Chapter 4729-35 Drug Repository Programs

4729-35-01 Definitions.

As used in Chapter 4729-35 of the Administrative Code:

(A) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code and in rule 4729-9-01 of the Administrative Code.

(B) "Drug repository program" has the same meaning as in sections 3715.87 to 3715.873 of the Revised Code.

(C) "Hospital" has the same meaning as in section 3715.87 of the Revised Code.

(D) "Institutional facility" has the same meaning as in rule 4729-17-01 of the Administrative Code.

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

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

(G) "Original sealed and tamper-evident unit dose packaging" includes single unit dose packaging of oral medications from a manufacturer or a repackager licensed 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.

R.C. 119.032 review dates: 04/03/2014 and 04/03/2019
Promulgated Under: 119.03
Statutory Authority: 3715.873 , 4729.26
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004, 1/1/2006

4729-35-02 Eligibility requirements for a pharmacy, hospital, or nonprofit.

A pharmacy, hospital, or nonprofit clinic may elect to participate in the 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 federal and state laws, rules, and regulations.

R.C. 119.032 review dates: 04/03/2014 and 04/03/2019
Promulgated Under: 119.03
Statutory Authority: 3715.873 , 4729.26
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004

4729-35-03 Donating drugs.

(A) The following may donate a dangerous drug, pursuant to the eligibility requirements of rule 4729-35-04 of the Administrative Code, to a pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository program:

(1) A licensed terminal distributor of dangerous drugs.

(2) A licensed wholesale distributor of dangerous drugs.

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

(B) 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 4729-35-04 of the Administrative Code, to the 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.

R.C. 119.032 review dates: 04/03/2014 and 04/03/2019
Promulgated Under: 119.03
Statutory Authority: 3715.873 , 4729.26
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004

4729-35-04 Eligible drugs.

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

(A) 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 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.

(B) The drugs have been in the possession of a licensed healthcare professional and not in the possession of the ultimate user.

(C) The drugs have been stored according to Federal Food and Drug Administration storage requirements.

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

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

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

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

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

R.C. 119.032 review dates: 04/03/2014 and 04/03/2019
Promulgated Under: 119.03
Statutory Authority: 3715.873 , 4729.26
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004, 1/1/2006

4729-35-05 Eligibility requirements to receive drugs.

A pharmacy, hospital, or nonprofit clinic that elects to participate in the 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 the drug repository program:

(A) Is a resident of Ohio, and

(B)

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

(2) Is a patient of a nonprofit clinic.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/26/2008 and 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3715.873
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004

4729-35-06 Donor form.

(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 wholesale distributor of dangerous drugs 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 his/her designee from a terminal distributor of dangerous drugs or a wholesale distributor of dangerous drugs.

(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 of the drug donated, or the generic name and list 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.

R.C. 119.032 review dates: 04/03/2014 and 04/03/2019
Promulgated Under: 119.03
Statutory Authority: 3715.873 , 4729.26
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004

4729-35-07 Recipient form.

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: 4729-35-07

Effective: 01/01/2009
R.C. 119.032 review dates: 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3715.873
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004

4729-35-08 Record keeping.

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

(B) Recipient forms must be maintained for a minimum of three years 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 wholesale distributor of dangerous drugs, or an institutional facility where the donor resides. The invoice must include at least the following information:

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

(2) The brand name of the drug donated, or the generic name and list 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 a 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 donated repository program drug to his/her patient pursuant to rule 4729-9-22 of the Administrative Code and a pharmacy must document the dispensing of a donated repository program drug pursuant to rule 4729-5-27 of the Administrative Code. Both records must indicate that the drug distributed to a patient was from the repository program. If recipient forms are used with each dispensing, this information may be documented on the recipient form.

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

Effective: 01/01/2009
R.C. 119.032 review dates: 09/26/2008 and 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3715.873
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004, 2/1/2005

4729-35-09 Handling fee.

A pharmacy, a hospital, or a 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: 4729-35-09

Effective: 01/01/2011
R.C. 119.032 review dates: 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3715.873
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/04