Controlled Substances
NY-ADR
11/14/18 N.Y. St. Reg. HLT-46-18-00015-E
NEW YORK STATE REGISTER
VOLUME XL, ISSUE 46
November 14, 2018
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
EMERGENCY RULE MAKING
I.D No. HLT-46-18-00015-E
Filing No. 1048
Filing Date. Oct. 30, 2018
Effective Date. Oct. 30, 2018
Controlled Substances
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of section 80.3 of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 3307(5)
Finding of necessity for emergency rule:
Preservation of public health.
Specific reasons underlying the finding of necessity:
On September 28, 2018, the Drug Enforcement Administration recently issued a final order placing certain drug products that have been approved by the U.S. Food and Drug Administration (FDA) and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act. Specifically, the order places FDA-approved drugs containing CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V. These FDA-approved CBD products have been found to be effective for the treatment of seizures associated with severe and dangerous forms of epilepsy that are notoriously treatment-resistant. This regulatory amendment is necessary to immediately reclassify these products as schedule V substances. This will allow patients in New York state to be prescribed these medications as soon as possible. Any delay in reclassifying these FDA-approved products containing CBD would limit access to these medications and could put patients at risk.
Subject:
Controlled Substances.
Purpose:
To reclassify cannabidiol (CBD) from a Schedule I controlled substance to a Schedule V controlled substance.
Text of emergency rule:
Paragraph (b) of Section 80.3 is amended to read as follows:
(b) Reclassifications.
(1) The following drugs listed in schedule II(c) of section 3306 of the Public Health Law are hereby reclassified as schedule III substances.
* * *
(2) The following drug classified under schedule I of section 3306 of the Public Health Law is hereby reclassified as a schedule V substance:
a drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.
This notice is intended
to serve only as a notice of emergency adoption. This agency intends to adopt this emergency rule as a permanent rule and will publish a notice of proposed rule making in the State Register at some future date. The emergency rule will expire January 27, 2019.
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of Program Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: [email protected]
Regulatory Impact Statement
Statutory Authority:
The Commissioner of Health is authorized pursuant to Section 3307(5) of the Public Health Law (PHL) to reclassify, by regulation or emergency regulation, any compound, mixture or preparation containing any substance listed as a schedule I substance, to a schedule II, III, IV or V substance, if that same compound, mixture or preparation is redesignated or rescheduled other than under schedule I under the federal Controlled Substance Act, or deleted under the federal Controlled Substances Act.
Legislative Objectives:
Section 3307(5) of the Public Health Law permits the Commissioner to respond quickly and flexibly to actions by the U.S Drug Enforcement Agency (DEA) that reclassify scheduled substances, particularly in circumstances where a new medical use of a scheduled substance has been approved by the U.S. Food and Drug Administration (FDA) and is permitted as a result of the reclassification. The purpose of this statute is to ensure that patients in New York can have access to medication that would otherwise be prohibited under the Public Health Law.
Needs and Benefits:
On September 28, 2018, the DEA issued a final order placing certain drug products that have been approved by the U.S. Food and Drug Administration (FDA) and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act. Specifically, the order places FDA-approved drugs containing CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V. These FDA-approved CBD products have been found to be effective for the treatment of seizures associated with severe and dangerous forms of epilepsy that are notoriously treatment-resistant. This regulation is necessary to immediately reclassify these products as schedule V substances, allowing patients in New York state to be prescribed these medications as soon as possible.
Costs:
Costs to the Regulated Entity:
The Department of Health (Department) does not anticipate any additional costs to regulated entities.
Costs to Local Government:
This regulation does not require local governments to perform any additional tasks; therefore, it is not anticipated to have an adverse fiscal impact.
Costs to the Department of Health:
The Department does not anticipate any additional costs.
Local Government Mandates:
This amendment does not impose any new programs, services, duties or responsibilities on local government.
Paperwork:
The department does not anticipate any change in required paperwork by the adoption of this amendment.
Duplication:
No relevant rules or legal requirements of the State government duplicate or conflict with this rule. The amendment reflects federal reclassification of FDA approved cannabidiol substances.
Alternatives:
An alternative to this regulatory amendment would be to not reclassify FDA-approved cannabidiol products as schedule V controlled substances. However, by not reclassifying these FDA approved drugs, patients in New York state would not be able to benefit from these medications.
Federal Standards:
The DEA, on September 28, 2018, reclassified FDA approved cannabidiol products as schedule V substances. This regulatory amendment would reflect that change.
Compliance Schedule:
There is no compliance schedule imposed by these amendments, which shall be effective upon filing with the Secretary of State.
Regulatory Flexibility Analysis
No regulatory flexibility analysis is required pursuant to section 202-b(3)(a) of the State Administrative Procedure Act. The regulation does not impose an adverse economic impact on small businesses or local governments, and it does not impose reporting, record keeping or other compliance requirements on small businesses or local governments.
Rural Area Flexibility Analysis
A Rural Area Flexibility Analysis for these amendments is not being submitted because amendments will not impose any adverse impact or significant reporting, record keeping or other compliance requirements on public or private entities in rural areas. There are no other compliance costs imposed on public or private entities in rural areas as a result of the amendments.
Job Impact Statement
A Job Impact Statement for these amendments is not being submitted because it is apparent from the nature and purposes of the amendments that they will not have a substantial adverse impact on jobs and/or employment opportunities.
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