Diet Pills: Legal consequences

Last modified: Sunday, 31. May 2009 - 1:27 pm

Legal consequences of Diet Pills

The federal government regulates prescription diet pills in several ways. Some drugs are classified as controlled substances; all drugs are regulated by the Food and Drug Administration (FDA). The FDA determines whether a new drug can be manufactured or if production should be halted on a drug currently on the market.

Legal history

The federal Food, Drug, and Cosmetics Act of 1938 gave regulatory powers to the FDA. Pharmaceutical companies apply to the FDA for approval to manufacture a new drug. The approval process includes research, testing, and hearings. Once a drug is approved, the FDA determines whether a prescription is required.
FDA regulations about prescription drugs also apply to how the manufacturer promotes or advertises the medications. Unless specified by other regulations such as the Controlled Substances Act (CSA), there are no restrictions on what condition the doctor prescribes the pill for, the dosage, or the amount of time that the patient will take the pill.
Controlled substances. The Controlled Substances Act (CSA) portion of the 1970 Comprehensive Drug Abuse Prevention and Control Act classified drugs in five categories based on the effect of the drug, its medical use, and potential for abuse. Schedule I contains drugs like heroin, which have no medical use but may be used in research. It is the most tightly controlled category.

Federal guidelines, regulations, and penalties

The CSA classifies the methamphetamine Des-oxyn as a stimulant. Anorectic drugs, the diet pills developed to replace amphetamines, are regarded by the government as controlled substances. While these drugs are not as powerful as amphetamines, their effects are similar.
Schedule II drugs. Schedule II drugs have a high potential for abuse. They are accepted for medical use with restrictions. These drugs may lead to severe psychological or physical dependence, according to the CSA. Desoxyn is a Schedule II drug. Dexedrine, the popular diet pill of the 1950s, is also in this category. It is no longer prescribed for weight loss. A prescription is required for these drugs, and it cannot be refilled.
Schedule III drugs. Schedule III drugs have less of a potential for abuse than drugs in Schedules I and II. The drugs have a medical use. Abuse of these drugs may lead to “moderate or low psychological dependence or high psychological dependence,” according to the CSA. Anorectics in this category are benzpheta-mine (Didrex) and phendimetrazine (Bontril, Plegine, and Prelu-2). A prescription may be filled up to five times during the six months after the first prescription was written.
Schedule IV drugs. Schedule IV drugs have a low abuse potential as compared to Schedule III drugs. These substances have an accepted medical use. They could lead to limited psychological or physical dependence, according to the CSA.
The anorectic drugs in this category are phenter-mine (Ionamin, ApidexP), diethylpropion (Tenuate, Tepanil), and mazindol (Mazanor, Sanorex). Sibu-tramine (Meridia) is also in this category. The withdrawn drugs dexfenluramine (Redux) and fenfluramine (Pondimin) were also in this category.
In Schedule IV, five prescription refills are allowed during the six months after the patient received the first prescription.
Other diet pills. Other diet pills are classified in various ways. Orlistat (Xenical) is not classified as a controlled substance. A prescription is required.
Over-the-counter diet pills are classified as Schedule V drugs. Medications in this category have the lowest potential for abuse, have an accepted medical use, and a limited potential for physical or psychological dependence.
Penalties. Federal law prohibits the possession, use, and distribution of illegal drugs. This law applies to diet pills obtained without a prescription. The Controlled Substances Act established tighter controls on the manufacture and distribution of drugs like diet pills. Limits were set on the amounts of Schedule II pills that could be manufactured.
Procedure for the legal distribution of pills includes the requirement of a written prescription for Schedule II drugs. An exception is made in emergencies.
For Schedule III and IV drugs, the prescription may be written or called into the pharmacy. Both the health care practitioner and pharmacist are required to keep records when prescriptions are filled for controlled drugs.
Trafficking. Trafficking is the illegal distribution of controlled drugs. Federal penalties for this crime can include fines and imprisonment. Sentencing is based on factors such as whether the trafficker is a first-time offender. Penalties are higher for a second offense. In addition, if the illegal distribution of a Schedule II drug results in death or serious injury, the convicted offender faces a prison term of from 20 years to life.
In cases where there is no serious injury or death, the penalties for a first-time offense are:
• Schedule II: Trafficking 100 grams or more of methamphetamine carries a prison term of from 10 years to life and a fine of up to $4 million.
• Schedule III drugs: Trafficking any quantity of these drugs is punishable by up to five years in prison and a maximum fine of $250,000.
• Schedule IV drugs: Illegally distributing any quantity of these drugs carries a prison term of up to three years and a fine of up to $250,000.
Penalties for drug abusers. The federal penalty for the first-time offense of illegally possessing a controlled substance is up to one year in prison and a fine of from $1,000 to $100,000. Penalties are generally doubled for a second offense.
In some cases, a person may not receive a prison sentence. The Anti-Drug Abuse Act of 1988 imposes a civil penalty on the minor drug offender, the person possessing a small quantity of an illegal controlled substance. Possession of this quantity known as a “personal use amount” carries a fine of up to $10,000.

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