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.
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:
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
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: