FDA Guidelines

Pharma IQ
Posted: 09/19/2010

The pharmaceutical industry in the United States has to comply with a number of guidelines to ensure the quality of the products it manufactures, the safety of its workers and members of the public, and the environment in which it operates.

Many of these are issued by the Food and Drugs Agency (FDA), which exists to protect the public's health by ensuring all foods and medical products used by humans are safe. Products covered by FDA guidelines include drugs, biological products, medical devices, foods, cosmetics and devices that emit radiation.

Rules issued by the organisation cover the whole spectrum of the pharmaceuticals industry, from those governing clinical trials,which are used to establish the safety of new drugs, to those that dictate how the products can be advertised once they make it to market.

FDA guidelines guidelines for medical devices are administered by the Center for Devices and Radiological Health and cover all those involved in the manufacturing, repackaging and import of such devices in the United States. FDA guidelines for pharmaceuticals include regulations on good manufacturing practice and good clinical practice which ensure that safety is at the heart of all drug development.

EPA guidelines

EPA guidelines (Environmental Protection Agency) are there to ensure the correct disposal of certain drugs classified as hazardous waste. Some 31 commercial chemical products fall under regulationsfor hazardous waste, a number of which are used in chemotherapy treatments. Many of these drugs are detailed on the EPA's U list and P list.

To be classed as hazardous waste, a drug must display one of four qualities; ignitability, corrosivity, reactivity or toxicity.

The disposal of prescription drugs is also covered by EPA guidelines, which were created in conjunction with the Office of National Drug Control Policy and the FDA. Under the guidelines, no drugs should be flushed down a drain unless the packaging specifically specifies this as a method of disposal.

Additional guidelines

OHSA guidelines (Occupational Safety and Health Administration) also exist for those involved in the handling of chemicals.

Those working with drugs which contain potentially hazardous substances should have engineering controls, administrative controls, personal protective equipment and the correct training.

Antineoplastic cytotoxic medications, anaesthetic agents and anti-viral agents,among others, have all been classed as hazardous under OSHA guidelines.

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Pharma IQ
Posted: 09/19/2010

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