What's happening
This bill allows unregistered out-of-state pharmacies to deliver prescription drugs to New York in emergencies or specific patient cases, under strict conditions.
Why it matters
Improves emergency access to critical medications. by allowing New York pharmacies to temporarily receive prescription drugs from out-of-state pharmacies that aren’t formally registered in New York, but only in cases of specific patient need or during declared public health emergencies.
Establishes robust safeguards and documentation requirements. Receiving pharmacies must maintain detailed records for six years, verify the out-of-state pharmacy’s home-state license, and ensure each transaction is for a clearly identified patient or an official emergency.
Limits scope to ensure safety and prevent abuse. Only FDA-approved, non-compounded drugs can be transferred; no controlled substances are permitted; packaging must be original and traceable; and prices are capped at the item’s Wholesale Acquisition Cost to prevent price gouging.
Imposes accountability on out-of-state suppliers. Unregistered out-of-state pharmacies become subject to New York jurisdiction for any infractions and must cooperate with state investigations, enhancing consumer protection even when drugs cross state lines.
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Who cares
Headline styles
Allow Emergency Out-of-State Drugs
Plain English, a few words. Used as the page title.
Sponsors
3 Co-sponsors
History
- Referred to higher education
- Referred to higher education
Companion bill
The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.
Let Out-of-State Pharmacies Help
In Assembly Committee · Higher Education · Sponsor Jeffrey Dinowitz
Full text
4 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
406
2025-2026 Regular Sessions
IN SENATE (Prefiled)
January 8, 2025
Introduced by Sens. BROUK, LIU, SEPULVEDA, WEBB -- read twice and ordered printed, and when printed to be committed to the Committee on Higher Education
AN ACT to amend the education law, in relation to the registration of nonresident pharmacies, manufacturers, wholesalers and outsourcing facilities that deliver prescription drugs to other establishments, authorized prescribers and patients residing in this state
The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. Subdivision 2 of section 6808-b of the education law, as amended by chapter 567 of the laws of 2002, is amended to read as follows:
2. Registration. (a) All nonresident establishments that ship, mail, or deliver prescription drugs and/or devices to other registered establishments, authorized prescribers, and/or patients into this state shall be registered with the department; except that such registration shall not apply to intra-company transfers between any division, affiliate, subsidiaries, parent or other entities under complete common ownership and control. The provisions of this subdivision shall apply solely to nonresident establishments and shall not affect any other provision of this article.
(b) Notwithstanding the provisions of this article, an unregistered nonresident establishment may ship, mail, or deliver prescription drugs and/or devices to registered establishments in this state in cases of a specific patient need or a declared public health emergency, provided that:
(i) the unlicensed establishment is appropriately licensed in its home state, and documentation of the license verification can be maintained by the resident establishment in a manner determined by the department;
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD01654-01-5
(ii) in cases of specific patient need, the registered establishment shall maintain documentation that the transfer is for such purpose in a manner determined by the department;
(iii) the resident pharmacy complies with all recordkeeping requirements of the department for each drug or device received from any unregistered nonresident establishment;
(iv) all documentation and records are retained and are readily retrievable by the resident establishment for a period of six years;
(v) the prescription drug or device was manufactured by an authorized FDA registered drug manufacturer and is not a compounded drug. The unregistered nonresident establishment shall only deliver or trade a drug or device salable on prescription only that it receives from a manufacturer, a wholesale distributor or a pharmacy in accordance with the federal Drug Supply Chain Security Act (DSCSA);
(vi) the nonresident establishment from which the drug is being obtained receives a request for the drug that identifies the drug's brand name or generic name, quality, quantity, and size. Such drug shall not be expired at the time of the exchange;
(vii) the drug being obtained includes with the drug a packaging checklist confirming that the drug being delivered or traded matches the information identified on the request, and the drug is delivered or traded in the original manufacturer's packaging, whether sealed or unsealed, with package insert, the drug's national drug code, lot number, and expiration date conspicuously identified on the packaging. If the original manufacturer's packaging is unsealed at the time of the delivery or trade, the delivery or trade may include a quantity of the drug that is less than the quantity contained in the original manufacturer's packaging. However, a pharmacy shall not trade or deliver more than one unsealed or partial quantity of the drug during any consecutive ninety-day period;
(viii) notwithstanding the language of this section, nothing shall be interpreted to allow for the sale, trade or exchange of a controlled substance as defined by article thirty-three of the public health law; and
(ix) the sale/transfer price of any item exchanged under this section may not exceed one hundred percent of the item's Wholesale Acquisition Cost (WAC) at the time of the sale.
(c) A pharmacy that receives notification from an unregistered nonresident establishment that a delivery or trade involved a drug or device salable on prescription only that is an illegitimate, recalled, or counterfeit product shall immediately notify the state board of pharmacy, and the FDA.
(d) Any unregistered nonresident establishment involved in a sale, exchange, or transaction under this section is subject to the jurisdiction of the state of New York regarding said sale, exchange or transaction. Such establishment shall cooperate with agents of the state of New York if said agent is conducting an audit or investigation into the sale, exchange or transaction, and violations of this section shall be punishable according to regulations promulgated by the department and the laws of this state.
(e) For purposes of this subdivision "specific patient need" is defined as the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need in accordance with the federal Drug Supply Chain Security Act.
§ 2. Subdivision 2 of section 6808-b of the education law, as amended by chapter 491 of the laws of 2024, is amended to read as follows:
2. Registration. (a) All nonresident establishments that ship, mail, or deliver prescription drugs and/or devices to other registered establishments, authorized prescribers, and/or patients into this state shall be registered with the department; except that such registration shall not apply to intra-company transfers between any division, affiliate, subsidiaries, parent or other entities under complete common ownership and control. The provisions of this subdivision shall apply solely to nonresident establishments and shall not affect any other provision of this article.
(b) Notwithstanding the provisions of this article, an unregistered nonresident establishment may ship, mail, or deliver prescription drugs and/or devices to registered establishments in this state in cases of a specific patient need or a declared public health emergency, provided that:
(i) the unlicensed establishment is appropriately licensed in its home state, and documentation of the license verification can be maintained by the resident establishment in a manner determined by the department;
(ii) in cases of specific patient need, the registered establishment shall maintain documentation that the transfer is for such purpose in a manner determined by the department;
(iii) the resident pharmacy complies with all recordkeeping requirements of the department for each drug or device received from any unregistered nonresident establishment;
(iv) all documentation and records are retained and are readily retrievable by the resident establishment for a period of six years;
(v) the prescription drug or device was manufactured by an authorized FDA registered drug manufacturer and is not a compounded drug. The unregistered nonresident establishment shall only deliver or trade a drug or device salable on prescription only that it receives from a manufacturer, a wholesale distributor or a pharmacy in accordance with the federal Drug Supply Chain Security Act (DSCSA);
(vi) the nonresident establishment from which the drug is being obtained receives a request for the drug that identifies the drug's brand name or generic name, quality, quantity, and size. Such drug shall not be expired at the time of the exchange;
(vii) the drug being obtained includes with the drug a packaging checklist confirming that the drug being delivered or traded matches the information identified on the request, and the drug is delivered or traded in the original manufacturer's packaging, whether sealed or unsealed, with package insert, the drug's national drug code, lot number, and expiration date conspicuously identified on the packaging. If the original manufacturer's packaging is unsealed at the time of the delivery or trade, the delivery or trade may include a quantity of the drug that is less than the quantity contained in the original manufacturer's packaging. However, a pharmacy shall not trade or deliver more than one unsealed or partial quantity of the drug during any consecutive ninety-day period;
(viii) notwithstanding the language of this section, nothing shall be interpreted to allow for the sale, trade or exchange of a controlled substance as defined by article thirty-three of the public health law; and
(ix) the sale/transfer price of any item exchanged under this section may not exceed one hundred percent of the item's Wholesale Acquisition Cost (WAC) at the time of the sale. (c) A pharmacy that receives notification from an unregistered nonresident establishment that a delivery or trade involved a drug or device salable on prescription only that is an illegitimate, recalled, or counterfeit product shall immediately notify the state board of pharmacy, and the FDA.
(d) Any unregistered nonresident establishment involved in a sale, exchange, or transaction under this section is subject to the jurisdiction of the state of New York regarding said sale, exchange or transaction. Such establishment shall cooperate with agents of the state of New York if said agent is conducting an audit or investigation into the sale, exchange or transaction, and violations of this section shall be punishable according to regulations promulgated by the department and the laws of this state.
(e) For purposes of this subdivision "specific patient need" is defined as the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need in accordance with the federal Drug Supply Chain Security Act.
§ 3. This act shall take effect on the ninetieth day after it shall have become a law; provided that section two of this act shall take effect on the same date and in the same manner as chapter 491 of the laws of 2024 takes effect.
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, in relation to the registration of nonresident pharmacies, manufacturers, wholesalers and outsourcing facilities that deliver prescription drugs to other establishments, authorized prescribers and patients residing in this state
Purpose
This bill would authorize pharmacies to receive prescription drugs from other pharmacies outside of New York that are not registered with the New York State Education Department, guaranteeing patient access to medications in the case of a public health emergency.
Summary of provisions
Section 1 amends New York State Education Law by adding a new section 6808b that would permit unregistered pharmacies from outside New York to ship, mail or deliver prescription drugs to pharmacies in-state in cases of a specific patient need or a declared public health emergency. This authorization is on the condition that said pharmacies are appropriately licensed within their home states and adhere to additional documentation requirements.
Section 2 sets the effective date.
Justification
The outbreak of the COVID-19 pandemic disrupted pharmaceutical supply chains across the state, hindering patient access to vital drugs. To safeguard the needs of state residents, Governor Andrew Cuomo issued executive order 202.15 which allowed New York pharmacies to exchange medications with other unregistered pharmacies located out-of-state. Subsequently, thousands of transactions have occurred among pharmacies, allowing New York residents to maintain access to prescription medica- tions amid a public health crisis. This bill is needed to codify the Governor's executive order and provide long-term security to pharmacies and patients.
This bill would secure patient access to prescription medications during the ongoing COVID-19 pandemic as well as any future public health emer- gencies. Also, it would reduce pharmaceutical waste by allowing small and independent pharmacies to sell excess medication that would other- wise expire. Many states across the country have adopted similar legis- lation, leaving New York behind in ensuring reliable access to prescription medications. Cementing the ability of New York pharmacies to exchange prescription drugs with other pharmacies outside of the state, not registered with the Education Department, would protect the health of all New York residents and update New York law to reflect a new national standard.
Legislative history
2022: S9448 - Passed both houses; Vetoed Memo.176.
2023: S982 - Passed Senate; Reported and committed to Rules. 2024: S982 - Referred to Higher Education.
Fiscal implications
To be determined.
Effective date
This act shall take effect ninety days after becoming law.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.