History of the FDC Act
Chris Merriam-Leith
DRUG AND MEDICAL
Jan 20, 2010
History of the FD&C Act of 1938
The Food, Drug and Cosmetic Act (FD&C) of 1938 was the final culmination of a series of legislative actions and tragic events in the United States that spanned a period between the years of 1820 to 1937. The final impetus for the passage of the FD&C act was a direct reactionary result for a series of tragic poisoning incidents that occurred before its enactment, as much as it was in response to a progressive series of ineffectual regulations enacted over time.
Some of the early legislative and pivotal developments that preceded the FD&C act were the following.
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In 1820, the United States Pharmacopoeia (USP) was formed. Initially the USP consisted of a group of pharmacist members whose mission was to create a system of standards, a system of quality control, and a national formulary for drug compounds. At its start only
217 drugs that were able to meet the criteria were initially admitted.1
In 1848, President James K. Polk, signed the Drug Importation Act. This was in direct response for the need for legislation to stem the flood of adulterated products that were being imported into the United States from Europe and other countries. Because this law was exclusively aimed at imported products, a major deficiency of the law was that it did not include any provisions for domestic products.2
This deficiency would eventually require future legislative actions in order to be corrected.
In 1902, the Biologics Control Act was passed. The Biologics Control Act was a result of two separate tragic incidents in which 22 children died as a result of contaminated vaccines. The first incident occurred in St. Louis in 1901 when 13 children died as a result of receiving a contaminated diphtheria antitoxin serum made from the blood of a horse that had contracted tetanus. The second incident occurred shortly after in Camden, N.J. when 9 children died from tetanus after receiving a contaminated
DRUG AND MEDICAL
Jan 20, 2010
History of the FD&C Act of 1938
The Food, Drug and Cosmetic Act (FD&C) of 1938 was the final culmination of a series of legislative actions and tragic events in the United States that spanned a period between the years of 1820 to 1937. The final impetus for the passage of the FD&C act was a direct reactionary result for a series of tragic poisoning incidents that occurred before its enactment, as much as it was in response to a progressive series of ineffectual regulations enacted over time.
Some of the early legislative and pivotal developments that preceded the FD&C act were the following.
•
•
•
In 1820, the United States Pharmacopoeia (USP) was formed. Initially the USP consisted of a group of pharmacist members whose mission was to create a system of standards, a system of quality control, and a national formulary for drug compounds. At its start only
217 drugs that were able to meet the criteria were initially admitted.1
In 1848, President James K. Polk, signed the Drug Importation Act. This was in direct response for the need for legislation to stem the flood of adulterated products that were being imported into the United States from Europe and other countries. Because this law was exclusively aimed at imported products, a major deficiency of the law was that it did not include any provisions for domestic products.2
This deficiency would eventually require future legislative actions in order to be corrected.
In 1902, the Biologics Control Act was passed. The Biologics Control Act was a result of two separate tragic incidents in which 22 children died as a result of contaminated vaccines. The first incident occurred in St. Louis in 1901 when 13 children died as a result of receiving a contaminated diphtheria antitoxin serum made from the blood of a horse that had contracted tetanus. The second incident occurred shortly after in Camden, N.J. when 9 children died from tetanus after receiving a contaminated