Report Title:

Prescription Drugs; Return for Credit and Reuse; Drug Repository

Description:

Makes clarifying amendments to the return-for-credit-and-reuse procedures for unused prescription drugs dispensed within health care institutions and for donation of previously dispensed prescription drugs. (HD 1)

HOUSE OF REPRESENTATIVES

H.B. NO.

1051

TWENTY-THIRD LEGISLATURE, 2005

H.D. 1

STATE OF HAWAII

  

 

A BILL FOR AN ACT

 

relating to prescription drugs.

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

SECTION 1. Chapter 328B, Hawaii Revised Statutes, is amended as follows:

1. By amending subsections (a) and (b) of section 328B-2 to read:

"(a) Previously dispensed prescription drugs may be returned to the dispensing pharmacy for credit to the payer and subsequent reuse as provided by this chapter; provided that:

(1) The prescription drug:

(A) Is in [its]:

(i) Its original dispensed, unopened, untampered multiple dose container or unopened, untampered single user unit; or

(ii) An in-use multiple dose container subject to appropriate safeguards as defined in rules for public health or operational considerations;

(B) Has remained at all times under the control or direction of a person in the institutional facility or the pharmacy trained and knowledgeable in the storage of drugs, including periods in transit by any carrier for hire or person or entity hired solely to transport prescription drugs;

(C) Is not adulterated or misbranded;

(D) Has been stored under conditions meeting United States Pharmacopoeia standards;

(E) Is returned and redispensed or redistributed before the expiration date or [use by] "use by" date on the multiple dose container or single user unit;

(F) Has not been in the possession of an individual member of the public;

(G) Is not included within the classification of controlled substances, as defined in applicable federal and state laws; and

(H) Is first offered for donation to a drug repository entity pursuant to chapter 328C for local distribution for needy persons;

(2) Appropriate credits and handling fees are applied;

(3) Appropriate recordkeeping provides for documentation of receipt, transfer, and credit;

(4) The prescription drugs are returned only to the original dispensing pharmacy; and

(5) Prescription drugs from individual members of the public are not accepted for reuse.

(b) Prescription drugs are not appropriate for return-for-credit-and-reuse and shall not be returned for credit under this chapter under conditions which include but are not limited to the following:

(1) Product valuation is less than the handling fee;

(2) Market demand makes reuse implausible by the expiration date or [use by] "use by" date;

(3) The product prescription number or patient identifier is not discernable[,]; therefore, credit to the payer is not possible; or

(4) The prescription drugs are in containers that do not have a tamperproof seal demonstrating that [it] the container has never before been opened."

2. By amending subsections (b) and (c) of section 328B-3 to read:

"(b) If prescription drugs returned to the dispensing pharmacy have been previously billed to the payer, the [payer] pharmacy shall [be credited] credit the payer for the quantity of drugs returned, not including the original dispensing fee, and less any handling fee. An appropriate handling fee, not to exceed the institutional facility's actual cost of processing returned prescription drugs and the receiving pharmacy's actual cost of receiving and processing returned prescription drugs, shall be established by the department of human services. The handling fee shall not reduce the credit amount below zero. Dispensed and billed drugs with a valuation below the handling fee shall not be returnable for credit under this chapter.

(c) The pharmacy shall reimburse the institutional facility for the proper storage and recordkeeping of returned drugs from the handling fee [as determined in subsection (b)], if any."

3. By amending subsection (a) of section 328B-4 to read:

"(a) The institutional facility shall keep records of all previously dispensed prescription drugs returned to the dispensing pharmacy. Records shall be retained for five years and shall include at least the following:

(1) The name and address of the institutional facility;

(2) The prescription number or other patient or payer identifier;

(3) The name and strength of the drug;

(4) The name of the manufacturer or the [national drug code;] National Drug Code number;

(5) The quantity of the drug;

(6) The expiration date or [use by] "use by" date;

(7) The date the drug was sent to the pharmacy, repository entity, or any other agent for final disposition;

(8) The name of the pharmacy, repository entity, or any other agent that received or is to receive the drug for final disposition and a description of the disposition, such as returned-for-credit-and-reuse, donated, disposed, or destroyed;

(9) The initials of the person making the entry; and

(10) Certification of the reason for the return of the prescription drug by a prescribing practitioner."

4. By amending subsection (a) of section 328B-5 to read:

"(a) A high managerial agent acting on behalf of the pharmacy shall cause to be filed, with the designated state agency responsible for administering the medicaid program, a certified transaction account detailing every transaction under this chapter. The certified transaction account shall include the following information relative to each drug returned:

(1) If the transaction involved medicaid:

(A) The medicaid provider number of the pharmacy;

(B) The medicaid provider number of the institutional facility;

(C) The name and beneficiary identification number of the medicaid beneficiary to whom the returned drug was originally prescribed;

(D) The name and provider number of the physician who originally prescribed the drug;

(E) The [NDC] National Drug Code number appearing on the original prescription;

(F) The lot number, if available;

(G) The medicaid claim number of the original prescription;

(H) The medicaid transaction number of the credit for the returned drug; and

(I) The reason for the return of the drug;

(2) If the transaction involves the federal medicare program:

(A) A copy of the 204-claim form, or its then existing equivalent, detailing the original transaction;

(B) Documentation of the corresponding credit to the federal medicare program; and

(C) Any other information required by the federal administrators of the medicare program; and

(3) If the transaction involves a private pay patient in an institutional facility, a certification that the payer was properly credited."

SECTION 2. Section 328C-1, Hawaii Revised Statutes, is amended by amending the definition of "prescription drug" to read as follows:

""Prescription drug" means:

(1) Any drug required by federal or state statutes, regulations, or rules to be dispensed only upon prescription, including finished dosage forms and active ingredients subject to section 328-16 or [section] Section 503(b) of the Federal Food, Drug, and Cosmetic Act; or

(2) Any drug product compounded or prepared pursuant to the order of a practitioner, as defined in section 461-1."

SECTION 3. Section 328C-2, Hawaii Revised Statutes, is amended by amending subsection (c) to read as follows:

"(c) [Any donated, previously dispensed, prescription drug:

(1) Shall be in its dispensed, unopened, tamper-evident single user unit;

(2) Shall have remained at all times in the control of a person trained and knowledgeable in the storage and administration of drugs in institutional facilities;

(3) Shall not have been adulterated, misbranded, or stored under conditions contrary to standards established by the United States Pharmacopoeia or the product manufacturer;

(4) Shall be used before the expiration date on the unit;

(5) Shall not have been in the possession of an individual member of the public; and

(6) Shall not be included within the classification of controlled substances, as defined in applicable federal and state laws.]

Previously dispensed prescription drugs may be donated; provided that the prescription drug:

(1) Is in:

(A) Its original dispensed, unopened, untampered multiple dose container or unopened, untampered single user unit; or

(B) An in-use multiple dose container subject to appropriate safeguards as defined in rules for public health or operational considerations;

(2) Has remained at all times under the control or direction of a person in the institutional facility or the pharmacy trained and knowledgeable in the storage of drugs, including periods in transit by any carrier for hire or person or entity hired solely to transport prescription drugs;

(3) Is not adulterated or misbranded;

(4) Has been stored under conditions meeting United States Pharmacopoeia standards;

(5) Is returned and redispensed or redistributed before the expiration date or "use by" date on the multiple dose container or single user unit;

(6) Has not been in the possession of an individual member of the public; and

(7) Is not included within the classification of controlled substances, as defined in applicable federal and state laws."

SECTION 4. Section 328C-7, Hawaii Revised Statutes, is amended by amending subsection (a) to read as follows:

"(a) All previously dispensed prescription drugs donated to repository entities shall be recorded by the institutional facility. Records shall be retained by the institutional facility for five years and shall include the following information:

(1) The name and address of the donating institutional facility;

(2) The name and strength of the drug;

(3) The name of the manufacturer or the [national drug code;] National Drug Code number;

(4) The quantity of the drug;

(5) The expiration or [use by] "use by" date of the drug;

(6) The date the drug was sent to the repository entity or any other agent for final disposition;

(7) The name of the repository entity, or any other agent that received or is to receive the drug for final disposition and a description of the disposition, such as donated, disposed, or destroyed; and

(8) The initials of the person making the entry."

SECTION 5. Section 461-11.5, Hawaii Revised Statutes, is amended to read as follows:

"[[]§461-11.5[]] Return of prescription drugs. Prescription drugs previously dispensed or distributed by a pharmacy for administration to patients in an institutional facility by personnel of the institutional facility may be returned to and redispensed or redistributed by the pharmacist if the prescription drug:

(1) Is in:

(A) Its original dispensed, unopened, untampered multiple dose container or unopened, untampered single user unit; or

(B) An in-use multiple dose container subject to appropriate safeguards as defined in rules for public health or operational considerations;

(2) Has remained at all times under the control or direction of a person in the institutional facility or the pharmacy trained and knowledgeable in the storage of drugs, including periods in transit by any carrier for hire or person or entity hired solely to transport prescription drugs;

(3) Is not adulterated or misbranded;

(4) Has been stored under conditions meeting United States Pharmacopoeia standards;

(5) Is returned and redispensed or redistributed before the expiration date or [use by] "use by" date on the multiple dose container or single user unit;

(6) Has not been in the possession of an individual member of the public; and

(7) Is not included within the classification of controlled substances, as defined in applicable federal and state laws.

Nothing in this [[]section[]] shall be construed to relieve any person from any requirement prescribed by law with respect to drugs included or that may be included within the classification of controlled substances, as defined in applicable federal and state laws. Previously billed returned drugs shall be subject to crediting to the payer pursuant to chapter 328B."

SECTION 6. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.

SECTION 7. This Act shall take effect on July 1, 2020.