Ga. Comp. R. & Regs. 480-50-.03

Current through Rules and Regulations filed through November 21, 2024
Rule 480-50-.03 - Collection Receptacles Located at Long Term Care Facilities (LTCF)
(1) Collection receptacles in long-term care facilities ("LTCF") must be located in a secured area monitored by long-term care facility employees. Collection receptacles can only be used in facilities where a consultant pharmacist's services are required.
(a) A LTCF may only begin receiving drugs for disposal at the facility after providing thirty (30) days of advance notification to the Board and the Georgia Drugs and Narcotics Agency of its qualification for and intention to set up a collection receptacle.
(2) A LTCF may dispose of drugs on behalf of an ultimate user who resides, or has resided, at such LTCF by transferring those drugs into an authorized collection receptacle located at such LTCF. When using this method of destruction, the drugs must be transferred into the collection receptacle within three (3) business days after discontinuation of use by the ultimate user. This provision applied to drugs that are expired, discontinued from use, or when the patient for whom they were ordered is no longer a patient.
(3) When the 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 by one supervisor-level employee, and a copy shall be kept with the drugs until their final disposition. Once inventoried, these drugs must be placed in a collection receptacle at the facility containing a numbered secure Inner-liner which has been provided by an authorized collector (retail pharmacy).
(a) If the numbered inner-liner becomes full prior to collection by a reverse distributor, one supervisor-level employee of the LTCF (e.g., charge nurse or supervisor) and one authorized employee designated by the authorized collector or two authorized employees of the authorized collector pharmacy may change the collection receptacle inner-liner. Upon removal, sealed inner-liners may be stored at the LTCF for up to three (3) business days in a securely locked, substantially constructed cabinet or a securely locked room with controlled access.
(4) The drugs placed in the authorized receptacle and stored in secure inner-liner and those secured inner-liners stored by the LTCF can only be removed from the LTCF for disposal for destruction by transfer to a representative for a reverse distributor with a current permit issued by the Board and authorized by the DEA as a collector.
(a) The date and time that the numbered inner-liners were taken from the facility and the numbers of the inner-liners recorded in logs, one maintained by the facility for two years and one maintained by the reverse distributor for each facility for two years;
(b) The name, Board permit/license number, address, and telephone number of the reverse distributor removing the drugs;
(c) The name and signature of the responsible person representing the reverse distributor physically removing the Inner-liners; and
(d) The name and signature of the persons transferring the drugs Inner-liners to the reverse distributor.
(5) Authorized collectors may not transfer sealed inner-liners from LTCFs to their primary registered location (i.e., the hospital/clinic or retail pharmacy location). Instead, collectors should deliver sealed inner-liners to a reverse distributor or distributor's registered location by common or contract carrier pick-up or by reverse distributor or distributor pick-up at the LTCF.

Ga. Comp. R. & Regs. R. 480-50-.03

O.C.G.A. §§ 16-13-45, 26-3-7, 26-3-16, 26-4-27, 26-4-28, 26-4-29, 26-4-87, 26-4-112, Pub. L. 111-273.

Original Rule entitled "Collection Receptacles Located at Long Term Care Facilities (LTCF)" adopted. F. Jan. 20, 2016; eff. Feb. 9, 2016.