What's happening
This bill authorizes and regulates the use of automated patient dispensing and storage systems for distributing drugs and medical devices at certain facilities in New York.
Why it matters
Expands access to medications. by allowing pharmacies to use automated systems (APDSS) to store and dispense prescription and nonprescription drugs, as well as medical devices, at healthcare facilities, potentially speeding up delivery to patients and easing pharmacy workloads—particularly in underserved or high-volume areas.
Creates robust oversight and accountability. by mandating detailed record-keeping, tracking, and security measures (such as camera surveillance, electronic supervision, and biometric/password access), which aim to prevent drug diversion, medication errors, and unauthorized access.
Imposes clear regulatory and operational standards. for pharmacies, including licensure requirements, regular inspections, mandatory training for staff, and annual self-assessments, ensuring that automated dispensing systems meet safety and compliance standards equivalent to traditional pharmacy operations.
Enables remote pharmacist oversight. of these systems, allowing pharmacists to supervise dispensing electronically rather than being physically present at the site, which could improve pharmacy efficiency and facilitate medication distribution in more locations (such as clinics or correctional facilities).
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Who cares
Headline styles
Allow Automated Drug Dispensers
Plain English, a few words. Used as the page title.
Sponsors
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History
- Referred to rules
Full text
4 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
9074
IN SENATE
October 30, 2020
Introduced by Sen. PERSAUD -- read twice and ordered printed, and when printed to be committed to the Committee on Rules
AN ACT to amend the education law and the public health law, in relation to directing the commissioner of health, in consultation with the commissioner of education, the commissioner of mental health, the state board of pharmacy and the commissioner of corrections and community supervision, to promulgate and implement rules and regulations authorizing the use of automated patient dispensing and storage systems for distribution of prescription and non-prescription drugs and medical devices at certain facilities
The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. Subdivision 1 of section 6808 of the education law, as amended by section 2 of part D of chapter 60 of the laws of 2014, is amended to read as follows:
1. No person, firm, corporation or association shall possess drugs, prescriptions or poisons for the purpose of compounding, dispensing, retailing, wholesaling, or manufacturing, or shall offer drugs, prescriptions or poisons for sale at retail or wholesale unless registered by the department as a pharmacy, wholesaler, manufacturer or outsourcing facility; provided, however, that the provisions of this section shall not prohibit the dispensing and/or storage of prescriptions, drugs or medical devices through the use of an automated patient dispensing and storage system as provided in section two hundred eighty-d of the public health law and rules and regulations promulgated pursuant to such section.
§ 2. The public health law is amended by adding a new section 280-d to read as follows:
§ 280-d. Automated patient dispensing and storage systems. 1. The commissioner, in consultation with the commissioner of education, the commissioner of mental health, and the state board of pharmacy, shall promulgate rules and regulations to authorize the licensing and use of automated patient dispensing and storage systems as provided in this section which shall include, but not be limited to, requiring that the
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD17346-03-0
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operator of an automated patient dispensing and storage system holds a registration from the federal drug enforcement agency for the distribution of controlled substances.
2. Definitions. As used in this section:
(a) "Automated drug delivery system" or "ADDS" means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.
(b) "Automated patient dispensing and storage system" or "APDSS" means an ADDS for storage and dispensing of drugs to medical personnel for prompt administration to patients pursuant to prior authorization by a pharmacist.
(c) "Covered entity" means a covered entity as defined in Section 256b of Title 42 of the United States Code.
(d) "Drug" means a prescription drug, a non-prescription drug or overthe-counter medication or supply, and/or a medical device.
(e) "Patient" means an individual for whom medication has been prescribed by any person authorized to prescribe medication pursuant to article one hundred thirty-one, one hundred thirty-one-b or one hundred forty-one of the education law.
(f) "Pharmacy" means a pharmacy which holds a registration from the federal drug enforcement agency for the distribution of controlled substances.
3. Pursuant to the rules and regulations authorized by subdivision one of this section, if all of the following conditions are met, a pharmacy located in the state may provide pharmacy services through the use of an automated patient dispensing system to patients of a covered entity through an APDSS located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy:
(a) The pharmacy obtains a license from the state board of pharmacy to operate the APDSS at the covered entity or an affiliated site. As part of the application, the pharmacy shall provide the address at which the APDSS shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars and may be increased to five hundred dollars. The state board of pharmacy is authorized to lower the renewal fee to not less than two hundred dollars if a lower fee level will provide sufficient resources to support the regulatory activities.
(b) The pharmacy providing the pharmacy services to patients of a covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medicare and Medicaid programs, shall be under contract with that covered entity to provide those pharmacy services through the use of the APDSS.
(c) Drugs stored in an APDSS shall be part of the inventory of the pharmacy providing pharmacy services to patients and drugs dispensed from the APDSS shall be considered to have been dispensed by that pharmacy.
(d) The pharmacy shall maintain records of the acquisition and disposition of drugs stored in the APDSS separate from other pharmacy records.
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(e) The pharmacy shall be solely responsible for the security, operation, and maintenance of the APDSS.
(f) The pharmacy shall provide training regarding the operation and use of the APDSS to both pharmacy and covered entity personnel using the system.
(g) The operation of the APDSS shall be under the supervision of a pharmacist licensed pursuant to article one hundred thirty-seven of the education law acting on behalf of the pharmacy providing services to patients of the covered entity. The pharmacist need not be physically present at the site of the APDSS and may supervise the system electronically.
(h) The state board of pharmacy may issue a license for the operation of an APDSS at an address for which it has issued another site license.
(i) The state board of pharmacy, within thirty days after receipt of an application for an APDSS license, shall conduct a pre-licensure inspection at the proposed location of the APDSS. Relocation of the APDSS shall require a new application for licensure. Replacement of an APDSS shall require notice to such board within thirty days.
(j) The APDSS license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an APDSS license shall be submitted to the state board of pharmacy, if so required by such board.
(k) A pharmacy that holds an APDSS license shall advise the state board of pharmacy in writing within thirty days if use of the APDSS is discontinued.
4. (a) An automated patient dispensing and storage system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.
(b) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law to review such information. These records shall be maintained by the pharmacy for a minimum of three years.
5. Access to the automated patient dispensing and storage system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of one hundred eighty days.
6. The automated patient dispensing and storage system shall make a complete and accurate record of all transactions that will include all users accessing the APDSS and all drugs added to, or removed from, the APDSS.
7. The stocking of an automated patient dispensing and storage system shall be performed by a pharmacist. If the APDSS utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the APDSS and be delivered to the APDSS at the covered entity if all of the following conditions are met:
(a) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist licensed pursuant to article one hundred thirty-seven of the education law.
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(b) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the APDSS in a secure tamper-evidence container.
(c) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing and storage system.
8. Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing and storage system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the APDSS, an inspection of the APDSS machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the APDSS.
9. A pharmacy holding an automated patient dispensing and storage system license shall complete an annual self-assessment, performed pursuant to rules and regulations promulgated pursuant to this section, evaluating the pharmacy's compliance with the education law and all applicable rules and regulations relating to the use of the automated patient dispensing and storage system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the APDSS shall be included in the self-assessment.
10. The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this section and article one hundred thirty-seven of the education law and all applicable rules and regulations and shall maintain those records within the pharmacy holding the APDSS license and separately from other pharmacy records.
11. Rules and regulations providing for the implementation of the provisions of this section within the facilities of all covered entities shall be implemented within three hundred sixty-five days of the effective date of this section.
§ 3. This act shall take effect immediately.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
Title of bill
An act to amend the education law and the public health law, in relation to directing the commissioner of health, in consultation with the commissioner of education, the commissioner of mental health, the state board of pharmacy and the commissioner of corrections and community supervision, to promulgate and implement rules and regulations authoriz- ing the use of automated patient dispensing and storage systems for distribution of prescription and non-prescription drugs and medical devices at certain facilities
Purpose or general idea of bill
The purpose of the bill is to direct the commissioner of health to promulgate and implement rules authorizing the use of automated patient dispensing and storage systems at certain facilities.
Summary of specific provisions
Section 1. Subdivision 1 of section 6808 of the education law, as amended by section 2 of part D of chapter 60 of the laws of 2014, is amended to read as follows: No person, firm, corporation or association shall possess drugs, prescriptions or poisons for the purpose of compounding, dispensing, retailing, wholesaling, or manufacturing, or shall offer drugs, prescriptions or poisons for sale at retail or whole- sale unless registered by the department as a pharmacy, wholesaler, manufacturer or outsourcing facility; provided, however, that the provisions of this section shall not prohibit the dispensing and/or storage of prescriptions, drugs or medical devices through the use of an automated patient dispensing and storage system as provided in section two hundred eighty-d of the public health law and rules and regulations promulgated pursuant to such section.
Read the full memo (660 words)
Justification
This bill aims to make it convenient for patients to get access to their medications at certain facilities. According to Biological Environmental Services and Waste Solutions; "The U.S. Health Care System loses billions of dollars annually manufacturing,distributing,and disposing of unused medications in Long Term Care(LTC) facilities". The automated patient dispensing and storage system lessens the risk of human error. The automated drug dispensing machine prevents the need for facilities to dump unused medications. Doing so will be cost-effective, and it will promote patient safety.
The use of automated patient dispensing and storage systems at certain facilities will make it convenient for college students to be able to get their prescriptions once the college is pharmacy is closed. The automated drug-dispensing machine can be efficient in reducing the risk of medication contamination; the medications are stored in a safe and sterile environment.
Researchers have done studies regarding the importance of automated prescription dispensers on school, campuses,nursing home facilities, long-term care facilities,hospitals, and in-house pharmacies. The auto- mated dispensing machine at certain facilities is beneficial, and it improves customer service. It allows patients to get their medication on time. It prevents further complications that happen when patients do not take their medication for an extended period.
Medication administration in nursing homes and long-term care facilities is prone to many errors that can be detrimental to our senior citizens. The automated drug dispensing machine will make it easier for Registered Nurses and Licensed Practitioners Nurses to get access to their patients' prescribed medication when needed because it is not always convenient having a doctor on site all the time. The state of Illinois allows for the use of automated drug prescription machines in any licensed hospital, long-term care facility, or hospice facility.
The automated patient dispensing machine or storage ensures accuracy by maintaining records of all the medications that were either packaged or dispersed. Such data will be easily accessible to the pharmacists and can be shared with other healthcare professionals when needed. This bill aims to facilitate patient safety, cost reduction while incorporating rapid innovation of technology into a safe medication process.
Prior legislative history
None
Fiscal implications
None
Effective date
This act shall take effect immediately. Rules and regulations providing for the implementation of the provisions of this section within the facilities of all covered entities shall be implemented within three hundred sixty-five days of the effective date of this section.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.