Ga. Comp. R. & Regs. 480-24-.06

Current through Rules and Regulations filed through November 21, 2024
Rule 480-24-.06 - Destruction of Drugs
(1) The following methods of destruction of non-controlled substances are approved by the Board for medications dispensed to patients residing in long term care facilities (nursing home or skilled nursing facility) or other facility where a consultant pharmacist's services are required under state or federal regulations:
(a) When non-controlled drugs are expired, discontinued from use or the patient for whom they were ordered is no longer a patient, the drugs shall be immediately removed from the active stock and inventoried by two people who shall be licensed either as a pharmacists, a nurses, or a licensed practical nurses. The completed inventory record shall be signed and dated by these two individuals. The original inventory record 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:
1. Placed in a secure storage area at the facility separated from medications with active orders. The drugs can be destroyed at the facility by the consultant pharmacist and another pharmacist, nurse, or licensed practical nurse 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 record for two years. This record shall include at a minimum the date, time, personnel involved with the destruction and the method of destruction; or
2. Removed from the facility and kept by the consultant pharmacist until they are returned to the vendor pharmacist for destruction. The consultant pharmacist shall make a receipt for the drugs removed, and the original receipt to be kept by the facility and a copy of the receipt kept by the pharmacist. The receipt shall reflect: the date the drugs were removed from the facility, the name of the person removing the drugs, the name and address of the pharmacy to which the drugs have been removed. Both the receipt and its copy must be maintained for two years. Before any drugs can be removed for destruction, their inventory must be verified by at least one pharmacist and one other licensed health care practitioner. Once taken to the vendor pharmacy, the drugs must be stored in a secure, location, separate from active inventory, within the pharmacy. When the drugs are destroyed, a record of the manner of disposal of the drugs must be maintained by the vendor pharmacy for two years. The disposal record shall include at a minimum, whether:
(i) The drugs are destroyed at the pharmacy, and
(I) Manner of destruction;
(II) Date and time of destruction;
(III) Names of at least one pharmacist and one other licensed health care practitioner witnessing the destruction; or
(2) The drugs for destruction are removed from the pharmacy by transfer to a reverse distributor with a current permit issued by the Board; and
(I) The date and time the drugs were taken from the pharmacy;
(II) The name, Board permit number, address, and telephone number of the reverse distributor removing the drugs;
(III) The name and signature of the responsible person representing the reverse distributor physically removing the drugs;
(IV) The name and signature of the pharmacist transferring the drugs to the reverse distributor.
(2) The following methods of on-site destruction of controlled substances are approved by the Board:
(a) When controlled drugs are expired, discontinued from use or the patient for whom they are ordered is no longer a patient, the medication shall be removed from the active stock immediately and inventoried and verified by two people who shall be licensed either as a pharmacist, a nurse, or a licensed practical nurse. The completed inventory record shall be signed and dated by those two individuals. An inventory form will be established by the pharmacist, which must include the following data:
1. Date of discontinuance or inventory date;
2. Name of patient;
3. Name of issuing pharmacy;
4. Identifying serial numbers of the prescriptions;
5. Name and strength of drug; and
6. Quantities of drugs in containers when inventoried.
(b) After being removed from active stock, controlled substances to be destroyed must be placed in a secure cabinet or area as identified by the consultant or vendor pharmacist.
(c) On-site destruction can be as follows:
1. The consultant or vendor pharmacist will notify the GDNA as to the date and time the destruction will take place at least two weeks prior to destruction at the facility. (Please note that the consultant may set up a specific schedule of destruction - an example would be the first Tuesday in each month at 10:00 a.m.)
2. Three licensed professionals or law enforcement officers, one of whom must be a pharmacist, must witness the destruction of these drugs.
3. Destruction must take place within the facility.
4. Inventory of final destruction must be taken in duplicate, one copy shall be retained by the facility, and one copy shall be retained by the consultant pharmacist. 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 reconciled, accounted for, and destroyed at _______________(location) on _________(date) at ________o'clock."

___________________(Signature)

___________________(Signature)

___________________(Signature)

5. The Board and/or the GDNA, or the DEA, may prohibit any consultant pharmacist or facility from utilizing this method.
(3) Methods of off site destruction as follows:
(a) When controlled substances are expired, discontinued from use or the patient for whom they are ordered is no longer a patient, the medication shall be removed from the active stock immediately and inventoried and verified by two people who shall be licensed either as a pharmacist, a nurse, or a licensed practical nurse. The completed inventory record shall be signed and dated by those two individuals. An inventory form will be established by the pharmacist, which must include the following data:
1. Date of discontinuance or inventory date;
2. Full name of patient;
3. Name of issuing pharmacy;
4. Identifying serial numbers of the prescriptions;
5. Name and strength of drug; and
6. Quantities of drugs in containers when inventoried.
(b) After being removed from active stock, controlled substances to be destroyed must be placed in a secure cabinet or area as identified by the consultant or vendor pharmacist.
(c) The drugs, along with a copy of the permanent record, can then be transferred to the vendor pharmacy by the consultant pharmacist to hold for disposal by a Board licensed reverse drug distributor or by a GDNA Agent. The consultant pharmacist shall make a receipt for the drugs removed, and the original receipt is to be kept by the facility and a copy of the receipt kept by the consultant pharmacist, both for two years. The receipt shall reflect at a minimum:
1. The date the drugs were removed from the facility;
2. The name and signature of the consultant pharmacist removing the drugs;
3. The name and signature of the Director of Nursing witnessing the drug removal;
4. The name and address of the pharmacy to which the drugs are being removed.
(d) Once received by the pharmacy, the drugs for disposal must be stored in a secure location within the pharmacy. When disposal of the drugs takes place, a record of the disposal will be maintained by the pharmacy for two years. The type of disposal record shall be, either:
1. On a separate receipt showing the drugs for destruction were removed from the pharmacy by transfer to a Board licensed reverse distributor, showing:
(i) The date and time the drugs were taken from the pharmacy;
(ii) The name, address, telephone number and Board permit number of the reverse distribution firm taking possession of the drug;
(iii) The name and signature of the responsible person representing the reverse distributor firm and physically removing the drugs;
(iv) The name and signature of the pharmacy representative transferring possession of the drugs; and
(v) A copy of the permanent drug inventory destruction record from the facility; or
2. On the permanent record showing the drugs were destroyed by a GDNA Agent with:
(i) The signature of the GDNA Agent;
(ii) The signature of the pharmacy manager as listed on the pharmacy license; and
(iii) The date and time of the drug destruction.

Ga. Comp. R. & Regs. R. 480-24-.06

O.C.G.A. Secs. 16-13-34, 16-13-35, 16-13-39, 16-13-72, 26-4-27, 26-4-28, 26-4-110, 26-4-113, 26-4-115.

Original Rule entitled "Destruction of Drugs" was filed on May 5, 1980; effective May 25, 1980.
Amended: Rule repealed and a new Rule of the same title adopted. Filed February 15, 1983; effective March 7, 1983.
Repealed: New Rule of same title adopted. F. Jun. 14, 1989; eff. July 4, 1989.
Amended: F. May 21, 1997; eff. June 10, 1997.
Amended: F. Aug. 17, 1998; eff. Sept. 6, 1998.
Repealed: New Rule of same title adopted. F. Feb. 25, 2002; eff. Mar. 17, 2002.