Chapter One

Drug Standards- rules set to assure consumers that they get what they pay for; all preparations called by the same drug name must be of uniform strength, quality, and purity

PURE FOOD AND DRUG ACT (1906)• First gov’t attempt to establish consumer protection• Required all drugs in the U.S. to meet minimal standards• Demanded that anything containing morphine must be

labeled as such• Established 2 written references of officially approved

drugs1. United States Pharmacopoeia (USP)

2. National Formulary (NF)• These references have since combined into one book

(USP/NF)

FEDERAL FOOD, DRUG, AND COSMETIC ACT (1938) and AMENDMENTS (1951, 1965)

• Established the Food and Drug Administration (FDA) to enforce provisions

• All labels must be accurate and include generic names

• All new products must be approved by the FDA • Certain medications must contain warning

labels, ex. “may cause drowsiness”• Certain drugs must be labeled with a legend

(cannot dispense without prescription) – “legend drugs”; also designated which drugs may be sold without prescriptions

• Prescription and nonprescription drugs must be shown to be effective as well as safe

CONTROLLED SUBSTANCES ACT (1970)• Established the Drug Enforcement Administration (DEA) as part of

the Department of Justice • Established tighter control of drugs that were being abused by

society• Isolated the addicting drugs into five levels (schedules) according to

their degree of danger• Demanded security of controlled substances (anyone who handles

controlled substances must keep on hand DEA forms indicating exact current inventory and two-year inventory of every transaction

• Set limitations on the use of prescriptions; guidelines were established for each of the five schedules, regulating the number of times they may be prescribed in a 6 month period and which substances may be phoned, etc.

• Demanded that each prescriber register with the DEA and obtain a number that must be present on prescriptions

• Drug manufacturers, pharmacists, physicians, veterinarians, dentists, etc. must all be registered with the DEA

Schedule of Controlled Substances – p. 7

Differences in FDA and DEA – p. 9

Healthcare Workers and the Law – p. 10