What's happening
This bill authorizes and regulates the use of automated patient dispensing and storage systems for distributing drugs and medical devices directly to patients at certain New York pharmacy locations.
Why it matters
Expands patient access and convenience. By allowing pharmacies to use automated dispensing systems (like medication vending machines), patients may pick up prescriptions and medical devices outside of regular pharmacy hours or without waiting in line, potentially improving medication adherence and reducing barriers to access.
Balances automation with pharmacist oversight. The law requires that pharmacists authorize dispensing and review prescriptions for contraindications, ensuring that the shift toward automation doesn't remove the pharmacist's clinical oversight or patient counseling, especially for first-time medications.
Sets strict operational and security requirements. Pharmacies must meet licensing standards, track transactions, maintain detailed records, restrict and monitor access (including using cameras or biometric systems), and conduct regular reviews and self-assessments. These measures are designed to prevent diversion, ensure patient safety, and maintain accountability.
Limits on scale and ongoing regulatory review. Each pharmacy is capped at a certain number of automated units and must provide written policies, staff training, and annual system assessments. This helps prevent over-proliferation of the systems without adequate oversight and ensures that patient safety and quality assurance remain priorities as technology is introduced.
Albany, before your first meeting.
Every bill that moved yesterday, summarized in a sentence and ranked by impact. The Albany Scorecard follows on Sundays.
Free. Unsubscribe in one click. Want alerts on specific bills? Create an account.
Who cares
Headline styles
Allow Pharmacy Drug Machines
Plain English, a few words. Used as the page title.
Sponsors
No co-sponsors yet.
History
- Referred to rules
Full text
5 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
9068
IN SENATE
October 28, 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, and the state board of pharmacy, 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 directly to patients at certain pharmacy locations
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 at pharmacies. 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,
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD17345-03-0
S. 9068 2
requiring that the 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 directly to patients pursuant to prior authorization by a pharmacist.
(c) "Drug" means a prescription drug, a non-prescription drug or overthe-counter medication or supply, and/or a medical device.
(d) "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.
(e) "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 individual patients as described in subdivision five of this section:
(a) The pharmacy obtains a license from the state board of pharmacy to operate the APDSS at or adjacent to the pharmacy, as applicable. As part of the application, the pharmacy shall provide the address at which the APDSS shall be placed. 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) 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.
(c) The pharmacy shall maintain records of the acquisition and disposition of drugs stored in the APDSS separate from other pharmacy records.
(d) The pharmacy shall be solely responsible for the security, operation, and maintenance of the APDSS.
(e) The pharmacy shall provide training regarding the operation and use of the APDSS to pharmacy personnel using the system.
(f) 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. The pharmacist need not be physically present at the site of the APDSS and may supervise the system electronically.
(g) 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,
S. 9068 3
including but not limited to drive-through pharmacy areas and other areas adjacent to the physical location occupied by a pharmacy.
(h) 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.
(i) 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.
(j) 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. Drugs from an automated patient dispensing and storage system may be dispensed directly to a patient from a drive-through pharmacy aisle or other location adjacent to the physical location occupied by the pharmacy, if all of the following requirements are met:
(a) The pharmacy develops, implements, and annually reviews written policies and procedures with respect to all of the following:
(i) the pharmacy maintains the security of the APDSS and the drugs within that APDSS;
(ii) the pharmacy determines and applies inclusion criteria regarding which drugs are appropriate for placement in the APDSS and for which patients;
(iii) the pharmacy ensures that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the APDSS;
(iv) the pharmacy describes the assignment of responsibilities to, and training of pharmacy personnel regarding maintenance and filling procedures for the APDSS;
(v) the pharmacy orients participating patients on the use of the APDSS, notifying patients when expected prescription medications are not available in the APDSS, and ensuring that patient use of the APDSS does not interfere with delivery of drugs; and
(vi) the pharmacy ensures delivery of drugs to patients expecting to receive them from the APDSS in the event the automated patient dispensing and storage system is disabled or malfunctions.
(b) The automated patient dispensing and storage system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs from an APDSS and whose use of the APDSS meet the criteria pursuant to paragraph (a) of this subdivision.
(c) The automated patient dispensing and storage system shall have a means to identify each patient and only release the identified patient's drugs to the patient or the patient's agent.
S. 9068 4
(d) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.
(e) Drugs shall be dispensed from the automated patient dispensing and storage system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patient's profile for potential contraindications and adverse drug reactions.
(f) All drugs dispensed from the automated patient dispensing and storage system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed pursuant to article one hundred thirty-seven of the education law in one of the following manners: (i) in person; (ii) through a drive-through prescription dispensing window; (iii) via a telecommunications link that has two-way audio and video; or (iv) through a telephone call between the pharmacist and the patient or the patient's appointed representative with the prescribing physician present for the duration of the call.
(g) The automated patient dispensing and storage system shall include a notice, prominently posted on the automated patient dispensing and storage system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing and storage system license for that APDSS.
(h) The labels on all drugs dispensed by the automated patient dispensing and storage system shall comply with all New York state and federal requirements for labelling of drugs prescribed and dispensed in this state.
(i) Any complaint, error, or omission involving the automated patient dispensing and storage system shall be reviewed as part of the pharmacy's quality assurance program.
(j) The state board of pharmacy shall not issue a pharmacy more than fifteen licenses for automated patient dispensing and storage system units under this section. The state board of pharmacy may adopt regulations to reduce the number of APDSS licenses that may be issued to a pharmacy.
(k) The pharmacy holding the license for the automated patient dispensing and storage system shall maintain the policies and procedures developed pursuant to paragraph (a) of this subdivision for three years after the last date of use of that APDSS.
6. 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.
7. 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.
8. 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 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
S. 9068 5
technician working under the direct supervision of a pharmacist licensed pursuant to article one hundred thirty-seven of the education law.
(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.
9. 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.
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, and the state board of pharmacy, to promulgate and implement rules and regu- lations authorizing the use of automated patient dispensing and storage systems for distribution of prescription and non-prescription drugs and medical devices directly to patients at certain pharmacy locations
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 pharmacies.
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 promulgate pursuant to such section.
Read the full memo (810 words)
Justification
This legislation allows for patient safety, pharmacist commitment to direct patient care, cost reduction. Imagine leaving the hospital with a child whose life depends on his or her prescription drugs in the middle of the night, there is not a pharmacy in your rural area, and the clos- est one to your town closed at nine pm. Your child would have to wait until the next business day for a pharmacist to process the medication, which can take a few hours. Anything can happen while waiting until the next day to get that prescription refill.
An automated dispensing machine is a dispersed medication supply system that is used as computer-controlled storage to dispense, and tracking of medications. Automated prescription drug dispensers are useful mech- anisms that can improve patient safety, reduce pharmacist-processing time during inventories.
This system is widely used in many hospitals and is crucial in improving patient safety. This system will lessen the likelihood of either pharma- cy staff being confused or miscounting pills that look alike. Further- more, the automated prescription dispensers will allow those residing outside of the city to have access to their medications once being discharged from the hospital.
The automated prescription dispensers will make it a much easier process for parents and others to get their prescribed medications, which can improve their health. The automated dispensing machine does not only benefit residents in rural areas; it makes it easier for college students that depend on therapeutical medicine to get their medications immediately.
The automated dispenser makes it convenient to send prescriptions directly from a doctor's office to a pharmacist who can scan the patient's file, refill the order, and put it into the dispenser for pick up. Based on Rural Health Information Hub, pharmacies in rural areas have much higher chances not to stay open due to "low volume-purchasing, slim profit margins, unfavorable insurance practices, limited pharmacy workforce, and the slow growth of many rural economies".
Those in rural communities have difficulties accessing the pharmaceu- tical service due to a lack of transportation to travel to the pharmacy in the next town. According to the Bureau of Labor Statistics, Occupa- tional Employment Statistics for 2017:" less than 12% of all pharmacists in the U.S. are employed in nonmetropolitan areas". The automated prescription dispensers will remedy the lack of comprehensive pharmacy service. It will bring a significant amount of pharmacy service, care, and medication availability to these communities.
According to the RUPRI Center for Rural Health Policy's Update Independ- ently Owned Pharmacy Closures in Rural America:"2003-2018, 1,231 inde- pendently owned rural pharmacies were lost from March 2003 to March 2018, including 630 that served as their rural community's only retail pharmacy". These machines would diminish potential thefts and human error; the automated dispensing machines software would monitor dispensed pills.
This bill allows pharmacists the ability to track and monitor the drug usage pattern. Such data will be easily accessible and can be shared with other healthcare professionals when needed. This bill prevents pharmacies in rural areas from closing their doors due to financial reasons.
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 shall be imple- mented 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.