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Fiebelkorn

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.

The website address pharmacylaw.buffalo.edu is changing! Please refer to pharmacy.buffalo.edu/law for all future information and communication.

Recent Updates

Legislative Bills of Interest

State

Federal

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Governor Extends Emergency Executive Order to March 22, 2018

Governor Extends Emergency Executive Order to March 22, 2018

On January 25, 2018, Governor Cuomo declared a Public Health Emergency in New York State because of this year’s severe flu season.   The Executive Order originally issued on January 25, 2018 gives certified pharmacist immunizers the authority to administer flu vaccines to children between the ages of 2 and 18 years.

In addition, NYS certified pharmacists may secure flu vaccines through the Vaccine for Children Program (VFC) to administer to Medicaid enrolled and uninsured children.  This flu vaccine is provided free of charge by the Centers for Disease Control (CDC) to the VFC and in turn to those pharmacies enrolled in the program.  Specific procedures must be followed to bill for reimbursement for professional services but not the cost of the vaccine when it is obtained through the VFC program free.

During the period that the Executive Order remains in effect, those pharmacies not enrolled in the VFC program, may bill the acquisition cost of the vaccine and the administration.  Professional services must be provided and documented in accordance with the laws and regulations of the NYS Department of Education including specific reporting requirements for patients less than 19 years of age. See: http://www.op.nysed.gov/prof/pharm/pharmimmunizations.htm.

Further details of the Governor’s Emergency Executive Order may be found at https://www.governor.ny.gov/news/governor-cuomo-extends-emergency-executive-order-promote-vaccination-flu-epidemic-continues.

FDA Label Changes for Cough and Cold Products

FDA Label Changes for Cough and Cold Products

On January 11, 2018 the United States Food and Drug Administration issued a requirement for safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone.  These medications should be limited to adults 18 years of age and older because the risks of such medicines outweigh their benefit to children younger than 18.  Safety information about the risks of misuse, abuse, addiction, overdose, death and slowed or difficult breathing will be added to the Boxed Warning of those prescription medicines containing codeine or hydrocodone.

Pharmacists should be aware that those opioid containing cough and cold medicines are no longer indicated or recommended for use in children.  More information may be found at the FDA website: www.FDA.gov.

DEA Proposes Quotas on Controlled Substances for 2018

DEA Proposes Quotas on Controlled Substances for 2018

The Drug Enforcement Administration has proposed a 20% reduction for controlled substances to be manufactured in 2018 as compared to 2017.  The August 7, 2017 Federal Register has reported that the DEA intends to reduce the 2018 production quotas for Schedules I and II of the Federal Controlled Substance Act while assessing the annual needs of the List 1 chemicals:  ephedrine, pseudoephedrine and phenylpropanolamine.  Schedule II drugs slated for reduction quotas include codeine, hydrocodone, hydromorphone, oxycodone, morphine, meperidine and fentanyl.

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.

Since this is a proposed ruling, comments may be submitted up until October 6, 2017 (60 days).  All comments concerning this proposed rule may be sent to the DEA at http://www.regulations.gov and are available for public inspection online.   Revisions to the aggregate quota by the DEA may be warranted during the year if changes occur due to increased sales or exports; new manufacturers entering the marketplace, new product development or product recalls. 

Pharmacies Now Required to Provide Patients with Information about Controlled Substance Prescriptions

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

© 2018 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.