All hospital pharmacies shall renew --------of each -----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.

biennially by June 30th

odd-numbered year

When a licensed pharmacist is not physically present in the hospital and the pharmacy is -----, 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 ----- and/or by access to the pharmacy. The policies and procedures may include the use of -----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.

closed

night cabinets

remote order entry pharmacist

when is A hospital pharmacy shall be authorized to utilize remote order entry when. Select 3 choices

• 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
• When at least one licensed pharmacist is physically present in the hospital
• 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.

The remote entry pharmacist shall maintain records of any and all records entered for the hospital for a minimum of ----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

two (2)

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.

night cabinets

Night cabinets: Only ------ drugs ( hint packaged or pre packaged?) are available therein, in amounts sufficient for immediate therapeutic requirements

All drugs therein are inventoried no less than ------per week.

pre-packaged

once

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,what can be done?

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.

When a nurse accesses drugs directly from the closed pharmacy, the nurse must:

• provide a copy of the order,
• 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.
• 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.

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;

Emergency kit/crash cart drugs defined.

how are emergency kits stored

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;

how are emergency kits labeled 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;

how are emergency kits labeled 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

Each emergency kit/crash cart shall be opened and its contents inspected by a pharmacist at least once every ------days. Upon completion of inspection, the emergency kit/crash cart shall be re-sealed;

ninety (90)

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 ------ per hospital bed, which includes all areas assigned and under the direct control of the Director of Pharmacy.

10 square feet

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 given and last name;

4.Name of drug, (brand or generic) and strength;

5.Directions for use by patient;

6.Name of the 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.

Destruction of controlled substances:

Any portions of controlled substances discontinued and taken from a medication delivery device shall be destroyed by a----- or a ------and ----- 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.

licensed pharmacist, licensed nurse , one witness.

discontinued non-controlled substances dispensed to hospital patients shall be returned to the pharmacy and evaluated by the ----- to assure the integrity of the medication.

licensed pharmacist

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 -----years

2

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, what should happen?

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

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.

drugs from outside sources:

Such drugs shall not be administered unless they can be precisely identified.

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, can they be stored in pt room?

may not be stored on the patient care unit.

Inspections is conducted --------.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

monthly

The Board of Pharmacy inspections shall be conducted by representatives of the Georgia Drugs and Narcotics Agency (GDNA) no less than once every ----- years.

two (2)

chapter 14: DRUGS AND NARCOTICS AGENCY CLASSIFICATIONS AND MINIMUM REQUIREMENTS FOR SPECIAL AGENTS AND DEPUTY DIRECTOR

ch 14

A GDNA Special Agent shall be a graduate of a recognized school or college of pharmacy and hold a current pharmacist license issued by the Georgia State Board of Pharmacy (Board). Additionally, to qualify as a GDNA Special Agent, the applicant shall have

Actively practiced pharmacy for at least two (2) years

chapter 15 PHARMACY TECHNICIANS AND OTHER PHARMACY PERSONNEL

15

a registered pharmacy technician who has either successfully passed a certification program approved by the Board, or has successfully passed an employer's training and assessment program approved by the Board, or has been certified by either the Pharmacy Technician Certification Board (PTCB) or any other nationally recognized certifying body approved by the Boar

Certified pharmacy technician

In order to be registered as a Pharmacy Technician in this State, an applicant shall:

(a)Submit an application to the Board on the form prescribed by the Board;(b)Attest that applicant is at least 17 years old;

(c)Attest that applicant is currently enrolled in high school, or has a high school diploma, or has a GED, or has a postsecondary education or college degree

(d)Consent to, provide the necessary information to conduct, and pay for a background check to be conducted by the Board, i

e)Submit the name and address of employer and place of employment;

(f)Pay application fees; and

(g)If certified, submit evidence of training supporting designation as certified.

On and after July 1, 2023, as a requirement for the biennial renewal of his/her registration, a pharmacy technician must complete not less than----- hours of approved continuing education.

twenty (20)

"Approved continuing education" means courses approved by the Board

The pharmacist to registered pharmacy technician ratio shall not exceed one pharmacist providing direct supervision of four registered pharmacy technicians in accordance with the certification requirements below

.1.Any time during which a pharmacist is directly supervising ---or---- technicians, no certification is required.

2.Any time during which a pharmacist is directly supervising ---- technicians, at least --- must be certified

3.Any time during which a pharmacist is directly supervising---- technicians, at least two must be certified

.(i)Have successfully passed a certification program approved by the Board of Pharmacy;(ii)Have successfully passed an employer's training and assessment program which has been approved by the Board of Pharmacy; or(iii)Have been certified by the Pharmacy Technician Certification Board.

one or two

three, one

four,two

In addition to the utilization of ----registered pharmacy technicians as outlined in subsection (e), a pharmacist may be assisted by and directly supervise at the same time one (1) pharmacy intern, one (1) pharmacy extern, and one (1) pharmacy observer.

four (4)

Duties or Functions Prohibited from Being Performed by a Registered Pharmacy Technician: prohibited or not questions as followed below

p

Acceptance of telephoned or other oral prescriptions

prohibited

Transfers of prescription drug orders from another pharmacy or transfers of a prescription drug order to another pharmacy

prohibited

Patient counseling

prohibited

Receiving information or providing information about a prescription drug order

prohibited

Making the determination as to whether to refill the prescription drug order

prohibited

Certification of a filled and finished prescription drug order

prohibited

Weighing or measuring active ingredients without a mechanism of verification

prohibited

Compounding of medication without a mechanism of verification;

prohibited

Giving a completed prescription to the patient requesting same without the label and contents and the label being verified by a pharmacist.

prohibited

Reconstitution of prefabricated medication without a mechanism of verification

prohibited

Verification of the constituents of final IV admixtures for accuracy, efficacy, and patient utilization

prohibited

Enter of order on patient medication profiles without verification by a pharmacist

prohibited

Provision of drug information that has not been prepared or approved by the pharmacist

prohibited

Review of the patient record for therapeutic appropriateness

prohibited

chapter 16 MISCELLANEOUS GUIDELINES FOR PHARMACISTS

MISCELLANEOUS GUIDELINES FOR PHARMACISTS

Any pharmacist having knowledge that a pharmacist or drug store owner allows or encourages any unlicensed person to illegally fill prescriptions or practice pharmacy while impaired shall report such action within------ days to the Director of the Georgia Drugs and Narcotics Agency (GDNA) and upon his failure to report such acts to the director, which shall be grounds for sanctions on such licensed person's license.

ten (10) days

It shall be unlawful, and a violation of these rules, for any licensed pharmacist or pharmacy licensed under O.C.G.A. 26-4 to accept for refund purposes, or otherwise, any unused portion of a drug which has been previously dispensed via a prescription drug order and delivered to the patient or patient's caregiver, except ----

where permitted under state and/or federal law or regulation.

Such receipt is deemed detrimental to the public health due to the likelihood that such drugs, once out of the control of the pharmacy, could have been tampered with, been adulterated, or become contaminated with communicable diseases and/or contagious diseases under the holder thereof

Nothing in this Rule shall be meant to be in conflict with Board Rule 480-10-. 17, which allow a pharmacy to receive unused, manufacturer's unit-dose packaged drugs from a Medicaid patient residing in a long term care facility. rule 480:10-17 says:

A pharmacist or pharmacy may receive eligible drugs for credit or reuse from long-term care facilities provided that:(

a)The drugs were originally dispensed by that pharmacist or pharmacy to the facility;

(b)The pharmacist has assurance from a person in responsible charge of the drugs at the facility that the drugs have been stored in accordance with the manufacturer's recommendations and USP standards;

(c)The drugs are still in the manufacturer's packaging with the expiration date and lot number and the integrity of the product and package have been maintained;

(d)The drugs are not expired and have a minimum of six (6) months remaining on the expiration date; and(e)Under the pharmacist's professional judgment the drugs are appropriate for return and reuse.

Within ----days following any damage by fire and/or water to a building or storage area in which any of the above said items are stored or retained, written notice shall be forwarded to the Director of the Georgia Drugs and Narcotics Agency (GDNA) at his office, by the person or his agent with custody or control of the said items informing the Director of the GDNA of the circumstances and requesting an immediate inspection of said items.

three (3)

The theft, loss, or the discovery of unaccounted for controlled substances, within ---- days of its discovery, must be reported to the GDNA

three (3)

A written report must be made regarding any theft or significant loss, as defined under 21 C.F.R. 1301.76, of controlled substances by completing a DEA Form ---- and submitted to the Drug Enforcement Administration, with a copy to the GDNA.

106

The report shall include the following information:

(a)Full name and address of the pharmacy;

(b)Pharmacy DEA registration number;

(c)Date of theft, loss, or discovery of missing controlled substance;

(d)Type of incident, i.e. theft, loss, etc.;

(e)List of cost codes, or identification symbols on package stolen; and

(f)List of the controlled substances missing.

skipped chapter 17,18

• 17:ISSUANCE OF INTRAVENOUS MAINTENANCE DRUGS TO REGISTERED PROFESSIONAL NURSES EMPLOYED OR CONTRACTED BY A HOME HEALTH AGENCY
• 18:OPIOID TREATMENT PROGRAM CLINIC PHARMACIES

A licensed pharmacist, or intern acting under the immediate and direct supervision of a licensed pharmacist, may sell, dispense or otherwise dispose of without prescription not more than-----dosage units of an exempted non-pseudoephedrine Schedule V controlled substance within any ---hour period of time, but only:

4 oz. or 32

48

No person shall obtain or attempt to obtain, in any 48-hour period of time, more than -------dosage units of a Schedule V controlled substance.

4 oz. or 32

Before the sale of any non-pseudoephedrine Schedule V Controlled Substance without a prescription, a licensed pharmacist should first determine whether or not the product to be sold is packaged in a container with not more than 4 ounces or 32 dosage units of the drug, and whether the label provided by the product manufacturer contains a Federal Caution or Warning.

If such Legend or Warning or Rx Only indication is present on the manufacturer's label, this product cannot be sold without a prescription.

A registered pharmacist or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist may sell, dispense or otherwise dispose of without prescription not more than ----grams every 24 hours, or a maximum of ------ grams every 30 days, to each customer of a pseudoephedrine containing drug product, but only

3.6

9

After applying reasonable means or effort to determine that such is to be used for legitimate medical purposes, following the proper record keeping procedures, and ensuring the required information has been properly recorded in a logbook which contains either a written or electronic list of sales.

For electronic logbooks used to record patient information for the sale of an exempt Schedule V pseudoephedrine containing

The patient must sign the logbook to acknowledge the sale and receipt of the pseudoephedrine containing drug product.

A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist, must approve all such sales or transactions.

All logbooks must be retained for a minimum period of ---- years from the date of the last recorded sale.

2

Any drug product containing pseudoephedrine which comes in a container packaged by the its manufacturer with and its label contains a Federal Caution or Rx Only indication, this product is not an exempt narcotic under this rule and cannot be sold as an ----drug product and can only be dispensed by a pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist upon receipt of a prescription issued by a licensed practitioner.

Exempt OTC Schedule V

chapter 21 RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES

FINISH UP

RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES

Each retail pharmacy providing home health care services shall have a designated area for preparing compounded, sterile parenteral products. This area shall be physically separate from other areas and should be designed to avoid unnecessary traffic and airflow disturbances. The minimum space shall be ---- square feet. It shall be used only for the preparation of specialty products. It shall be of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.

150

22 REQUIREMENTS OF A PRESCRIPTION UNDER ORDER

22 REQUIREMENTS OF A PRESCRIPTION UNDER ORDER

A hard copy prescription drug order for any Schedule ____ controlled substance must be on security paper.

2

If a hard copy of an electronic data prescription drug order for any Schedule II controlled substance is given directly to the patient, the manually signed order must be on security paper

Practitioners not registered with the DEA, but affiliated with hospitals or other institutions, shall include

the registration number of the hospital or other institutions as well as the special internal code assigned to the authorized practitioner by the hospital or other institution,

can a C-II prescription drug order, meeting the requirements of be transmitted by the practitioner or the practitioner's agent, to a pharmacy via facsimile machine or equipment?

yes

Prior to the practitioner's agent transmitting such schedule II (C-II) prescription via facsimile machine, the C-II prescription drug order, meeting the requirements of may be transmitted by the practitioner or the practitioner's agent, but not the -----or -------agent, to a pharmacy via facsimile machine or equipment

patient or patient's

Upon dispensing a schedule II (C-II) drug, the pharmacist shall physically sign his or her name on either the face or rear of the schedule II (C-II) prescription drug order in such a manner that the signature does not cover any information required by this chapter. I

In addition, the pharmacist will ensure that the dispensing date and the serial number for the prescription drug order are indicated on either the face or the back of the C-II prescription drug order.

pharmacist may dispense a schedule II (C-II) controlled substance only upon receiving oral authorization of the prescribing practitioner given what conditions:

• The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period
• The prescription drug order shall be immediately reduced to writing by the pharmacist or pharmacy intern/extern working under the direct supervision of a licensed pharmacist and shall contain all information required in Rule 480-22-.03, except for the signature of the prescribing practitioner
• Within 7 days after authorizing an emergency oral prescription drug order, the prescribing practitioner shall cause a written prescription drug order to be delivered to the dispensing pharmacist for the emergency quantity prescribed.
• If the prescribing practitioner is not known to the pharmacist, the pharmacist must make reasonable effort to determine that the oral authorization came from a licensed practitioner, such effort may include a callback to the prescribing individual using his or her telephone number and/or other good faith efforts to insure the practitioner's identity; and

In C2 emergency prescriptions what should pharmacist do if pharmacist doesnt know the provider or prescriber?

If the prescribing practitioner is not known to the pharmacist, the pharmacist must make reasonable effort to determine that the oral authorization came from a licensed practitioner, such effort may include a callback to the prescribing individual using his or her telephone number and/or other good faith efforts to insure the practitioner's identity;

A prescription drug order for a terminally ill patient, prepared in accordance with Rule 480- 22-.03 written for a Schedule II Controlled Substance as defined by O.C.G.A. § 16-13-26, may be transmitted in what means?

directly by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile machine.

terminal ill pt: Prior to the prescribing practitioner's agent transmitting such Schedule II Controlled Substance prescription via facsimile machine,------ and _______for the prescribing practitioner must be included in the face of prescription. The information may be used for verification of the prescription

the name of the agent and a telephone number

LTCF: A prescription drug order prepared in accordance with Rule 480-22-.04 written for any C-II substance for a resident of Long Term Care Facility (LTCF) may be transmitted directly by the prescribing practitioner or the practitioner's agent, but not the patient or the patient's agent, to the dispensing pharmacy by facsimile machine or equipment.

true

The practitioner, practitioner's agent, or pharmacist will note on the prescription drug order that the patient is a LTCF patient by writing ---- on the face of the prescription

"LTCF"

In addition to the term LTCF being noted on the face of the prescription, whenever a practitioner's agent transmits or a pharmacist receives such a prescription, -----,-------,-------must be included on the face of the prescription. This information may be used for verification of the prescription drug order.

the name of the agent and the practitioner's telephone number or the name and license number of the pharmacist

CIIs After transmission of the original prescription, the pharmacist should suggest that the practitioner mark "----across the face of the prescription, and that it be maintained by the practitioner in the patient's medical record

VOID

The practitioner or practitioner's agent will note on the prescription drug order that the patient is a hospice patient by writing -----on the face of the prescription.

"HOSPICE"

Whenever a pharmacist receives a prescription for a C-II controlled substance, and either the quantity of the drug to be dispensed or the strength of the drug to be dispensed has not been included by the prescribing practitioner, or when the strength of the prescribed drug is not immediately available, in order to dispense this drug, the pharmacist must perform the following:

Contact and speak directly with the practitioner, not with an agent for the practitioner, and inform the practitioner of the missing information on the face of the prescription, or the problem with the prescription in question by:

When contacting the practionioner determine what three things:

Determining the quantity of the drug the practitioner intended to be dispensed; or

2.Determining the strength of the drug the practitioner intended to be dispensed; or

3.Informing the practitioner the drug in the strength prescribed is not immediately available, but another strength of the prescribed drug is available.

Regarding the information provided by the practitioner, the pharmacist must write the missing quantity, the missing strength, or the changed quantity and strength of the prescribed drug on the face of the prescription along with the-------

the initials of the pharmacist.

On the back of the prescription, the pharmacist must write the date and time the pharmacist spoke with the practitioner, along with a brief explanation of the situation and how it was resolved.

The refilling of a prescription for a schedule------controlled substance is prohibited.

II (C-II)

is The partial filling of a schedule II (C-II) prescription drug order permissible?

yes

if the pharmacist is unable to supply the full quantity prescribed in a written or emergency oral prescription drug order, and the pharmacist makes a notation on the face of the written prescription drug order of the quantity supplied (dispensed).

the remaining portion of the prescription drug order may be filled within ---- hours of the first partial filling.

72

After this 72 hour period, the remaining quantity shall not be dispensed, thereby causing the remaining quantity to be void. No additional quantity may be dispensed without receipt of a new prescription drug order.

A prescription drug order for a schedule II (C-II) controlled substance written for a patient in a Long Term Care Facility (LTCF), a hospice patient, or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities.

true

The pharmacist must record on the prescription drug order whether the patient is "terminally ill", a "hospice patient", or a "LTCF patient

A prescription drug order may not be partially filled unless it contains the notation "terminally ill","hospice patient", or "LTCF patient", or it shall be deemed an unlawful prescription drug order.

No partial fill for any one except ?

A prescription drug order may not be partially filled unless it contains the notation "terminally ill","hospice patient", or "LTCF patient", or it shall be deemed an unlawful prescription drug order.

For each partial filling, the dispensing pharmacist shall record on the back of the prescription drug order (or on another appropriate record, uniformly maintained, and readily retrievable)

the date of the partial filling,

,,quantity dispensed

remaining quantity authorized to be dispensed, and

the identification of the dispensing pharmacist.

The total quantity of a schedule II (C-II) controlled substance dispensed in all partial fillings may not exceed the total quantity prescribed. Such C-II prescription drug orders may be partially filled for a period not to exceed ----days from the dispensing date or sooner if the medication is discontinued.

60

Upon dispensing a C-III, IV, or V controlled substance, the dispensing pharmacist shall ensure that his or her initials, the dispensing date, and the prescription serial number appear on the face of or the rear of each such prescription. Nothing shall prohibit the use of a computer-generated label to fulfill the requirements of this paragraph and/or the requirements of this Rule

All such information shall be placed on the prescription drug order in such a manner that it does not cover or veil any information required by this chapter or any other rule or law to appear on such prescription.

Prescription drug orders for schedule C-III, IV, or V controlled substances shall be maintained either in a separate prescription drug order file for such C-III, IV, or V drug orders only or in such a form that they are readily retrievable from the other prescription drug orders of the pharmacy.

A prescription drug order will be deemed readily retrievable if, at the time it is initially filled, the face of the prescription drug order is stamped in red ink in the lower right corner with the letter "C" no less than 1 inch high and filed in the usual consecutively numbered prescription drug order file for dangerous drugs; or

A pharmacy which utilizes a computerized record keeping system for prescription drug orders which permits identification of prescription drug orders by serial number and retrieval of documents by prescriber's name, patient's name, drug dispensed, and date filled, then there is no requirement to mark hard copy prescriptions with a red "C".

No prescription drug order for a C-III, IV, or V controlled substance shall be filled or refilled more than----- months after the date on which such prescription drug order was issued by the prescribing practitioner and no such prescription drug order may be authorized to be refilled for the quantity prescribed more than -----

6

five (5) times.

Nothing shall prohibit the refilling of such a prescription drug order in amounts less than the quantity prescribed as long as the total number of dosage units authorized for dispensing both the original quantity plus the refill quantities does not exceed six (6) months.

The date of each refilling of a prescription drug order shall be entered on the back of the prescription drug order or in a computerized record system, with which all documents must be uniformly maintained and readily retrievable.

t

The prescribing practitioner may authorize additional refills of the original C-III, IV or V controlled substance prescription drug order through an oral refill authorization transmitted directly to the pharmacist or pharmacy intern/extern working under the direct supervision of a licensed pharmacist provided the following conditions are met

If the pharmacist initials and dates the back of the prescription drug order, it shall be deemed that the full face amount of the prescription has been dispensed. If an amount other than the full face amount is dispensed, the quantity shall be noted next to the initials of the pharmacist.

If the authorization comes from a practitioner that is not the original prescriber, what should happen

the authorization shall be treated as a new prescription drug order authorized by the new prescribing practitioner.

An automated data processing (ADP) or computerized system may be used for the storage and retrieval of refill information for prescription drug orders for C-III, IV or V substances,

t

The partial filling of a C-III, IV, or V prescription drug order is permissible, subject to the following requirements:

a)Each partial filling is recorded in the same manner as a refill;

(b)The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and

(c)No dispensing occurs six (6) months after the date on which the prescription drug order was issued.

A pharmacist filling a prescription drug order for a C-II, III, IV or V substance shall affix to the package a label showing the following:

(a)The name, address and telephone number of the pharmacy;

(b)The prescription drug order serial number;

(c)The date the prescription was initially filled or refilled;

(d)The name of the patient;

(e)The name of the prescribing practitioner;(

f)The directions for use;

(g)The expiration date of the dispensed drug; and

(h)Cautionary statements, if any, as required.

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

one

However, pharmacies electronically sharing a real-time, online computerized database may transfer the prescription drug order information as many times as there are authorized refills, up to the maximum of -----times, if it is within------months from the date of issuance.

five (5)

six (6)

The transferring pharmacist or pharmacy intern/extern shall record the following information in either real time or at the first opportunity after the transfer:

1.The word "VOID" must be written on the face of the original, hard copy, invalidated prescription drug order;

2.The following must be written on the back of the original, invalidated prescription drug order: the name, address, telephone number, and DEA number of the pharmacy to which it is transferred, and the name of the pharmacist receiving the prescription information; and

3.The date of the transfer and the name of the pharmacist transferring the information must be recorded on the back of the prescription drug order.

The pharmacist or pharmacy intern/extern receiving the transferred prescription drug order information shall reduce it to writing and record the following information:

1.The word "TRANSFER" shall be written on the face of the transferred prescription drug order hard-copy;2.All information required to be recorded on a prescript ion drug order pursuant to this chapter, which shall include:(i)Date the prescription drug order was originally issued by the prescribing practitioner;(ii)The number of refills authorized on the original prescription drug order.

a physician assistant (PA) licensed by the Georgia Composite Medical Board is permitted to issue a prescription drug order or orders for any dangerous drugs, as defined in O.C.G.A. § 16-13-71, or for any Schedule ----,-----,-----Controlled substance without the co-signature of a supervising physician under the following conditions:

III, IV, or V

If the prescription is a hard-copy of an electronic visual image prescription drug order given directly to the patient or his/her agent, the hard copy must be printed on security paper with the wording that indicates the signature was electronically generated.

The supervising physician has delegated the authority to prescribe dangerous drugs and/or controlled substances in the PA's job description on file with the Georgia Composite Medical Board.

If the prescription is for controlled substances, the PA has a DEA number.

A physician assistant

No prescription drug order issued by a PA can be used to authorize refills more than------ months past the date of the original drug order.

twelve (12)

The prescription drug order must include the following:

(i)The name, address, and telephone number of the supervising physician and the PA;

(ii)The patient's name and address;

(iii)The drug name, strength and quantity prescribed;

(iv)The directions to the patient with regard to taking the drug;

(v)The number of authorized refills, if any; and

(vi)If applicable, the DEA permit number of the PA.

t

If the prescription is transmitted by facsimile or computer, the prescription shall include:

(i)The complete name and address of the supervising physician and the PA;

(ii)In the case of a prescription drug order for a controlled substance, the DEA registration number of the PA;

(iii)The telephone number of the PA for verbal confirmation;

(iv)The name and address of the patient;

(v)The time and date of the transmission;

(vi)The full name of the person transmitting the order;

(vii)The drug name, strength and quantity prescribed;

(viii)The directions to the patient with regard to taking the drug;(ix)The number of authorized refills, if any; and(x)The signature of the PA as provided in Rule 480-27-.02(2) or, in the case of a controlled substances prescription, in accordance with 21 C.F.R. 1301.22.

t

An advanced practice registered nurse (APRN) who is recognized by the Georgia Board of Nursing as having met the requirements to engage in advanced nursing practice, and whose registered nurse license and advanced practice registered nurse license are in good standing with the Georgia Board of Nursing, is permitted to issue a prescription drug order or orders for any dangerous drugs, O.C.G.A. § 16-13-71except for drugs intended to cause an abortion to occur pharmacologically, or for any Schedule---,----,-----controlled substance without the co-signature of a delegating physician under the following conditions:

III, IV, or V

The APRN has been delegated the authority to issue prescription for the dangerous drugs and controlled substances by a physician licensed by the Georgia Composite Medical Board in a nurse protocol agreement and that agreement has been filed with the Georgia Composite Medical Board.

If the prescription is for controlled substances, the APRN has a DEA number

If the prescription is a hard-copy of an electronic visual image prescription drug order given directly to the patient or his/her agent, the hard copy must be printed on security paper with the wording that indicates the signature was electronically generated

o prescription drug order issued by an APRN can be used to authorize refills more than -------months past the date of the original drug order unless the prescription drug order is for --------

twelve (12)

oral contraceptives, hormone replacement, or prenatal vitamins. Oral contraceptives, hormone replacement and prenatal vitamins may be refilled up to twenty-four (24) months from the date of the original drug order.

A pharmacist shall presume that a prescription drug order issued by a PA or APRN was issued by a PA or APRN duly licensed and qualified under Title 43, Chapter 34 to prescribe pharmaceutical agents.

A pharmacist shall presume that the drug prescribed by the PA is a drug approved by the supervising physician in the PA's job description and that the drug prescribed by an APRN is a drug authorized by the delegating physician in the APRN's nurse protocol agreement, unless the pharmacist has actual or constructive knowledge to the contrary.

Any practitioner receiving, maintaining, and dispensing professional drug samples shall maintain records of all drug samples requested and received, along with a complete list of the specific number and dosage of each professional drug sample and medication dispensed by the practitioner and the person to whom the drug samples were dispensed; Such records must be maintained for a minimum of two years by the practitioner at each facility or office location where professional drug samples are received, maintained, and dispensed.

In addition to the requirements of this rule, practitioners shall maintain all professional drug samples as required by all applicable state and federal laws and regulations.

Ophthalmic topical products may be refilled without authorization from a practitioner to prevent unintended interruptions in drug therapy provided that:

(1)The original prescription order contains valid refills;

(2)Refills occur at ----percent or greater of the predicted days of use; and

(3)Refills are purchased through retail and/or mail order pharmacies.

70