House File 325 - Introduced
HOUSE FILE
BY CARROLL
Passed House, Date Passed Senate, Date
Vote: Ayes Nays Vote: Ayes Nays
Approved
A BILL FOR
1 An Act creating a prescription drug donation and redispensing
2 pilot program, and providing penalties.
3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
4 TLSB 2240YH 81
5 pf/sh/8
PAG LIN
1 1 Section 1. NEW SECTION. 135M.1 PURPOSE.
1 2 The purpose of this chapter is to improve the health of
1 3 low=income Iowans through a prescription drug donation and
1 4 redispensing program that authorizes charitable clinic
1 5 pharmacies to redispense prescription drugs that would
1 6 otherwise be destroyed.
1 7 Sec. 2. NEW SECTION. 135M.2 DEFINITIONS.
1 8 As used in this chapter, unless the context otherwise
1 9 requires:
1 10 1. "Charitable clinic" means a charitable nonprofit
1 11 corporation or facility organized under chapter 504 or 504A
1 12 that meets all of the following criteria:
1 13 a. Is described in the federal Internal Revenue Code, 26
1 14 U.S.C. } 501(c)(3), and is exempt from income taxation under
1 15 26 U.S.C. } 501(a).
1 16 b. Provides advice, counseling, diagnosis, treatment,
1 17 surgery, care, or services relating to the preservation or
1 18 maintenance of health on an outpatient basis for a period of
1 19 less than twenty=four consecutive hours per day to persons not
1 20 residing in or confined to the facility.
1 21 c. Charges an administrative fee or requests a donation
1 22 not to exceed ten dollars per visit.
1 23 d. Has a licensed outpatient pharmacy.
1 24 2. "Charitable clinic pharmacy" means a pharmacy at a site
1 25 where prescriptions are dispensed by a charitable clinic free
1 26 of charge to appropriately screened and qualified indigent
1 27 patients.
1 28 3. "Controlled substance" means the same as defined in
1 29 section 155A.3.
1 30 4. "Department" means the Iowa department of public
1 31 health.
1 32 5. "Indigent" means a person with an income that is below
1 33 two hundred percent of the federal poverty level as defined by
1 34 the most recently revised poverty income guidelines published
1 35 by the United States department of health and human services.
2 1 6. "Nursing facility" means the same as defined in section
2 2 135C.1.
2 3 7. "Prescription drug" means the same as defined in
2 4 section 155A.3, but does not include controlled substances.
2 5 8. "Proper transfer" means the storage, handling, and
2 6 distribution of a prescription drug in accordance with its
2 7 label and in its dispensed, sealed, tamper=evident, single=
2 8 user unit.
2 9 Sec. 3. NEW SECTION. 135M.3 PRESCRIPTION DRUG DONATION
2 10 AND REDISPENSING PILOT PROGRAM.
2 11 1. The Iowa department of public health, in cooperation
2 12 with the board of pharmacy examiners, shall establish a pilot
2 13 program, consistent with public health and safety, to provide
2 14 for the proper transfer of unused prescription drugs from
2 15 nursing facilities to charitable clinic pharmacies for the
2 16 purpose of redistributing the prescription drugs to indigent
2 17 individuals.
2 18 2. Participation in the program by nursing facilities,
2 19 charitable clinics, charitable clinic pharmacies, drug
2 20 manufacturers, and individuals shall be voluntary.
2 21 Sec. 4. NEW SECTION. 135M.4 PROGRAM REQUIREMENTS ==
2 22 RULES.
2 23 The department shall adopt rules, in cooperation with the
2 24 board of pharmacy examiners, to provide for all of the
2 25 following:
2 26 1. Specific requirements for a charitable clinic pharmacy
2 27 to qualify for participation in and to participate in the
2 28 pilot program.
2 29 2. Contract forms to be used by charitable clinics and
2 30 nursing facilities in entering into contractual agreements
2 31 under the program.
2 32 3. Forms and procedures for authorization of individuals
2 33 to physically transfer the prescription drugs from a nursing
2 34 facility to a charitable clinic.
2 35 4. Forms and procedures to authorize a donor to donate
3 1 unused prescription drugs and to consent to voluntarily
3 2 donating the prescription drugs.
3 3 5. Waiver of liability forms to be signed by indigent
3 4 individuals receiving prescription drugs under the program.
3 5 Sec. 5. NEW SECTION. 135M.5 DONATIONS OF UNUSED
3 6 PRESCRIPTION DRUGS == REDISPENSING.
3 7 1. A charitable clinic may accept prescription drugs
3 8 obtained from a nursing facility for relabeling and
3 9 redispensing by the charitable clinic pharmacy free of charge
3 10 and pursuant to a valid prescription order to an indigent
3 11 patient.
3 12 2. The donor resident of the nursing facility shall be
3 13 considered the owner of the prescription drug and entitled to
3 14 donate the prescription drug for use by a charitable clinic.
3 15 3. a. A nursing facility may enter into a contract with
3 16 any charitable clinic for the transfer of prescription drugs
3 17 under this section. Prescription drugs shall not be
3 18 transferred under this section without such contract.
3 19 b. A contract entered into under this subsection shall be
3 20 approved by the board of pharmacy examiners, in cooperation
3 21 with the department.
3 22 c. A contract entered into under this subsection shall
3 23 specify procedures for ensuring a safe chain of custody to
3 24 protect the safety of all transferred prescription drugs.
3 25 d. The contract may specify that the charitable clinic
3 26 will do one of the following:
3 27 (1) Define a specified set of prescription drugs that will
3 28 be transferred from the nursing facility to the charitable
3 29 clinic.
3 30 (2) Periodically request the transfer of particular
3 31 prescription drugs.
3 32 (3) Receive all prescription drugs that the nursing
3 33 facility is authorized to transfer under this chapter.
3 34 (4) Make such other provisions for transfer of
3 35 prescription drugs as may be approved by the board of pharmacy
4 1 examiners.
4 2 e. The pharmacist in charge of a charitable clinic shall
4 3 determine the description of the prescription drugs to be
4 4 included in the contract.
4 5 4. Donations of prescription drugs to a charitable clinic
4 6 shall meet all of the following requirements:
4 7 a. Only prescription drugs in their original sealed and
4 8 tamper=evident packaging shall be accepted. However,
4 9 prescription drugs in single=unit doses or blister packs with
4 10 the outside packaging opened may be accepted if the single=
4 11 unit dose packaging remains intact.
4 12 b. The pharmacist of the charitable clinic pharmacy
4 13 determines that the prescription drug is not adulterated or
4 14 misbranded and is safe to redispense.
4 15 c. If the integrity of a prescription drug cannot be
4 16 assured, the prescription drug is not accepted for
4 17 redispensing by the pharmacist of the charitable clinic
4 18 pharmacy.
4 19 d. The prescription drugs are physically transferred from
4 20 the nursing facility to a charitable clinic pharmacy by a
4 21 person authorized by the board of pharmacy examiners to
4 22 transfer the prescription drugs for the charitable clinic.
4 23 e. The donor executes a form stating that the donor is the
4 24 owner of the prescription drugs and intends to voluntarily
4 25 donate them to a charitable clinic pharmacy and the nursing
4 26 facility in which the donor resides retains the donor form.
4 27 f. The donor's name, prescription number, and any other
4 28 identifying marks are obliterated from the packaging before
4 29 the nursing facility transfers the prescription drug to the
4 30 charitable clinic.
4 31 g. The name, strength, and expiration date of the
4 32 prescription drug remain on the package label.
4 33 h. The redispensed drug is assigned the same expiration
4 34 date as appears on the original package.
4 35 i. Expired prescription drugs accepted by a charitable
5 1 clinic pharmacy are not redispensed and are destroyed
5 2 according to the charitable clinic pharmacy's destruction
5 3 procedures.
5 4 j. The charitable clinic pharmacy does not accept
5 5 controlled substances.
5 6 5. a. If a nursing facility that transfers prescription
5 7 drugs to a charitable clinic receives a notice from a pharmacy
5 8 that a prescription drug has been recalled, the nursing
5 9 facility shall inform the clinic of the recall.
5 10 b. If a charitable clinic receives a recall notification
5 11 from a nursing facility, the clinic shall perform a uniform
5 12 destruction of all of the recalled prescription drugs in the
5 13 nursing facility.
5 14 6. A prescription drug dispensed through a charitable
5 15 clinic pharmacy shall not be eligible for reimbursement under
5 16 the medical assistance program.
5 17 7. Indigent individuals receiving prescription drugs under
5 18 the program shall sign a waiver form releasing the nursing
5 19 facility, the charitable clinic, the charitable clinic
5 20 pharmacy, the donor, and the donor's estate from liability.
5 21 Sec. 6. NEW SECTION. 135M.6 EXEMPTION FROM DISCIPLINARY
5 22 ACTION, CIVIL LIABILITY, AND CRIMINAL PROSECUTION.
5 23 1. All of the following persons shall be exempt from
5 24 professional disciplinary action, civil liability, or criminal
5 25 prosecution for actions taken under the program in the absence
5 26 of bad faith and if the person acts in conformity with any
5 27 applicable professional standards and requirements:
5 28 a. The donor and the donor's estate.
5 29 b. The nursing facility that transfers the prescription
5 30 drugs.
5 31 c. The prescribing physician or other person to whom
5 32 prescribing is delegated by the physician.
5 33 d. The charitable clinic.
5 34 e. The charitable clinic pharmacy.
5 35 f. The pharmacy that originally dispensed the prescription
6 1 drugs.
6 2 g. The pharmacist who originally dispensed the
6 3 prescription drugs and the pharmacist who redispensed the
6 4 donated prescription drugs.
6 5 h. The Iowa department of public health.
6 6 i. The department of human services.
6 7 j. The board of pharmacy examiners.
6 8 2. In the absence of bad faith, a drug manufacturer shall
6 9 not be subject to criminal prosecution or civil liability for
6 10 injury, death, or loss to persons or property for matters
6 11 related to the donation, acceptance, or redispensing of a drug
6 12 manufactured by the drug manufacturer that is donated by any
6 13 person under the program, including but not limited to
6 14 liability for failure to provide the product or consumer
6 15 package insert information or the expiration date of the
6 16 donated prescription drugs. This subsection does not exempt a
6 17 drug manufacturer from criminal prosecution or civil liability
6 18 for a previously undisclosed product defect.
6 19 3. This chapter shall not be construed to apply to issues
6 20 of liability outside the scope of the program.
6 21 Sec. 7. NEW SECTION. 135M.7 SAMPLE PRESCRIPTION DRUGS.
6 22 This chapter shall not be construed to restrict the use of
6 23 samples by a physician or other health care professional
6 24 during the course of work at a charitable clinic whether or
6 25 not the charitable clinic has a licensed outpatient pharmacy.
6 26 Sec. 8. NEW SECTION. 135M.8 RESALE PROHIBITED.
6 27 This chapter shall not be construed to authorize the resale
6 28 of prescription drugs by any person.
6 29 Sec. 9. NEW SECTION. 135M.9 CRIMINAL PENALTY ==
6 30 PROFESSIONAL DISCIPLINARY ACTION.
6 31 Any person who knowingly violates any provision of this
6 32 chapter, or of the rules of the department adopted under this
6 33 chapter, is guilty of a serious misdemeanor and is subject to
6 34 professional disciplinary action, if applicable.
6 35 Sec. 10. NEW SECTION. 135M.10 ANNUAL PROGRAM REPORT.
7 1 The department shall submit a report to the governor and
7 2 the general assembly by September 1, 2006, and annually
7 3 thereafter, regarding the progress of the program and any
7 4 recommendations regarding the program.
7 5 EXPLANATION
7 6 This bill directs the Iowa department of public health, in
7 7 cooperation with the board of pharmacy examiners, to establish
7 8 a pilot program to provide for the proper transfer of unused
7 9 prescription drugs from nursing facilities to charitable
7 10 clinic pharmacies for the purpose of redistributing the
7 11 prescription drugs to indigent individuals. Participation in
7 12 the program by nursing facilities, charitable clinics,
7 13 charitable clinic pharmacies, drug manufacturers, and
7 14 individuals is voluntary.
7 15 The bill provides definitions and procedures and
7 16 requirements for the donation of unused prescription drugs and
7 17 the redispensing of such drugs; provides for the adoption of
7 18 rules for the pilot program; provides for exemption from
7 19 disciplinary action, civil liability, and criminal prosecution
7 20 for those involved in the program in the absence of bad faith
7 21 and adherence to applicable professional standards and
7 22 requirements; provides that the program does not restrict the
7 23 use of sample prescription drugs; provides that the bill does
7 24 not authorize the resale of prescription drugs; and requires
7 25 the submission of annual reports regarding the program by the
7 26 Iowa department of public health to the governor and the
7 27 general assembly.
7 28 The bill also provides that a person who knowingly violates
7 29 any provision of the chapter or any rule adopted under the
7 30 chapter is guilty of a serious misdemeanor and is subject to
7 31 professional disciplinary action, if applicable.
7 32 LSB 2240YH 81
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