Pharmacy Law Newsletter
Editor: Karl Fiebelkorn, MBA, RPh
Pharmacy Law Newsletter is an online website from the University at Buffalo School of Pharmacy and Pharmaceutical Sciences, covering pharmacy practice laws in New York State.
Pharmacy Law Newsletter was created in 1993 by the late Robert M. Cooper, PharmD, a long-time UB faculty member and a member of the New York State Board of Pharmacy. It was his dream to bring current, concise and accurate information to practicing pharmacists.
Pharmacy Law Update 2021
Sunday, October 24, 2021
6:00 – 9:00 p.m.
Karl D. Fiebelkorn, RPh, MBA
Senior Associate Dean for Student, Professional, and Community Affairs, Department of Pharmacy Practice, University at Buffalo School of Pharmacy and Pharmaceutical Sciences
3 Contact Hours (0.3 CEU)
All practicing pharmacists, technicians and students
At the completion of this activity, the participant will be able to:
- List upcoming legislative issues and their potential effect on pharmacy practice.
- Summarize recent changed in the Federal and NYS controlled substance acts.
- Outline the new changes in pharmacy personnel and technicians.
- Describe Health and Human Services PREP Act and the impact on pharmacy practice.
- Define the laws and regulations governing the sale of cannabinoid hemp by pharmacists in NYS.
- Discuss changes in the pharmacy practice in NYS.
- $25.00 for PSR/PAWNY Members
- $50.00 for PSSNY/NYASCP/NYSCHP
- $75.00 Non Members
- $10.00 Students/Pharmacy Technicians
- All registrants must have a CE account set-up with the University at Buffalo School of Pharmacy and Pharmaceutical Sciences Continuing Education Office. Visit www.pharm.buffalo.edu/ce and follow registration instructions.
- The University at Buffalo School of Pharmacy and Pharmaceutical Sciences is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program has been accredited as knowledge-based activity.
- Credit will be uploaded to the CPE Monitor to those whose attendance is documented and complete all program components. To receive credit for this program participants must sign into the online program with first and last name.
COVID-19 Vaccination Information
Legislative Bills of Interest: New York State
- Pharmacist’s Manual:
- The Drug Enforcement Agency has posted a new version of the DEA Pharmacist’s Manual for 2020: 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-046)(EO-DEA154)_Pharmacist_Manual.pdfDownload pdf
- DEA Drug Take Back Day 2020:
- 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 pdf of the poster may be found hereDownload pdf. Further information may be found from the NYS Department of Environmental Conversation.
Erie County Ban on Tobacco Sales in Pharmacies
Oxana Lypska, PharmD Candidate 2021
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:
- 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.
- 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.
- 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.
DEA Proposes Quotas on Controlled Substances for 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:
- The total net disposal by all manufacturers during the current and two years preceding the year in question.
- Trends in the national rate of disposal
- Total actual, or estimated inventories of all substances or chemicals manufactured in the class and any inventory accumulations
- Projected demand, which has dropped recently according to the DEA
- 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.
Pharmacies Now Required to Provide Patients with Information about Controlled Substance Prescriptions
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:
The Legal Stuff
© 2021 by the Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any mechanical or electronic means—photocopying, recording, or otherwise—without the prior permission, in writing, of the publisher.
Pharmacy Law is published as an educational service to the pharmacy community in New York State. Its sole purpose is to promote an understanding of the laws, rules, and regulations that affect the practice of pharmacy in New York. Because Pharmacy Law is a periodical about legal issues, the information is subject to change with little or no notice. The law is dynamic, and discrete facts should be verified before they are relied upon. Pharmacy Law is intended to inform, but not to provide legal advice. For specific legal problems, readers should seek legal counsel. The publisher, editor, advisory board, authors, and University at Buffalo do not hold themselves out as offering legal advice.