Controlled Substance: Understanding the Classification and Regulation of Drugs

Classification of Controlled Substance

The Controlled Substance Act (CSA) divides drugs and other substances into five schedule categories or schedules based on a substance's medical use, potential for abuse, and safety or dependence liability. The schedules are as follows:

Schedule I substances have no currently accepted medical use and a high potential for abuse. Examples include heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.

Schedule II substances have a high potential for abuse which may lead to severe psychological or physical dependence. Examples include oxycodone (OxyContin®), hydrocodone (Vicodin®), cocaine, methamphetamine (Desoxyn®), methadone, fentanyl, and Dexedrine®.

Schedule III substances have less abuse potential than Schedule I or II drugs but more than Schedule IV drugs. Examples include products containing less than 90 mg of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone, and some buprenorphine containing products.

Schedule IV substances have a low potential for abuse and low risk of dependence. Examples include alprazolam (Xanax®), clonazepam (Klonopin®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and tramadol (Ultram®).

Schedule V substances consist of preparations containing limited quantities of certain narcotics. Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, Phenergan with Codeine®).

Regulating Access to Controlled Substance

In order to legally handle Controlled Substance, one must have a Drug Enforcement Administration (DEA) registration or be authorized to prescribe, dispense, or conduct research under the supervision of a DEA registrant. Physicians, dentists, veterinarians, physician assistants, nurse practitioners with appropriate qualifications, and other practitioners who wish to prescribe, dispense, or administer Controlled Substance must obtain a DEA registration and comply with DEA regulations regarding recordkeeping, reporting, storage, and security.

The CSA also governs the manufacture, importation, exportation, distribution, and dispensing of Controlled Substance. Regulations establish a closed system of distribution for recordkeeping and ordering quotas are imposed on the availability and production of Controlled Substance. Manufacturing/distribution facilities, reverse distributors, analytical labs and physicians/researchers must register with the DEA to engage in these activities. Importers and exporters must also obtain annual DEA import/export permits in addition to the registrations.

Enforcement of Controlled Substance Laws

Penalties for violating controlled substance laws depend on the schedule of the drug in question and other factors but can include significant fines and prison time. For example, possession of small amounts of marijuana is typically a misdemeanor offense but possession of larger quantities or intent to distribute can be a felony. Trafficking or manufacturing certain drugs like heroin, cocaine, methamphetamine, or fentanyl generally carry stiff mandatory minimum sentences due to their highly addictive nature and association with violent crimes.

The DEA investigates violations related to Controlled Substance along with other law enforcement agencies. Tactics may involve undercover operations, confidential informants, wiretaps, raids, and surveillance. Prosecutors bring cases under both federal and state controlled substance laws, depending on the jurisdiction and nature of the alleged criminal activity. Substances prohibited by the CSA are similarly outlawed under complementary state controlled substance acts.

Monitoring Controlled Substance Prescriptions

In recent decades, policymakers and health officials have taken steps to curb problems with prescription drug abuse and diversion. All 50 states now operate prescription drug monitoring programs (PDMPs) that track prescriptions for Controlled Substance dispensed by pharmacies. Doctors and pharmacists can access PDMP data to identify "doctor shoppers" obtaining narcotics from multiple sources. Some states have also placed limits on dosages and durations for opioid prescriptions following surgeries and acute injuries.

Insurers have curtailed coverage for early prescription refills as well. The CSA was amended via the Ensuring Patient Access and Effective Drug Enforcement Act to require DEA orders that restrict certain prescription drugs be based on "imminent danger to public health or safety." This prevents abrupt enforcement actions against physicians dispensing Controlled Substance in the usual course of professional practice. Overall, the goal is to prevent overprescription and diversion while still ensuring patients have adequate access to medications for legitimate medical needs.

Controlled Substance and Public Health

While controlled substance laws aim to curb abuse, there is no doubt these regulations also affect those with medical necessity and their healthcare providers. The balancing act between access and control remains an ongoing challenge, especially during times when an "opioid epidemic" is rightly garnering public awareness and policy action. The overarching purpose of the Controlled Substance Act and related state and federal statutes is to protect health, safety, and welfare - though reasonable minds can disagree on where to strike the right balance.

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