Chapter 480-50 DRUG DISPOSAL AND AUTHORIZED COLLECTORS
Rule 480-50-.01 Definitions
| (1) | "Authorized Collectors" or "Collectors" means retail pharmacies, hospitals/clinics with an on-site pharmacy, narcotic treatment programs, manufacturers, distributors, and reverse distributors which have registered with the DEA to become authorized collectors of drugs for disposal, are authorized to handle controlled substances, and are currently licensed by the Georgia Board of Pharmacy. |
| (2) | "Authorized Employees" means employees of authorized collectors that have met the DEA employment standards and are pharmacists licensed by the Georgia Board of Pharmacy. |
| (3) | "Collection Receptacle" means a lockable and sturdy container with a permanent outer container and a removable numbered inner-liner with a small opening that allows contents to be added but not removed and which container is securely fastened to a permanent structure in a secure area. |
| (4) | "Drugs" means controlled substances and dangerous drugs (non-controlled substances) as those terms are defined in O.C.G.A. Title 16, Chapter 13. |
| (5) | "Mail-back Packages" means pre-paid postage packages provided by authorized collectors at a price or at no cost to the patient or patient's family |
| (6) | "Mail-back Programs" means programs that utilize mail-back packages provided by authorized collectors in which the packages are mailed directly to a reverse distributor and can never be mailed back to the authorized collector. |
| (7) | "Numbered Inner-liner" means a removable, tamper-evident, and tear-resistant liner that bears a unique identification number that is used inside a collection receptacle and which can be securely sealed for transfer to a reverse distributor for transportation to a drug destruction site. |
| (8) | "Ultimate user" means a person who has lawfully obtained and who possesses a drug for his/her own use or for the use of a member of his/her household or for an animal owned by him/her or a member of his/her household. |
| (9) | "Unique Identification Number" means a number traceable to a specific authorized collector. |
Rule 480-50-.02 Collection Receptacles Located at Authorized Collectors
| (1) | Authorized collectors may place, utilize,
and maintain collection receptacles at their DEA registered location.
Receptacles can only be available to receive drugs when the collector is open
for business and only when an authorized employee is present.
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| (2) | Collection receptacles must be lockable, sturdy, securely fixed within the collector's location. If the authorized collector is in a pharmacy, then the collection receptacle must be in the immediate vicinity of and can be observed from the prescription department areas where controlled substances are stored by registrants and where an authorized employee is present, and display a sign stating that non-controlled and controlled drugs in Schedule II, III, IV, or V can be accepted and placed in the receptacle. If the collection receptacle is in a hospital/clinic, it must be in an area monitored by employees, but shall not be in an area where emergency or urgent care is provided. If the collection receptacle is in an opioid treatment facility, it must be located in a room that does not contain other controlled substances and is securely locked with controlled access. |
| (3) | Each
receptacle must also be capable of holding a removable, tamper-evident, and
tear- resistant inner-liner bearing a unique identification number to receive
the drugs.
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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.
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| (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).
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| (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.
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| (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. |
Rule 480-50-.04 Numbered Inner-Liner Requirements
| (1) | A numbered inner-liner shall meet the
following requirements:
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| (2) | Access to the inner-liner shall be restricted to authorized employees for the collector. |
| (3) | The inner-liner shall be sealed by two authorized employees immediately upon removal from the permanent outer container, and the sealed inner-liner shall not be opened, x-rayed, analyzed, or otherwise penetrated. |
| (4) | The authorized collector shall maintain a
sequential log of all numbered inner-liners. The log shall indicate, at a
minimum:
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Rule 480-50-.05 Mail-back Programs
| (1) | Pre-paid mail-back packages may be provided by authorized collectors to patients and their families for a price or at no cost to the patient. |
| (2) | In Georgia, mail-back packages cannot be returned or mailed back to the authorized collector, unless that collector is a licensed reverse distributor. Collectors that are pharmacies cannot receive or dispose of mail back packages. All such mail-back packages must be shipped directly to a licensed reverse distributor for disposal. |
Rule 480-50-.06 Reverse Distributors
| (1) | Any person that reverse distributes a controlled substance shall be registered with the United States Drug Enforcement Administration as a reverse distributor and actively licensed by the Georgia Board of Pharmacy as a reverse distributor. |
| (2) | A reverse distributor shall acquire
controlled substances and non-controlled drugs from a collector in the
following manner:
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| (3) |
Upon acquisition of a drug by delivery or pick-up, a reverse distributor shall:
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| (4) | A reverse distributor shall destroy or cause the destruction of any drug received for the purpose of destruction no later than 30 calendar days after receipt. |
Rule 480-50-.07 Inspections
| (1) | The Georgia Drugs and Narcotics Agency (GDNA) shall have the authority to conduct inspections of any place, premises, or receptacle utilized by any authorized collector in relation to collection, retention, and disposal of drugs. |
| (2) | GDNA shall have the authority to examine, copy, or remove all records required by this rule, and to examine, remove, or inventory all numbered inner-liners. |
| (3) | It shall be the responsibility of any authorized collector to make same available for such inspection, copying, examination, or inventorying by said GDNA. |
| (4) | Following any such examination, inventory, or inspection of records or receptacles, GDNA shall provide to the authorized collector a copy of any written inspection report produced on which any deficiencies or violations are made along with any recommendations, if any, concerning the satisfactory storage, record-keeping, handling, and security of drugs for disposal. |
| (5) | The Pharmacist-in-Charge of each authorized collector shall obtain a copy of the current Board permit of every reverse distributor to which inner-liners are returned. Such copies shall be made available during the GDNA's inspection. |
| (6) | The Pharmacist-in-Charge of each authorized collector shall respond in a written report addressing any discrepancies or deficiencies noted in a GDNA inspection report within two weeks after receipt of the inspection notice. The deficiencies shall be corrected within ten (10) business days. |