Legal considerations of drugs

Objectives

• Drug standards• Pharmacopoeia• Food, drug and cosmetic act

Why do we need drug standards?

• Neither doctors nor patients are able to decide among the vast number of drugs available, which ones are safe and effective

• Since there could be drug manufacturers who do not meet the proper standards it is essential to monitor the drugs in the market

• This is a responsibility of the government of each country

Drug standards

• Drugs of the same name must have the same strength, quality, and purity

• All medicines marketed should be licensed by the government

Drug license …

• License is granted after the scientific evaluation of

-safety-efficacy-qualityA license should specify the clinical indication of the

drug A license is only for a limited period (ex- 5 yrs) and

renewable there after

When were drug standards implemented?

• Starting from the early 20 th century laws and legislations were formed to maintain drug standards. Ex-

• 1906 Pure Food & Drug Act• 1914 Harrison Narcotic Act

A story….• In 1937, S. E. Massengill Company, a pharmaceutical manufacturer,

created a preparation of sulfanilamide using diethylene glycol (DEG) as a solvent, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this (although it was known at the time). Watkins simply added raspberry flavoring to the sulfa drug which he had dissolved in DEG and the company then marketed the product.

• The company started selling and distributing the medication in September 1937. By October 11, the American Medical Association received a report of several deaths caused by the medication. The Food and Drug. At least 100 deaths were blamed on the medication.

• Congress responded to public outrage by passing the 1938 Food, Drug, and Cosmetic Act, which required that companies perform animal safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their products.

• Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisoning crisis.

1938 Food, Drug and Cosmetic Act

a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics

The act has been amended many times, most recently to add requirements about bioterrorism preparations.

1938 Food, Drug and Cosmetic Act

• This replaced the 1906 pure drug and food act

1938 Food, Drug and Cosmetic Act-contents

• definition for a food• definition for a drug • Definition for a medical device • definition of a food additive• definition of a dietary supplement

1938 Food, Drug and Cosmetic Act-contents

• Prohibited Acts and Penalties- This section contains both civil law and

criminal law clauses. Most violations under the act are civil, though repeated, intentional, and faking violations are covered as criminal law.

Pharmacopeias

Pharmacopeias

• It is a book containing directions for the identification and preparation of compound medicines.

• recognized officially by the Federal Food, Drug, and Cosmetic Act

• contains descriptions, uses, strengths, and standards of purity for selected drugs and for all of their forms of dosage.

• published by the authority of a government or a medical or pharmaceutical society.

History….

• Although older writings exist which deal with herbal medicine, such as Edwin Smith Papyrus in Egypt, and De Materia Medica a five volume book originally written in Greek are considered the major initial works in the field.

• The latter is considered to be precursor to all modern pharmacopoeias, and is one of the most influential herbal books in history

• A number of early pharmacopoeia books were written by Persian physicians

Pharmacopeias • The first pharmacoepia published under government authority

appears to have been that of Nuremberg in 1542• There are national pharmacopoeias, like the British and

the US pharmacopoeias. All the pharmacopoeias were issued under the authority of government.

• International Pharmacopoeia — Increased facilities for travel have brought into greater prominence the importance of an approach to uniformity in the formulae of the more powerful remedies, in order to avoid danger to patients when a prescription is dispensed in a different country from that in which it was written. Attempts have been made by international pharmaceutical and medical conferences for an international pharmacopoeia to be prepared, but, due to national jealousies and the attempt to include too many preparations in it, this has not succeeded

Pharmacopeias

• Due to modern advancements in pharmacology, pharmacopeias need to be updated and edited frequently.

Questions….