Chapter 4729:5-10

4729:5-10-01 Definitions - drug repository programs.

As used in Chapter 4729:5-10 of the Administrative Code:

(A) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(B) "Distributor of dangerous drugs" or "drug distributor" has the same meaning as in rule 4729:6-1-01 of the Administrative Code.

(C) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(D) "Drug repository program" means a program authorized to accept prescription drugs donated or given for the purpose of being dispensed or personally furnished to individuals who are residents of this state and meets eligibility standards established in this chapter.

(E) "Hospital" has the same meaning as in section 3727.01 of the Revised Code.

(F) "Institutional facility" has the same meaning as defined in agency 4729 of the Administrative Code.

(G) "Licensed health care professional" has the same meaning as in section 3715.872 of the Revised Code.

(H) "Nonprofit clinic" has the same meaning as in section 3715.87 of the Revised Code.

(I) "Orally administered cancer drug" means either of the following:

(1) An orally administered dangerous drug that is used to treat cancer or its side effects; or

(2) An orally administered dangerous drug that is used to treat the side effects of a dangerous drug used to treat cancer.

(J) "Original sealed and tamper-evident unit dose packaging" includes single unit dose packaging of oral medications from a manufacturer or a repackager registered with the federal food and drug administration, or from a pharmacy licensed as a terminal distributor of dangerous drugs, and includes injectables, topicals, and aerosols in the manufacturer's or repackager's unopened original tamper-evident packaging.

(K) "Prescription drug" has the same meaning as in section 3715.87 of the Revised Code.

(L) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

Replaces: 4729-35-01


Effective: 10/15/2019
Five Year Review (FYR) Dates: 10/15/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3715.873, and 3719.28
Rule Amplifies: 3715.87 , 3715.871, 3715.872, 3715.873
Prior Effective Dates: 01/01/2004, 01/01/2006

4729:5-10-02 Eligibility requirements for a pharmacy, hospital, or nonprofit.

A pharmacy, hospital, or nonprofit clinic may elect to participate in a drug repository program, pursuant to sections 3715.87 to 3715.873 of the Revised Code, if all of the following requirements are met:

(A) Must be licensed as a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code.

(B) Must comply with all applicable federal and state laws, rules, and regulations.

Replaces: 4729-35-02


Effective: 8/26/2019
Five Year Review (FYR) Dates: 08/26/2024
Promulgated Under: 119.03
Statutory Authority: 3715.873, 4729.26
Rule Amplifies: 3715.87 , 3715.871, 3715.872, 3715.873
Prior Effective Dates: 01/01/2004

4729:5-10-03 Donating drugs.

(A) The following may donate a dangerous drug, pursuant to the eligibility requirements of rule 4729:5-10-04 of the Administrative Code, to a pharmacy, hospital, or nonprofit clinic that elects to participate in a drug repository program:

(1) A licensed terminal distributor of dangerous drugs.

(2) A licensed drug distributor

(3) A person who was legally dispensed or personally furnished a dangerous drug pursuant to a patient-specific drug order.

(B) Except for orally administered cancer drugs described in paragraph (B) of rule 4729:5-10-04 of the Administrative Code, a person electing to donate an eligible dangerous drug shall not have taken custody of the drug prior to the donation. The person may direct the donation through a terminal distributor of dangerous drugs.

(C) A person who resides in an institutional facility and was legally dispensed a dangerous drug pursuant to a patient-specific order may elect to sign and date a donor form prior to donating a drug, which shall state "from this day forward I wish to donate all my remaining unused drugs that are eligible, pursuant to rule 4729:5-10-04 of the Administrative Code, to a drug repository program."

(D) A person designated by durable power of attorney, a guardian, or other individual responsible for the care and well-being of a patient may make the decision to donate an eligible dangerous drug.

Replaces: 4729-35-03


Effective: 10/15/2019
Five Year Review (FYR) Dates: 10/15/2024
Promulgated Under: 119.03
Statutory Authority: 3715.873, 4729.26
Rule Amplifies: 3715.87 , 3715.871, 3715.872, 3715.873
Prior Effective Dates: 01/01/2004

4729:5-10-04 Eligible drugs.

All dangerous drugs may be donated to a pharmacy, hospital, or nonprofit clinic that elects to participate in a drug repository program if the drugs meet all the following requirements:

(A) Except as provided in paragraph (B) of this rule, the drugs are in their original sealed and tamper-evident unit dose packaging. The packaging must be unopened except that the drugs packaged in single unit doses may be accepted and dispensed when the outside packaging is opened if the single unit dose packaging is undisturbed. If the drugs were packaged by a pharmacy, the name of the pharmacy and any other pharmacy identifiers must be removed from the packaging prior to dispensing or personally furnishing to a recipient patient. This may be accomplished by removing the drug from the pharmacy packaging or by removing the name from the outside packaging of a multiple dose, unit dose packaging system.

(1) The drugs have been in the possession of a licensed healthcare professional, terminal distributor of dangerous drugs, or drug distributor and not in the possession of the ultimate user.

(2) The drugs have been stored according to federal and state requirements. The drugs must have an expiration date of six months or greater.

(3) The repository program shall develop and implement standards and procedures to determine, based on a basic visual inspection, that the drugs appear to be unadulterated, safe, and suitable for dispensing.

(4) The packaging must list the lot number and expiration date of the drug.

(5) The drugs must not have any physical signs of tampering or adulteration.

(6) The drug packaging must not have any physical signs of tampering.

(7) All confidential patient information must have been removed from the drug packaging.

(8) Except for controlled substances in a long-acting or extended-release form used for the treatment of opioid dependence or addiction, the drugs must not be controlled substances.

(9) The drugs must not be samples.

(B) Orally administered cancer drugs described in division (C) of section 3715.87 of the Revised Code that are not in original sealed and tamper-evident unit dose packaging may be donated to a drug repository program.

(1) The repository program shall develop and implement standards and procedures to determine, based on a basic visual inspection, that the drugs appear to be unadulterated, safe, and suitable for dispensing.

(2) The drugs have been stored according to federal and state requirements.

(3) The drugs must have an expiration date of six months or greater.

(4) The packaging must list the expiration date of the drug.

(5) The drugs must not have any physical signs of tampering or adulteration.

(6) The drugs must not be controlled substances or drug samples.

(C) In the case of recalls, any donated drugs affected by the recall shall not be dispensed or personally furnished unless the lot number can be determined.

Replaces: 4729-35-04


Effective: 10/15/2019
Five Year Review (FYR) Dates: 10/15/2024
Promulgated Under: 119.03
Statutory Authority: 3715.873, 4729.26
Rule Amplifies: 3715.87 , 3715.871, 3715.872, 3715.873
Prior Effective Dates: 01/01/2004, 01/01/2006

4729:5-10-05 Eligibility requirements to receive drugs.

A pharmacy, hospital, or nonprofit clinic that elects to participate in a drug repository program must determine if a person is eligible to receive drugs. A person must meet the following requirements to become an eligible recipient of drugs from a drug repository program:

(A) Is a resident of Ohio; and

(B) Meets any of the following criteria:

(1) Has no reasonable financial means to pay for the drug prescribed; or

(2) Is a patient of a nonprofit clinic.

Replaces: 4729-35-05


Effective: 8/26/2019
Five Year Review (FYR) Dates: 08/26/2024
Promulgated Under: 119.03
Statutory Authority: 3715.873, 4729.26
Rule Amplifies: 3715.87 , 3715.871, 3715.872, 3715.873
Prior Effective Dates: 01/01/2004, 01/01/2009

4729:5-10-06 Donor and recipient forms.

(A) Each donor must sign a form stating that the donor is the owner of the drug and intends to voluntarily donate the drug to the drug repository program. The donor form must be completed prior to any donation and include at least the following:

(1) The name of the person that was originally dispensed the drugs or the name of the terminal distributor of dangerous drugs or drug distributor that owns the drugs.

(2) The signature of the donor, which may include the person designated by durable power of attorney, a guardian, an individual responsible for the care and well-being of a patient, or the signature of the responsible person or the responsible person's designee of a terminal distributor of dangerous drugs or a drug distributor.

(3) The date the form was signed.

(B) The following donor information must also be documented. This information may be documented on the original signed donor form or on an alternate record. If an alternate record is used, the record must include the name of the donor in addition to the required information in this paragraph.

(1) The brand name or generic name of the drug donated and either the name of the manufacturer or the national drug code number (NDC#).

(2) The strength of the drug donated.

(3) The quantity of the drug donated.

(4) The date the drug was donated.

(C) Prior to receiving donated drugs from a drug repository program, each recipient must sign a form stating they understand the immunity provisions of the program pursuant to division (B) of section 3715.872 of the Revised Code.

Replaces: 4729-35-06, 4729-35-07


Effective: 8/26/2019
Five Year Review (FYR) Dates: 08/26/2024
Promulgated Under: 119.03
Statutory Authority: 3715.873, 4729.26
Rule Amplifies: 3715.87 , 3715.871, 3715.872, 3715.873
Prior Effective Dates: 01/01/2004

4729:5-10-07 Record keeping and handling fee.

(A) Donor forms must be maintained for a minimum of three years in a readily retrievable manner by a terminal distributor of dangerous drugs, a distributor of dangerous drugs, or an institutional facility.

(B) Recipient forms must be maintained for a minimum of three years in a readily retrievable manner by a pharmacy, hospital, or nonprofit clinic.

(C) An invoice must be created by the donor location, which includes a terminal distributor of dangerous drugs, a distributor of dangerous drugs, or an institutional facility where the donor resides. The invoice must include the following information:

(1) The name and address of the donor location.

(2) The brand name or generic name of the drug donated and either the name of the manufacturer or the national drug code number (NDC#).

(3) The strength of the drug.

(4) The quantity of the drug.

(5) The date the drug was sent to the pharmacy, hospital, or nonprofit clinic.

(6) The name and address of the recipient pharmacy, hospital, or nonprofit clinic.

(D) A prescriber must document the distribution of a personally furnished donated repository program drug to the prescriber's patient pursuant to the applicable record keeping rules of division 4729:5 of the Administrative Code and a pharmacy must document the dispensing of a donated repository program drug pursuant to the applicable record keeping rules of division 4729:5 of the Administrative Code. Such records must indicate that the drug distributed to a patient was from a repository program. If recipient forms are used with each dispensing or personal furnishing, this information may be documented on the recipient form.

(E) A copy of the invoice must be maintained for a minimum of three years in a readily retrievable manner by both the donor location, which includes a terminal distributor of dangerous drugs, a distributor of dangerous drugs, or an institutional facility, and the recipient location, which includes a pharmacy, hospital, or nonprofit clinic.

(F) A pharmacy, hospital, or nonprofit clinic may charge the recipient of a donated drug a handling fee up to twenty dollars to cover restocking and dispensing costs. If a drug repository program chooses to charge a handling fee, then the fees collected in any given year shall not exceed the program's total restocking and dispensing costs for that given year.

Replaces: 4729-35-08, 4729-35-09


Effective: 8/26/2019
Five Year Review (FYR) Dates: 08/26/2024
Promulgated Under: 119.03
Statutory Authority: 3715.873
Rule Amplifies: 3715.87 , 3715.871, 3715.872, 3715.873
Prior Effective Dates: 01/01/2004, 02/01/2005, 01/01/2009, 01/01/2011