Unused / Donated Medications Regulations

Pharmacy Practice Act-Regulations

  • Article 18. Utilization of Unused Medications

    68-18-1. Transferring unused medications.
    (a)Each administrator or operator of an adult care home, pharmacist-in-charge of a mail service pharmacy, and administrator of a medical care facility who wants to become a donating entity, as defined in L. 2008, ch. 9, sec. 2 and amendments thereto, shall submit to the board written notification of intent to participate in the unused medications program. The
    notification shall be submitted on a form approved by the board.
    (b) Before the transfer of each unused medication to a qualifying center or clinic, each mail service pharmacy and medical care facility that has become a donating entity as specified in subsection (a) shall perform the following:
    (1) Determine the quality and suitability of each unused medication by a pharmacist’s verification that the unused medication meets the following requirements:
    (A) Can be identified;
    (B) is in the manufacturer’s sealed container, a pharmacy unit-dose package, or a hermetically sealed tamper evident package from the pharmacy;
    (C) has not passed its beyond-use date;
    (D) is not a controlled substance;
    (E) has not been adulterated; and
    (F) is not a medication that can be dispensed only to a patient or resident registered with the drug manufacturer;
    (2) remove the name of the patient or resident and all of the patient’s or resident’s personal identifiers in order to protect confidentiality;
    (3) consult with the qualifying center or clinic to determine whether the qualifying center or clinic is willing to accept each unused medication; and
    (4) ensure that the qualifying center or clinic has a consulting pharmacist and is registered with the board to accept unused medications.
    (c) Before the transfer of each unused medication to a qualifying center or clinic, each adult care home that has become a donating entity as specified in subsection (a) shall meet the requirements specified in paragraphs (b)(2), (3), and (4).
    (d) When a donating entity transfers an unused medication to a qualifying center or clinic, the donating entity shall meet the following requirements:
    (1) Complete a manifest on a form approved by the board; and
    (2) include a copy of the manifest with the unused medications.
    (e) Each donating entity shall maintain a copy of the manifest that the donating entity provided to the qualifying center or clinic for at least five years. The donating entity shall also maintain a copy of the manifest that was signed and returned by the qualifying center or clinic for at least five years.
    (f) A donating entity shall not transfer an unused medication that can be dispensed only to a patient or resident registered with the drug manufacturer.
    (Authorized by and implementing L. 2008, ch. 9, §7; effective Jan. 2, 2009.)

    68-18-2. Accepting unused medications.
    (a) Each qualifying center or clinic that elects to participate in the unused medications program shall submit to the board written notification of intent to participate on a form approved by the board.
    (b) Each qualifying center or clinic shall maintain all unused medications in a storage unit with controlled access.
    (c) After the acceptance of each unused medication from an adult care home that has become a donating entity as specified in K.A.R. 68-18-1(a), each qualifying center or clinic shall perform the following:
    (1) Determine the quality and suitability of each unused medication by verification of a pharmacist that the unused medication meets the following requirements, in addition to the requirements of L. 2008, ch. 9, sec. 4 and amendments thereto:
    (A) Can be identified; and
    (B) is not a medication that can be dispensed only to a patient or resident registered with the drug manufacturer;
    (2) ensure that the name of the patient or resident and all of the patient’s or resident’s personal identifiers have been removed in order to protect confidentiality;
    (3) check each unused medication against the manifest to resolve any discrepancies with the donating entity; and
    (4) complete the manifest and return a copy of the manifest to the donating entity.
    (d) After the acceptance of each unused medication from a mail service pharmacy or a medical care facility that has become a donating entity as specified in K.A.R. 68-18-1(a), each qualifying center or clinic shall perform the following:
    (1) Determine the quality and suitability of each unused medication by the verification of a pharmacist or practitioner that the unused medication meets the following requirements, in addition to the requirements of L. 2008, ch. 9, sec. 4 and amendments thereto:
    (A) Can be identified; and
    (B) is not a medication that can be dispensed only to a patient or resident registered with the drug manufacturer; and
    (2) meet all of the requirements specified in paragraphs (c)(2), (3), and (4). (e) Each qualifying center or clinic shall maintain a copy of the manifest that was provided by the donating entity for at least five years. The qualifying center or clinic shall also maintain a copy of the manifest signed and returned to the donating agency for at least five years.
    (f) A qualifying center or clinic shall not accept or dispense an unused medication that can be dispensed only to a patient or resident registered with the drug manufacturer.
    (Authorized by and implementing L. 2008, ch. 9, §7; effective Jan. 2, 2009.)

    68-18-3. Recall of unused medications.
    (a) If an unused medication is recalled and the qualifying center or clinic does not have the lot number on the label to differentiate between the recalled medications and the nonrecalled medications, all of the unused medications shall be destroyed.
    (b) If a donating entity has transferred an unused medication to a qualifying center or clinic, the medication is subsequently recalled, and the donating entity has been notified of the recall, the donating entity shall be responsible for notifying the qualifying center or clinic of the recall.
    (c) Each qualifying center or clinic in possession of any unused medication that is expired, adulterated, or recalled shall make a manifest for and destroy that medication.
    (d) Following the destruction of any unused medications,
    the manifest shall be signed by the consulting pharmacist and a witness to verify the destruction. Each drug destruction manifest shall be maintained for at least five years.
    (Authorized by and implementing L. 2008, ch. 9, §7; effective Jan. 2, 2009.)