HCP's and Diversion Control Security Requirements

Posted by Safe & Vault on Sep 08, 2014

The Federal Drug Administration of the United States of America uses a scheduling classification system to differentiate prescription (and over-the-counter) drugs available in the United States. These drugs are separated into five different classes (or Schedules) from Schedule I to Schedule V, with Schedule I being the drugs with the highest potential for physical and chemical dependence, and Schedule IV being the drugs with little to no potential for dependence or abuse. Very rarely are drugs moved from one Schedule to another, and nearly never is a drug moved from a lower Schedule to a higher Schedule. This is exactly the case that is now presenting itself with regard to hydrocodone, and hydrocodone combined products (HCPs). With prescriptions exceeding 139 million per year, HCPs are one of the most used and abused drugs in the United States today. While there are many legitimate uses for HCPs, they are also extremely addictive and frequently abused by those who are acquiring the drug via prescription, or through other less legal avenues. Hydrocodone and HCPs possess addictive effects similar to morphine in both humans and animals. Data collected by the Federal Drug Enforcement Agency (DEA) demonstrated by HCPs have an abuse potential similar to other Schedule II opioid analgesics, such as morphine and oxycontin. With regards to hydrocodone and HCPs, Schedule III drugs have moderate to low abuse potential, while those in Schedule II have a high potential for abuse. Hydrocodone was listed as a Schedule III drug when the Controlled Substances Act (CSA) was enacted in 1971. Drugs that contained no greater than 15 mg hydrocodone per dose, or not more than 300 mg per 100 ml were covered in this Schedule. In 2004, the Assistant Secretary for Health of the Department of Health and Human Services petitioned the DEA pursuant to 21 CFR 1308.43 to perform a re-evaluation of HCPs with regard to current levels of use and addiction.  If approved, HCPs would be moved to Schedule II with regard to the administrative, civil, and criminal sanctions applied to all drugs contained within said schedule. The decision was handed down in 2008 that HCPs remain in a Schedule III classification. in 2009, the decision was re-petitioned, and on July 9th of 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDICIA Pub.L. 112-144). The purpose of this act was to solicit stakeholder input “regarding the health benefits and risks, including potential for abuse” of HCPs. In October of 2013 the Federal Drug Administration approved Zohydro TM ER, which was the first hydrocodone product to be scheduled directly to Schedule II. This caused the need for a ruling to be made with regards to other HCP products in a swift manner. On December 16th, 2013, an evaluation was presented by the DEA stating that there is currently a significant diversion of HCPs, and frequently individuals are taking these drugs on their own initiative rather than under the supervision of a physician. With these being the findings, 21 CFR Part 1308 was enacted. This act solidified the move of hydrocodone and HCPs to Schedule II from Schedule III effective October 6th, 2014.

There will be many affected by the changes in schedule for hydrocodone and HCPs with regard to storage and containment, including those who manufacture, distribute, dispense, import, export, engage in research, conduct instructional research activities, possess, or propose to handle these drugs. Facilities in compliance with Schedule III regulations will find that the requirements for Schedule II drugs are more restrictive than in the prior (higher) class.

Class I and II controlled substances and product are to be stored in accordance with Title 21 of the Code of Federal Regulations Part 1301 as enacted by the DEA. The code specifies that, in the instance of small amounts of drugs permit, a safe or steel cabinet may be used. This safe or cabinet must provide; * 30 man-minutes against surreptitious entry * 10 man-minutes against forced entry * 20 man-hours against lock manipulation * 20 man-hours against radiological techniques

For more information on safes and steel cabinets that meet the DEA Diversion Control security requirements, visit our Controlled Substance Storage Solutions here

The Code also states that if a safe or steel cabinet is less than weights less than 750 lbs., it must be bolted or cemented to the floor in such a way it cannot be removed. Also, depending on the quantities and type of the substances being stored, the safe or cabinet must be equipped with an alarm system which, upon attempted break-in, shall transmit a signal directly to a central protection company or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection.