are being cared for.

Rule 480-33-.05 Physical Requirements

(1)

Area. An outpatient clinic pharmacy shall have within the clinic 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 outpatient clinic pharmacy space requirements shall be a minimum of 150 square feet. Such space shall include all areas which are assigned and under the direct control of the pharmacist-in-charge.

(2)

Minimum Equipment. No outpatient clinic pharmacy licensed in accordance with Title 26, Chapter 4 of the Official Code of Georgia Annotated shall engage in the practice of filing, compounding or dispensing prescription drugs unless it shall possess the following items:

(a)	Copies of and/or electronic access to current reference materials appropriate to the individual pharmacy practice. These reference materials shall be authoritative on at least the topics of drug interactions; patient counseling; compounding and pharmaceutical calculations; and generic substitution.

(b)	The telephone number of a poison control center. This number shall be conspicuously posted within the pharmacy and at other locations within the clinic facility.

(c)

Current copies of or computer or electronic access to the following:

1.	The Georgia Pharmacy Practice Act, O.C.G.A. Title 26, Chapter 4;

2.	The Georgia Controlled Substances Act/Dangerous Drug Act, O.C.G.A. Title 16, Chapter 13;

3.	Official Rules of the Georgia State Board of Pharmacy.

(d)

Equipment (appliances):

1.	Refrigerator in operating condition and a thermometer; and

2.	Sink in working condition with both hot and cold running water.

(e)

Weighing and labeling:

1.	Class A Balance, Class I or II Electronic Balance, or as approved by the Board;

2.	Assortment of weights: metric and apothecary;

3.	Appropriate prescription labels consistent with the requirements of the Georgia Drug and Cosmetic Act, O.C.G.A. Title 26, Chapter 3; and

4.	Appropriate auxiliary labels that should be used in the pharmacist's professional judgment.

(f)

Other equipment;

1.	Graduates of assorted sizes;

2.	Two mortars and pestles of assorted sizes;

3.	Two spatulas;

4.	One oral solid counting tray;

5.	Ointment slab, tile or ointment paper pad;

6.	Typewriter, word processor or computer with label printer; and

7.	Any other equipment necessary for a specialized practice setting where such a specialized practice takes place.

(g)	Adequate supply of drugs most commonly prescribed.

(h)	Assorted sizes and types of appropriate dispensing containers.

(3)

Variances.

(a)

The pharmacist-in-charge in an outpatient clinic facility may submit to the Georgia State Board of Pharmacy a typed request for a variance to these provisions relating to minimum equipment requirements. The reasons for the request for the variance must be included in the submitted request. A variance may be granted by the Board only when, in the judgment of the Board, there are sound reasons for doing so that relate to the necessary or efficient delivery of health care. After consideration by the Board, the requester will be notified of the Board's decision in writing.

(b)	If approved, said letter(s) will serve as the proof of the Board's approval for the variances indicated in the letter, and must be posted next to the facility's inspection report.

(4)

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 within the pharmacy. Other licensed healthcare professionals who are authorized by law to prepare or administer large volume parenterals must have special training to do so. These functions of compounding shall be done primarily by the pharmacy department with exceptions allowed for specialty-care areas, emergency situations, and during unattended hours of the pharmacy department. The pharmacist-in-charge shall be responsible for providing written guidelines and for approving the procedure to assure that all pharmaceutical requirements are met when any part of the above functions (preparing, sterilizing and labeling parenteral medications and solutions) is performed within the clinic by other licensed healthcare professionals who are authorized by law to prepare parenteral medications and solutions.

(5)

Storage. All drugs shall be stored in designated areas within the clinic pharmacy which are sufficient to insure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security. Drug storage areas shall be locked or otherwise secured when health care professionals are not present.

(6)	Controlled drug storage for Schedule II drugs. An enclosed controlled room or space with limited access capable of showing forced entry is preferable. However, a safe or metal cabinet that can be locked and that is permanently affixed to the structure is acceptable.

(7)	Unattended areas. Whenever any area of a clinic pharmacy is not under the personal and direct supervision of authorized personnel, such areas shall be locked.

(8)

Security. All areas occupied by a clinic 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, the name and specific area, of 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.

Rule 480-33-.06 Drug Distribution and 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, in writing, or electronically 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 pharmacist-in-charge 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 clinic shall cooperate with the pharmacist-in-charge in meeting this responsibility and in ordering, administering, and accounting for the pharmaceutical materials so as to achieve this purpose. The pharmacist-in-charge shall establish written procedures for the distribution of medications including standard ward inventory, emergency kits, etc. to achieve this goal.

(a)	The drugs must be identified up to the point of administration;

(b)	The pharmacy must receive a direct, electronic (only for drugs to be administered on site) or mechanical copy of a practitioner's order before the first dose of medication is dispensed except as defined by the clinic stat order policy;

(c)

Records of all transactions of the clinic pharmacy as may be required by law, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials within the scope of the clinic practice. Nothing in this section shall prohibit the use of computerized records, where such records meet all other requirements of the law. If an outpatient clinic pharmacy elects to dispense prescription medications other than outpatient prescriptions as defined herein, the pharmacy must meet all applicable State and Federal Laws and regulations and must also obtain a retail pharmacy permit; and

(d)	Participation in those aspects of the clinic patient care evaluation program which relate to pharmaceutical material utilization and effectiveness.

(3)

Labeling.

(a)	For use inside the clinic, all drugs dispensed by a clinic 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)

Drugs added to parenteral admixtures. Wherever any drugs are added to parenteral admixtures, 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 identity of person preparing the admixture.

(4)	Discontinued drugs. The pharmacist-in-charge shall develop and implement policies and procedures to insure that discontinued and outdated drugs and containers with worn, illegible, or missing labels are returned to the pharmacy for proper disposition.

(5)

Accountability of controlled drugs.

(a)

Proof of use of controlled drugs on standard ward inventory and/or those issued for a specific patient. Proof of use of controlled substances and such other drugs as may be specified by the appropriate committee of the clinic, shall be submitted to the pharmacy, on forms provided by the pharmacy. Proof of use forms shall specify at a minimum:

1.	Drug name, strength, and dosage form;

2.

Dose;

3.	Name of prescriber. This shall include, at a minimum, the given and last name;

4.	Given and last name of patient;

5.	Date and time of administration to patient;

6.	Signature of individual administering, which shall include at a minimum, the initial, last name and title;

7.	Documentation by two signature verifications of destruction of all unused portions;

8.	Proof of receipt of medications that bears identifying serial numbers; and

9.	Date medication was issued and the date that the proof of use form was returned.

(b)	Anesthesia, surgical, diagnostic and treatment departments that obtain controlled drugs from the clinic pharmacy must show accountability of the controlled drugs by proof of use as defined above.

(c)	Use of computer hard copy is permitted where such copy meets all other requirements of the law.

(d)

Any outpatient clinic pharmacy licensed by the Georgia State Board of Pharmacy 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 the remainder of a single-dose 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.

(f)	Recall. The pharmacist-in-charge shall develop and implement a recall policy and procedure to assure that all drugs within the clinic included on the recall are returned to the pharmacy for proper disposition.

(g)	Suspected adverse drug reactions. All suspected adverse drug reactions shall be reported immediately to the ordering practitioner, the pharmacy, and to the appropriate committee of the clinic. An appropriate entry on the patient's record shall also be made.

(h)

Records and reports. The pharmacist-in-charge shall maintain access to and submit, as appropriate, such records and reports as are required to insure patient health, safety and welfare. Such records shall be readily available and subject to inspections by the Board or its agents. These shall include, at a minimum, the following:

1.	Patient profile, chart or other appropriate record;

2.	Proof of use forms for controlled substances;

3.	Reports of suspected adverse drug reactions;

4.	Inventories of night cabinets, cabinets or enclosures; emergency drug kits; and standard ward inventories;

5.	Inventories of the pharmacy;

6.	Biennial controlled substances inventories;

7.	Alcohol and flammables reports; and

8.	Such other records and reports as may be required by law and the rules and regulations of the Georgia State Board of Pharmacy.

(i)

Standard Ward Inventory. The outpatient clinic pharmacy may distribute drugs within a clinic for the purpose of establishing and/ or maintaining a standard ward inventory. Such drugs may be supplied only upon a signed requisition from an authorized licensed health care professional of said clinic or by an inventory replacement system. These drugs may be administered only pursuant to a practitioner's order and shall be documented in the patient's record. A record of drugs administered to patients in ancillary areas such as surgical suite, treatment rooms, anesthesiology and diagnostic areas will become a part of the patient's record and shall be retrievable by the pharmacy. A survey of usage trends of each standard ward inventory shall be made monthly. Such records shall be maintained for a period of two years.

(j)	Security of controlled substances. Controlled drugs that are maintained as authorized standard ward inventory in patient care/ treatment areas outside the pharmacy shall be stored in secured cabinets or areas that provide a double lock system.

Rule 480-33-.07 Administration of Drugs. 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 laws and rules and regulations, and by usual and customary standards of good medical practice.

Rule 480-33-.08 Medications from Outside Sources Brought by Patients

The pharmacist-in-charge shall establish procedures relating to medications brought into the clinic. Such drugs shall not be administered unless they can be precisely identified. Administration shall be pursuant to an authorized practitioner's prescription drug order only. If such medications are not to be administered, the medication shall be returned to an adult member of the patient's immediate family or stored by the pharmacy and returned to the patient at the time of his/her departure from the clinic. 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 Georgia State Board of Pharmacy. These medications shall not be maintained in any of the ancillary areas of the clinic.

Rule 480-33-.09 Investigational Drugs

Investigational drugs shall be properly labeled. Investigational drugs shall be dispensed and administered by the pharmacist 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 by the practitioner or the pharmacist. A central unit shall be maintained by the pharmacy 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 pharmacist-in-charge shall be responsible for policies and procedures concerning the use of investigational drugs.

Rule 480-33-.10 Inspections

(1)

Monthly. The pharmacist-in-charge 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;

(b)	Pharmacy personnel are properly directed and supervised;

(c)	Drugs for external use are stored separately and apart from drugs for oral 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 outpatient clinic pharmacy or the facility it serves;

(f)	Distribution and administration of controlled substances are properly and adequately documented and reported by both pharmacy and medical personnel;

(g)	Standard Ward Inventory. 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-apothecary weight and measure conversion tables and charts and compatibility charts are available;

(j)	All policies and procedures of the director of pharmacy and of appropriate committees of the clinic relevant to the pharmacy are being followed;

(k)	All discontinued 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 for oral internal use or for parenteral injection.

(2)

Board Inspection. The agents of the Georgia Drugs and Narcotics Agency (GDNA) will conduct inspections on behalf of the Georgia State Board of Pharmacy. Such inspections shall be conducted no less than once every two years and cover all aspects of the management and operation of all outpatient clinic pharmacies in this State to verify compliance with the law, these rules and regulations of the Georgia State Board of Pharmacy, and such other standards as may be appropriate to insure that the health, safety, and welfare of patients of the clinic serviced by the pharmacy are protected. A written report shall be filed with the GDNA, the pharmacist- in-charge, and the clinic administrator. Any discrepancies or deficiencies noted shall be corrected within a reasonable time. Written notice of such corrections or a plan of action to correct deficiencies shall be filed with the Georgia State Board of Pharmacy and GDNA within thirty (30) days after receipt of the inspection report.

(a)

Every registrant should ensure that all controlled substances and/or dangerous drugs are purchased from and returned to firms currently licensed by the Georgia State Board of Pharmacy. This requirement shall be met by obtaining and maintaining a copy of each such firm's current Georgia Board permit.

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