Over-the-Counter Drugs - The Law

The Law

OTC drugs are often the subject of research studies and make news headlines when people experience problems when taking certain drugs. Here's a look at some past and recent issues involving OTC drugs and the law.

Product Tampering

It is against the law to tamper with the packaging of any OTC medicine in order to change its ingredients or misrepresent its contents. Anyone who purchases an OTC preparation and finds the box open or the safety seals removed should return the medicine to the place of purchase immediately and report the discovery to both the store and the police.

A worker is shown checking new bottles of the over-the counter painkiller Tylenol in 1982. The bottles feature tamper-resistance packing, which was new at that time. The safety seals were added after seven people in the Chicago area were killed
A worker is shown checking new bottles of the over-the counter painkiller Tylenol in 1982. The bottles feature tamper-resistance packing, which was new at that time. The safety seals were added after seven people in the Chicago area were killed when they took Tylenol that had been poisoned with cyanide. © Leif Skoogfors/Corbis.

Product tampering became a major issue in the early 1980s when someone poisoned several bottles of Tylenol capsules with cyanide. Several people in the Chicago, Illinois, area purchased the capsules and later died after taking the tainted pills. It was believed that someone had tampered with the bottles on the store's shelves. This tragedy led the makers of Tylenol and other products to create new safety seals—special wrappings placed securely over bottle tops, boxes, and other packaging that will clearly show any evidence of tampering. If the safety seal is broken, customers are advised to return the product to the store.

Intoxication

The word intoxication is most often used when describing someone who is drunk. When intoxicated, people lose physical and mental control. For example, their speech becomes slurred, they can't operate their cars safely, and they don't think clearly. Drugs, both legal and illegal, can cause intoxication, too. Individuals who abuse OTC drugs and cause crashes or injuries while under the influence of such drugs face charges similar to those imposed for driving drunk.

Over the Counter or Behind It?

As of 2005, some "over-the-counter" medications were being reclassified as "behind-the-counter" medications because of growing patterns of their misuse. The U.S. government had not yet passed any laws against possession of dextromethorphan by the summer of 2005, even though the OTC ingredient has been linked to recreational substance abuse. Some large chain pharmacies have placed cold, cough, and allergy medicines containing dextromethorphan behind the counter. Other stores require proof of age before the product can be purchased. If recreational abuse of dextromethorphan continues or becomes more widespread, the FDA may decide to reclassify it as a prescription-only medicine.

Pseudoephedrine, the active ingredient in over-the-counter cold medicines such as Sudafed, caused a considerable legal stir in 2005. More and more states sought to limit sales of pseudoephedrine because it is used in the manufacture of the highly addictive drug methamphetamine. Pseudoephedrine became a "behind-the-counter drug" in more than a dozen U.S. states.

However, in August of 2005, Oregon became the first state to take it one step further. Oregon lawmakers introduced and passed a bill that would make cold and allergy medications containing pseudoephedrine available by prescription only. This action came after Oregon representatives put the "behind-the-counter" system to the test. According to Charles E. Beggs in an article on KGW.com, Northwest NewsChannel 8, Democratic representative Greg MacPherson and three of his colleagues "shopped for cold medicines … and easily bought enough in an hour to make several weeks' supply of meth for four users." Oregon's groundbreaking bill is scheduled to go into effect in mid-2006.