Pharmacy Law Newsletter

Effective September 9, 2022, New York State Governor Kathy Hochul issued an Executive Order concerning the polio virus and pharmacist responsibilities.  Executive Orders in New York State are valid for 30 days and must be re-issued every 30 days; otherwise, they become null and void. 

• Authorizes pharmacists, midwives and Emergency Medical Services (EMS) personnel to administer the polio virus vaccine pursuant to a non-patient specific standing order.
• Allows physicians and certified nurse practitioners to issue non-patient specific standing orders for vaccines; and 
• Requires such vaccine providers to report adult (19 and older) polio vaccines to the New York State and New York City vaccine registries (New York State Immunization Information Systems (NYSIIS) and Citywide Immunization Registry (CIR)) within 72 hours of administration, waiving adult consent requirements to do so.
• Effective September 9 – October 8, 2022.
  

Pharmacists are reminded to update their standing order and make sure their blood borne pathogen and CPR trainings are current.  

Effective August 28, 2022, New York State Governor Kathy Hochul issued an Executive Order continuing the delcaration of a statewide disaster emergency concerning the ongoing spread of the Monkeypox Virus and pharmacist responsibilities.  Executive Orders in New York State are valid for 30 days and must be re-issued every 30 days; otherwise, they become null and void. 

• Authorizes pharmacists, midwives and Emergency Medical Services (EMS) personnel to administer the monkeypox vaccine pursuant to a non-patient specific standing order.
• Allows physicians and certified nurse practitioners to issue non-patient specific standing orders for vaccines; and 
• Requires such vaccine providers to report adult (19 and older) monkeypox vaccines to the New York State and New York City vaccine registries (New York State Immunization Information Systems (NYSIIS) and Citywide Immunization Registry (CIR)) within 72 hours of administration, waiving adult consent requirements to do so.
• Effective August 28 - September 27, 2022.

Pharmacists are reminded to update their standing order and make sure their blood borne pathogen and CPR trainings are current.  

• Blanket waivers allowed through March 24, 2023:
  • Letter from the NYS Commissioner of Health to practitioners and pharmacists regarding a blanket waiver for additional exceptional circumstances related to electronic prescribing – March 14, 2022
• Blanket waivers allowed through October 31, 2022:
  • Letter from the NYS Commissioner of Health to practitioners and pharmacists regarding a blanket waiver of the electronic prescribing requirements for nursing homes and residential health care facilities – October 29, 2021

• Pharmacist’s Manual: 
  • The Drug Enforcement Agency has posted a new version of the DEA Pharmacist’s Manual for 2022:  An Informational Outline of the Controlled Substances Act. This manual, prepared by the DEA Diversion Control Division, outlines pharmacists’ responsibilities in regard to the Federal Controlled Substances Act.  When perusing this manual, pharmacists practicing in New York State (NYS) are reminded that the strictest law applies.  

This manual may be found at https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist's_Manual_DEA.pdf

• Drug Disposal: 
  • National Prescription Drug Take Back Day
  • DEA National Prescription Drug Take Back Day took place on October 24, 2020 with more than 980,000 pounds of medication destroyed that was collected from more than 4,500 designated sites throughout the United States.  In addition to the DEA’s National Prescription Drug Take Back Day, consumers may dispose of their household medications at any of the 11,000 DEA-approved collectors throughout the year. 
  • Pharmacists are reminded that there are other methods of disposal for their patients who may be homebound, without the patient having to leave their home.  The Food and Drug Information contains information on how to dispose of unwanted medications.  Pharmacies in NYS are required to post a notice to educate patients on proper drug disposal, a copy of the poster may be found here.  Further information may be found from the NYS Department of Environmental Conversation.

In a continued effort to protect the public from the dangers of smoking, Erie County and New York City passed laws in 2018 prohibiting smoking in certain areas, as well sales of tobacco products in pharmacies. Erie County’s Public Health Protection Act of 2018 designated a series of new rules that will increase protection of children against secondhand smoke, and expand the prohibition of smoking. The tenets of this Act include the following:

1. Smoking of tobacco products in motor vehicles when children are present will be prohibited. Knowing violation of this rule will result in fines of $50 for the first offense, $100 for the second offense, and $150 for the third offense.
2. Smoking in or near bus shelters will be prohibited, with knowing offenses punishable by fines of $50 for the first offense, $100 for the second offense, and $150 for the third offense.
3. The sale of tobacco products or e-cigarette products in healthcare institutions and pharmacies will be prohibited. A violation of this rule will result in a civic penalty of $300 to $1000 for the first offense, and $500 to $2000 for any additional violations.

This local law takes effect immediately upon being filed with the New York State Secretary of Health. A grace period of 90 days will be in effect after the Act is signed into law, during which only warnings will be given and fines will not be imposed.

Additionally, New York City amended Title 20, Chapter 2, § 20-201 of the Administrative Code of NYC, which may be accessed here. The change deems it unlawful for a pharmacy to obtain a license to sell tobacco products and engage in business as a retail dealer. This law took effect on January 1, 2019.

A final order was published in the Federal Register Volume 83, Number 248 on December 28, 2018 concerning the Drug Enforcement’s Quota reduction for 2019. This final order establishes the initial 2019 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Aggregate production quotas for Schedule I and II drugs and List 1 chemicals are determined for the estimated medical, scientific, research and industrial needs domestically, for lawful export requirements and for maintenance of reserve stocks. The DEA considers:

1. The total net disposal by all manufacturers during the current and two years preceding the year in question.
2. Trends in the national rate of disposal
3. Total actual, or estimated inventories of all substances or chemicals manufactured in the class and any inventory accumulations
4. Projected demand, which has dropped recently according to the DEA
5. Any other factors affecting the medical, scientific, research and industrial needs in the US and the lawful exports of the drug.

The purpose of the quotas are to provide the uninterrupted supply for legitimate medical needs of Schedule I and Schedule II controlled substances while limiting the amounts available to prevent diversion.

Established quotas for 2019 may be found in this Federal Register, which may be located at https://www.deadiversion.usdoj.gov/fed_regs/quotas/2018/fr1228.htm.

As of October 22, 2016, pharmacies are now required to give information to the patient about any controlled substance prescription that is being dispensed. This information is provided by the NYS Office of Alcoholism and Substance Abuse Services (NYS OASAS) and the NYS Department of Health Bureau of Controlled Substances (BNE) and must include the “…dangers of misuse and the potential for addiction to prescription controlled substances, the physical and behavioral warning signs of addiction, treatment resources available and the proper way to dispose of unused prescription controlled substances…”  among other items. The pharmacy may provide additional information and resources for the safe disposal if so desired. 

Further, this information must be provided in languages other than English as deemed appropriate by the NYS Commissioner of Health (up to the 10 most common languages in NYS). Pharmacies may provide this information to the patient electronically if so requested by the patient. Please see the following important documents: