by Ed Coghlan
The United States Drug Enforcement Administration (DEA) has announced it will reduce the amount of almost every Schedule II opiate and opioid medication that may be manufactured in the United States in 2017.
The reduction will be by 25 percent or more, according to a Final Order being published in the Federal Register tomorrow and available for public inspection today here.
For several other medicines, including hydrocodone, it will be a much larger reduction. The DEA is reducing hydrocodone manufacturing by 2/3rd.
The DEA says that demand for these opioid medicines, represented by prescriptions written by DEA-registered practitioners, has decreased.
The 2015 National Survey on Drug Use and Health (NSDUH) released last month found 6.5 million Americans over the age of 12 used controlled prescription medicines non-medically during the past month, second only to marijuana and more than past-month users of cocaine, heroin, and hallucinogens combined.
Earlier this year the CDC issued guidelines to practitioners recommending a reduction in prescribing opioid medications for chronic pain.
According to the DEA press release, the purpose of quotas is to provide for the adequate and uninterrupted supply for legitimate medical need of the types of schedule I and II controlled substances that have a potential for abuse, while limiting the amounts available to prevent diversion..
The DEA considers data from many sources, including estimates of the legitimate medical need; estimates of retail consumption based on prescriptions dispensed; manufacturers’ data on actual production, sales, inventory, exports, product development needs, and manufacturing losses; data from DEA’s own internal system for tracking controlled substance transactions; and past quota histories. Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those companies that apply for it. DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls.