Transcript PURE FOOD AND DRUG ACT (1906)

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
drugs
1. 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