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Chapter 480-8 PRISON CLINIC PHARMACIES

Rule 480-8-.01 Definitions

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

(a) Prison Clinic Pharmacy. Prison Clinic Pharmacy is defined as that portion of a prison correctional facility which is engaged in 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 Georgia State Board of Pharmacy pursuant to Chapter 26-4 of the Official Code of Georgia Annotated.
(b) Prison Clinic Pharmacy License. Prison Clinic Pharmacy licenses are issued by the Georgia State Board of Pharmacy to those said Prison Clinic Pharmacies, pursuant to the provisions of Chapter 26-4 of the Official Code of Georgia Annotated, whereas the license shall be subject to special prison clinic pharmacy regulations as set forth herein, but exempt from other certain regulations and requirements. To obtain the prison clinic pharmacy license, there must be a Director of Pharmacy Services.
(c) Inpatient. In-patient shall mean an inmate who is confined to an infirmary bed and is in the custody of and assigned to an institution operated under the authority of the Georgia Department of Corrections, or any county or municipal political subdivision.
(d) Outpatient. Out-patient shall mean an inmate who is in the custody of and assigned to an institution operated under the authority of the Georgia Department of Corrections, or any county or municipal political subdivision.
(e) Standard ward inventory. The Director of the prison clinic pharmacy or their 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 the said prison clinic 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 their pharmacist designee.
(f) Prison Clinic Administrator. The Prison Clinic Administrator is that individual prison official who is designated as the person responsible for the operation of the portion of a prison or other correctional institution responsible for the health care of the facility's inmates.

Rule 480-8-.02 Registration

(1) Every prison clinic pharmacy, wherever located within the State of Georgia must be licensed by the Georgia State Board of Pharmacy ("Board") in accordance with the laws and regulations of this State. All prison clinic pharmacies shall renew biennially by June 30th of the odd-numbered years with the Georgia State Board of Pharmacy; certificates of registration shall be issued only to those prison clinic pharmacies as follows:
(2) Minimum Required Information for Licensure: The Board requires the following information from each prison clinic pharmacy as part of the initial licensing procedure and as part of any renewal of such license.
(a) The name, full business address, and telephone number of the licensee;
(b) All trade or business names used by the licensee;
(c) Address, telephone numbers, and the name(s) of the Prison Clinic Administrator;
(d) The type of ownership or operations (i.e., partnership, corporation, or sole proprietorship); and
(e) The name(s) of the owner and/or operator of the licensee, including;
1. If a person, the name of the person;
2. If a partnership, the name of each partner, and the name of the partnership;
3. If a sole proprietorship, the full name of the sole proprietorship and the name of the business entity.
4. If a corporation, the name and title of each corporate officer and director, the corporate names and the name of the State of incorporation; and the name of the parent company, if any.
(f) Where operations are conducted at more than one location by a single prison clinic pharmacy, each such location shall be licensed by the Board.
(3) Administration of Applications for Licensure.
(a) Registration of a prison clinic pharmacy will be considered on the basis of the application filed with the Board, fee 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.
(b) Application fees shall not be refundable.
(c) Licenses become null and void upon the sale, transfer or change of mode of operation or location of the business.
(d) Licenses are renewed for two years 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 made and the fee paid before September 1st, of the odd numbered year, the license shall lapse and shall not be renewed. An application for reinstatement shall be required. Reinstatement shall be at the sole discretion of the Board.
(e) Changes in any information in this section shall be submitted to the Board prior to such change.
(4) Minimum Qualifications.
(a) The Board will consider the following factors in determining eligibility for licensure for person(s) in charge of the facility and are applying for a prison clinic pharmacy:
1. Any convictions of the applicant under any Federal, State, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;
2. Any felony convictions of the applicant under Federal, State, or local laws;
3. The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;
4. Suspension or revocation by Federal, State, or local government of any license currently or previously held by the applicant.
5. Compliance with licensing requirements under previously granted licenses, if any;
6. Compliance with requirements to maintain and/or make available to the State Licensing Authority or to Federal, State, or local law enforcement officials, those records required to be maintained prison clinic pharmacies; and
7. Other factors or qualifications the Board considered relevant to and consistent with the public health and safety. 8. 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 480-8-.03 Personnel

The personnel shall be as follows:

(a) Director. Each prison clinic 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 prison clinic pharmacies. The Director of Pharmacy shall be responsible for all activities of the prison clinic pharmacy, and for meeting the requirements of the Georgia Pharmacy Laws and Rules and Regulations of the Board of Pharmacy. The Director of Pharmacy shall work on a full-time or part-time basis, consistent with the needs of the institution.
(b) Supportive personnel. The Director of Pharmacy of a prison clinic pharmacy shall be assisted by a sufficient number of additional pharmacists and ancillary personnel in ratios consistent with state pharmacy laws and regulations, as may be required to operate such pharmacy competently, safely, and to meet the needs of the patients of the prison clinic facility.
1. The Director of Pharmacy shall insure that trained ancillary personnel shall be employed. The Director of Pharmacy shall develop and implement written policies and procedures to specify the duties to be performed by such ancillary personnel. These policies and procedures shall, at a minimum, specify that ancillary personnel are personally and directly supervised by a licensed pharmacist and are not assigned duties which may be performed only by licensed pharmacists.
2. Secretarial and clerical assistance and support shall be provided as required to assist with the 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 prison clinic pharmacy shall be personally and directly supervised by its Director of Pharmacy. All functions and activities of ancillary 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 prison clinic pharmacy.

Rule 480-8-.04 Absence of Pharmacist

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

(a) General. When a registered pharmacist is not physically present in the prison clinic pharmacy, 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 prison clinic by use of night cabinets and/or by access to the pharmacy.
(b) 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 prison clinic, develop inventory listings of those drugs to be included in such cabinet(s) and shall insure that:
1. Such drugs are available therein, properly labeled, with drug name, strength, lot number and expiration date;
2. Only prepackaged drugs are available therein, in amounts sufficient for immediate therapeutic requirements;
3. Whenever access to such cabinet(s) shall have been gained, written physician's orders and proofs 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 the subsection.
(c) Access to pharmacy. Whenever any drugs are not available from floor supplies of 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 physician's order and the requirements of this subsection. Only one designated, licensed medical staff member (R.N., L.P.N. or Clinic Associate) in any given 8-hour shift may have access to the pharmacy and may remove drugs from there. Such licensed medical personnel shall be designated in writing by the Director of Pharmacy of the prison clinic 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 Director of Pharmacy, who shall require, at a minimum, the following records and procedures:
1. Removal of any drug from the pharmacy by an authorized medical staff member must be recorded on a suitable form showing name of drug, strength, amount, date, time and signature of the authorized medical staff member.
2. The container from which the drug is removed shall be placed conspicuous location so as to be promptly reviewed and inspected by a pharmacist coming on duty.
(d) Emergency kits/crash carts. Drugs may be provided for use by authorized 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 in sufficient time to prevent risk or harm to patients;
2. Drugs included. The Director of Pharmacy and the medical staff of the prison clinic shall jointly determine the drugs, by identity and quantity to be included in emergency kits;
3. Storage. Emergency kits shall be stored in limited access areas and sealed to prevent unauthorized access, and to insure a proper environment for preservation of the drugs contained.
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 and proper documentatoin of such approval is maintained;
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 prison clinic to prevent misunderstanding or risk or harm to the patients;
6. Removal of drugs. Drugs shall be removed from emergency kits only pursuant to a valid physician's order, by authorized medical personnel, or by a pharmacist of the institutional facility;
7. Notification. Whenever an emergency kit is opened, the pharmacy shall be notified; and the pharmacy shall re-stock the kit within a reasonable time (no later than a Pharmacist's next visit to institution) so as to prevent risk or harm to patients. In the absence of a pharmacist, at least one emergency kit will be made available for exchange. 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 re-sealed.
9. Policies and Procedures. The director of Pharmacy shall, in conjunction with the medical staff of the prison 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 should also be readily available in areas outside the pharmacy where emergency kits are stored.

Rule 480-8-.05 Physical Requirements

Physical Requirements are as follows:

(a) Area. A prison clinic pharmacy shall have within the institution 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 prison clinic pharmacy space required shall be a minimum of 150 square feet. This includes all areas which are assigned and under the direct control of the Director of Pharmacy.
(b) Equipment and materials. Each prison clinic pharmacy shall have sufficient equipment and physical facilities for proper dispensing, and storage of drugs. The equipment and physical facilities shall include the following:
1. Dispensing area, including:
(i) Refrigerator in operating condition with a thermometer for monitoring the temperature;
(ii) Sink in working condition with both hot and cold running water;
(iii) Graduates of assorted sizes;
(iv) Two (2) spatulas and one (1) pill counting tray;
(v) Typewriter, word processor, or computer with label printer;
(vi) Class A or equivalent and assorted metric and apothecary weights if not electronic; and,
(vii) Such other equipment as deemed necessary by the Director of Pharmacy to support the scope of practice of the pharmacy.
2. Storage and receiving area;
3. Manufacturing and packaging area; and,
4. Office space area.
(c) Variances.
1. The Director of Pharmacy may submit to the Board a typed request for a variance to these provisions relating to minimum equipment requirements. Stated reasons for application for variances must be included in the submitted request. A variance shall be granted by the Board only when, in the judgement 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 Director of Pharmacy will be notified by the Board's decision in writing.
2. If approved, said letter(s) will serve as the proof of the Board's approval for variances indicated in the letter, and must be posted next to the Georgia Drugs and Narcotics Agency inspection report.
(d) Each prison clinic pharmacy shall maintain a reference library of, at a minimum, the following:
1. Copies of and/or computer/electronic access to, current reference materials appropriate to the individual pharmacy practice; The Georgia Pharmacy Practice Act; The Georgia Controlled Substances Act; and The Rules of the Georgia State Board of Pharmacy. These reference materials shall be authoritative on at least the topics of drug interactions; patient counseling; compounding and pharmaceutical calculations; and generic substitution;
2. Compability charts if IV solutions are being prepared in the pharmacy;
3. Current antidote information and the telephone number of a poison control center conspicuously displayed;
4. Other reference materials as may be determined by the Board to meet the current practice standards.
(e) Storage. All durgs shall be stored in designated areas within the prison clinic pharmacy which are sufficient to insure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security. Drug storage cabinets and unit dose carts in the medication area shall be locked when the said area is not in attendance by medical staff personnel.
(f) 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.
(g) Unattended areas. Whenever any area of a prison clinic pharmacy is not under the personal and direct supervision of authorized personnel, such areas shall be locked.
(h) Security. All areas occupied by a prison clinic pharmacy shall be capable of being locked by key or combination, so as to prevent access by unauthorized personnel. 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.

Rule 480-8-.06 Drug Distribution and Control

Drug Distribution and Control shall be as follows:

(a) General. A drug distribution system is the entirety of that mechanism by which a practitioner's prescription drug order is executed, from the time the prescriber transmits the order either orally or in writing to an authorized health professional through the time the ordered drug is administered to the patient or delivered to the patient for self-administration.
(b) Responsibility. The Director of Pharmacy shall be responsible for the safe and efficient distribution control, and accountability for drugs. The other professional staff of the prison clinic shall cooperate with the Director in meeting this responsibility and in ordering, administering, and accounting for the pharmaceutical materials so as to achieve this purpose. Accordingly the Director shall be responsible for, at a minimum, the following:
1. The drugs must be identified up to the point of administration;
2. The pharmacy must receive a direct copy or mechanical copy of a physician's order before the first dose of medication is dispensed except as defined by prison clinic stat order policy;
3. Utilization of a pharmacy-generated patient profile. This shall be the official record of medications dispensed to the patient. The patient profile shall be maintained under the control of the Director of Pharmacy for a period of two (2) years. The patient profile shall contain at a minimum:
(i) Given and last name;
(ii) DOC I.D. Number or any other assigned I.D. Number;
(iii) Date of birth;
(iv) Sex;
(v) Dorm or permanent housing assignment;
(vi) Drug product dispensed, date dispensed, strength, dosage form, quantity and directions, and identification of dispensing pharmacist;
(vii) Identification or differentiation of controlled substances;
(viii) Selected medical data; and
(ix) Sensitivities and allergies to drugs and foods.
4. Maintaining no more than a 7 day's supply of unit dose medication with prison clinic labeling or no more than a 30-day supply of maintenance medication with retail labeling.
5. Establishment of specifications or use of compendial specifications for procurement of drugs, chemicals, and biologicals, subject to approval of the appropriate committee of the prison clinic;
6. Participation in development of a drug formulary for the prison clinic;
7. Filling and labeling all containers from which drugs are to be administered, after visual screening to determine that same are neither adulterated nor misbranded;
8. 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 such other materials and information as may be deemed necessary shall also be maintained;
9. Records of all transactions of the prison clinic pharmacy as may be required by law, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials. Nothing in this section shall prohibit the use of computer hard copy, where such copy meets all other requirements of the law;
10. Participation in those aspects of the prison clinic patient care evaluation program which relate to pharmaceutical material utilization and effectiveness, and,
11. Efficient messenger and delivery service to connect the pharmacy with appropriate parts of the facility throughout the normal workday.
(c) Labeling. Labeling shall include:
1. For use inside the prison clinic, all drugs dispensed by a prison 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.
2. For use outside the prison clinic or institution, all drugs dispensed by a prison clinic pharmacy to inmates housed outside the prison clinic or those about to be released or on leave shall be labeled with the following information:
(i) Name, address and telephone number of the prison clinic pharmacy;
(ii) Date and identifying serial number;
(iii) Full name of patient;
(iv) Name of drug, (brand or generic) and strength;
(v) Directions for use to the patient;
(vi) Name of practitioner prescribing;
(vii) Require precautionary information regarding controlled substances; and,
(viii) Such other and further accessory cautionary information as may be required or desirable for proper use and safety to the patient.
(d) Discontinued drugs. The Director of Pharmacy 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 prison clinic pharmacy for proper disposition according to the following:
1. The following method of destruction of non-controlled substances is approved by the Board for medications dispensed to patients residing in a prison facility. When non-controlled drugs are expired, discontinued from use or the patient for whom they are ordered expires, the drugs shall be immediately removed from the active stock and inventoried by a pharmacist, along with another licensed healthcare professional or a corrections officer. The completed inventory shall be signed and dated by those two individuals. The original inventory shall be maintained by the facility for two years, and a copy shall be kept with the drugs until their final disposition. Once inventoried, these drugs can either be:
a. Placed in a secure storage area at the facility separated from edications with active orders. The drugs can 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 along with the inventory for two years. This record shall include at a minimum the date, time, personnel involved with the destruction and the method of destruction; or
b. The drugs for destruction are removed from the pharmacy by transfer to a reverse distributor with a current permit issued by the Board and a record of the following is maintained by the Prison Clinic for at least two years:
(1) 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;
(2) The date and time the drugs were taken from the pharmacy;
(3) The name, Board permit number, address and telephone number of the destruction firm removing the drugs;
(4) The name and signature of the responsible person representing the reverse distributor who is physically removing the drug(s);
(5) The name and signature of the Pharmacist representing the pharmacy transferring the drug(s) to the reverse distributor.
2. The following methods of destruction of controlled substances are approved by the Board of Pharmacy:
(a) A securely attached wooden or metal cabinet will be made available within a locked limited-access area. When controlled drugs are discontinued or the patient expires, the medication shall be pulled form the active stock immediately and inventoried and verified by a pharmacist along with another licensed healthcare professional or a correction officer. The inventory must be recorded into a permanent record and the drugs shall then be placed in the aforementioned cabinet. This medication would remain within the locked cabinet until such time that it is removed for destruction.
1. The pharmacist will establish a form, which shall include the following data:
i. Date of discontinuance or inventory date;
ii. Name of patient;
iii. Name of issuing pharmacy;
iv. Identifying serial numbers;
v. Name and strength of drug; and
vi. Quantities of drugs in containers when inventoried.
2. A licensed pharmacist must destroy the drugs in the presence of at least two witnesses.
3. 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 all three witnesses present at the destruction in the following format:

"We whose signatures appear below, certify that these controlled substances have been recondiled, accounted for, and destroyed at ___________________________(location) on __________________________ (date) ___________________o'clock.

Name of drug

Strength of drug

___________________________________________________________________

(Signature and Title)

___________________________________________________________________

(Signature and Title)

___________________________________________________________________

(Signature and Title)

4. The Board and/or the GDNA may prohibit any pharmacist or prison clinic facility from utilizing this method.
(b) 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 they are transferred. When the drugs are transferred to a reverse distributor licensed by the Georgia Board, an inventory including the names of the drugs, the dosage forms of the drugs and the quantities of drugs is taken and witnessed by an authorized representative of the prison clinic pharmacy and the responsible person representing the reverse distributor.
2. The prison clinic pharmacy must maintain a receipt/record with the following information: 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 prison clinic pharmacy for a minimum of two years.
(e) Prescription Drug orders. Drugs may be dispensed from the prison clinic pharmacy only upon written orders, direct or copies thereof, of authorized practitioners.
1. Authorization. The appropriate committee of the prison clinic shall, from time to time as appropriate, designate those practitioners who are authorized to issue prescription drug orders to the pharmacy.
2. 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 prison clinic.
3. Requirements--orders for drugs for use by inpatients. Orders for drugs for use by in-patients shall, at a minimum, contain:
(i) Patient name and dorm or permanent housing assignment;
(ii) Drug name, strength, directions for use; and
(iii) Date and physician's signature.
4. Requirements--orders for drugs for use by outpatients. Orders for drugs for use by outpatients shall at a minimum, contain all of the items required by Rule 480-8-.06(e)3., and in addition:
(i) Dispensing quantity; and
(ii) Practitioner's address and Drug Enforcement Administration permit number, if applicable.
(f) Accountability of Controlled Drugs--Proof of Use of controlled substances on standard ward inventory. Proof of use of controlled substances and such other drugs as may be specified by the appropriate committee of the prison clinic, shall be submitted to the pharmacy, on forms provided by the pharmacy.
1. Proof of use forms shall specify at a minimum:
(i) Name of drug, strength, and dosage form;
(ii) Dose;
(iii) Name of ordering physician. This shall include, at a minimum, the initial and last name;
(iv) Given and last name of inmate, DOC I.D. Number, or any other assigned I.D. Number;
(v) Date and time of administration to patient;
(vi) Signature of individual administering the drug, which shall include at a minimum, the initial, last name and title;
(vii) Documentation of destruction of all unused portions by two signature verifications of two licensed staff members;
(viii) Proof of receipt of medications that bears identifying serial numbers; and
(ix) Date the medication was issued and the date that the proof of use form was returned.
2. Use of computer hard copy is permitted where such copy meets all other requirements of the law.
3. Any prison clinic pharmacy licensed by the Board and in which controlled substances are administered to patients, may make on-premises destruction of small quantities of controlled substances prepared for oral administration provided:
(i) The controlled substance is the remainder of a single-dosage unit; and
(ii) The single-dosage unit from which the ordered dose prepared is the nearest possible size to the dose ordered.
4. Perpetual inventory of Schedule II controlled substances shall be required and accountability of said drugs shall be by proof of use form.
(g) Recall. The Director of Pharmacy shall develop and implement a recall procedure to assure that all drugs within the prison included on the recall are returned to the prison clinic pharmacy for proper disposition.
(h) Suspected adverse drug reactions. All suspected adverse drug reactions shall be reported immediately to the ordering physician, the pharmacy, and to the appropriate committee of the prison clinic. An appropriate entry on the patient's record shall also be made.
(i) Records and reports. The Director of Pharmacy 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 employees. These shall include, at a minimum, the following:
1. Patient profile;
2. Proof of use documents;
3. Reports of suspected adverse drug reactions;
4. Inventories of night cabinets and emergency kits/crash carts;
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 Rules and Regulations of the Board of Pharmacy.
(j) Standard ward inventory (floor stock). The pharmacy department may distribute drugs within a prison clinic 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 prison clinic or by an inventory replacement system. These drugs may be administered only pursuant to a physician's order. This physician's order will be forwarded to the pharmacy and these medications will be recorded on the pharmacy patient profile. A survey of usage trends of each standard ward inventory shall be made monthly. Such records shall be maintained for a period of two (2) years.

Rule 480-8-.07 Administration of Drugs

(a) General. The Director of Pharmacy may assist in the training of correctional personnel for assisting in the administration of medications. A record of satisfactory participation in the course is placed in the Correctional Officer's personnel file.
(b) Self-administration. The Director of Pharmacy shall assist in the development and implementation of policies and procedures concerning self-administration of medications.

Rule 480-8-.08 Drugs from Outside Sources

Drugs from outside sources shall include, but not be limited to, drugs brought to the facility by inmates. All such drugs shall be subject to all the rules and regulations promulgated by the Board. The Director of Pharmacy shall establish written policies and procedures relating to drugs brought into the institution. Administration shall be pursuant to an authorized practitioner's order only. If such drugs are not to be administered, the medication shall be destroyed by the Director of Pharmacy or qualified designee as required by law. 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 and documentation of approval is maintained.

Rule 480-8-.09 Inspection

Inspection shall include:

(a) Monthly. The Director of Pharmacy shall no less than once per month, personally or by qualified designee, inspect all matters within his jurisdiction and responsibility and make appropriate written records of such inspections. Such inspections shall, at a minimum, verify that:
1. Drugs are dispensed only by registered pharmacists;
2. Ancillary pharmacy personnel are properly directed and supervised;
3. Disinfectants and drugs for external use are stored separately and apart from drugs for internal use or injection;
4. Drugs requiring special storage conditions to insure their stability are properly stored;
5. No outdated drugs are stocked in the prison clinic pharmacy or the facility it serves;
6. Distribution and administration of controlled substances are properly and adequately documented and reported by both pharmacy and medical personnel;
7. Verification of standard ward inventory and medication accountability, including such up dating, if applicable, are maintained;
8. All necessary and required security and storage standards are met;
9. Measure conversion tables and charts are available;
10. All policies and procedures of the director and of appropriate committees of the prison clinic relevant to pharmacy are followed; and
11. All discontinued and out-dated medications are returned to the pharmacy for proper disposition.
(b) Board Inspection. The Board, by its qualified designee, shall regularly inspect all aspects of the management and operation of all prison clinic pharmacies in the State to verify compliance with the Law, these 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 prison clinic serviced by the pharmacy are protected. A written report shall be filed with the Board, the Director of Pharmacy, and the Prison Clinic Administrator. Any discrepancies or deficiencies noted shall be corrected within a reasonable time. Written notice of such corrective actions shall be filed with the Board of Pharmacy within thirty (30) days after receipt of the inspection report.
(c) Every registrant shall ensure that all controlled substances and/or dangerous drugs are purchased from and returned to firms licensed by the Georgia Board. This can be accomplished by maintaining a copy of those firms' current Georgia Board of Pharmacy permit.