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.
A comprehensive lecture series to review the laws, rules and regulations concerning pharmacy practice in NYS.
More information will be available by March 1.
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:
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:
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: