Delaware News: Controlled Substance Issues

Topics: Controlled substances

Published in the September 2009 Delaware State Board of Pharmacy Newsletter

Refilling Controlled Substance Prescriptions Early
The Board office has recently had numerous calls related to the early refilling of controlled substance prescriptions. There is no easy way to determine how early a controlled substance refill may be filled. Patients have a host of events that would require early refills including, but not limited to, vacations, medication loss, and waste. However, when the request for an early refill begins to be a routine, the pharmacist should contact the practitioner to alert them of the patient’s reasoning for early filling and to ensure the practitioner’s knowledge of the repeated event. Documentation of the practitioner contact should be kept on file. A pharmacy-written policy and procedure including proper documentation of the handling of the early refill is suggested.


Controlled Substance Regulations
After due notice in the Register of Regulations and two Delaware newspapers, public hearings were held on March 11, 2008, and October 20, 2008, to receive comments regarding proposed amendments to the Controlled Substance Regulations including the creation of a Controlled Substance Advisory Committee and further clarification of identification relevant to controlled substance prescriptions. The proposed regulations were first published in the Register of Regulations on February 1, 2008, at 11 DE Reg. 1082. The March 11 hearing was noticed in the Register of Regulations on March 1, 2008, at 11 DE Reg. 1269. As a result of the public comment, and upon the recommendation of the director, the Secretary of State determined to make both substantive and nonsubstantive revisions to the proposed regulations, and republished the regulations in the Register of Regulations on September 1, 2008, at 12 DE Reg. 301. A second public hearing was noticed for and conducted on October 20, 2008.
The purpose of the committee is to advise the Secretary of State on controlled substance regulatory matters and to conduct hearings related to registrants. The committee regulates by registering prescribers, dispensers, manufactures, distributors, clinics, researchers, and other controlled substance registrants (ie, a dog handler). Among its functions, the committee issues and renews licenses and makes recommendations to the Secretary of State of new or amended controlled substance regulations and disciplinary actions of registrants who violate the law. (16 Del.C. §4700 to the end)
To review the controlled substance regulations in their entirety, please visit www.dpr.delaware.gov.