D398 Introduction to Pharmacology ALL ABOUT OA Study Guide 2026-2027 NEW
VERSION UPDATE Western Governors University
ntroduction to Pharmacology - D3G8 Section One – Medication Safety
Lesson One: Consumer Safety s Drug Regulation
Drug standards are regulations that drug manufacturers must follow to ensure safety and
protect consumers. Key legislation includes:
• 1906 Pure Food and Drug Act: Established standards for strength, purity, and
quality; required labeling of dangerous ingredients.
• 1938 Federal Food, Drug, and Cosmetic Act: Created the FDA; enforced labeling,
drug approval, and warning labels.
• 1970 Controlled Substances Act: Established the DEA; set standards for abused
drugs and required prescriber registration.
Drug Laws
Throughout history, people have used substances and drugs for healing. With scientific
advances, consumer safety has become crucial. During the 1900s, laws were enacted to
ensure the safe dispensing of drugs in the U.S.
Drug standards assure consumers receive drugs of uniform strength, quality, and purity.
This standardization ensures prescriptions are consistent, regardless of pharmacy or
location. Companies must meet federally approved requirements for drug strength, quality,
and purity, without adding other active ingredients or varying chemical amounts.
The lack of enforcement in the illegal drug market poses dangers, leading to overdoses and
deaths. The evolution of consumer safety laws can be seen in three key acts:
• 1906 Pure Food and Drug Act: Established standards for strength, purity, and
quality.
• 1938 Federal Food, Drug, and Cosmetic Act: Created the FDA; mandated drug
safety testing after a 1937 disaster.
, • 1970 Controlled Substances Act: Established the DEA; set standards for abused
drugs.
1S0c Pure Food and Drug Act
The first government attempt to protect consumers in drug and food manufacture required
all U.S. drugs to meet minimal standards of strength, purity, and quality. Drug preparations
containing dangerous ingredients had to be labeled, with 11 initially identified, such as
morphine. The legislation also established two official drug references: the United States
,Pharmacopeia (USP) and the National Formulary (NF). These have since been combined
into one book, the USP/NF.
1S38 Federal Food, Drug, and Cosmetic Act and Amendments of 1S51, 1Sc2, and 1S72
Established the Food and Drug Administration (FDA) under the Department of Health and
Human Services to enforce the provisions of the act.
Established more specific regulations to prevent adulteration of (tampering with) drugs,
foods, and cosmetics:
All labels must be accurate and must include a listing of all active and inactive ingredients.
Figure 1-1 shows an example of required product information for an over-the-counter (OTC)
medication (no prescription [Rx] needed).
All new products must be FDA-approved before public release. Certain preparations
require warning labels (e.g., "may cause drowsiness," "may be habit-forming"). Legend
drugs must be labeled with “Caution—federal law prohibits dispensing without a
prescription.” Both prescription and nonprescription drugs must be effective and safe.
In 1972, the National Drug Code (NDC) Directory was created, listing all commercially
distributed drugs. Each drug has a unique NDC number with three parts:
, • Manufacturer (5 digits)
• Drug (4 digits)
• Package size (2 digits)
Example: 00406-0123-01 (or 0406-123-01).
Controlled substances are categorized into five schedules, from Schedule I (highest abuse
potential) to Schedule V (least abuse potential), with lower numbers having stricter DEA
control. Schedule I drugs are illegal and not approved for medical use in the U.S.
Drugs can be moved between schedules based on societal issues, such as increased
overdoses. Health care professionals must stay informed of changes in drug scheduling,
typically found in the latest drug reference books.
Controlled substances are identified by a "C" followed by a Roman numeral (I-V) indicating
their schedule. Labels and drug inserts also display this designation.
1S70 Controlled Substances Act
The Drug Enforcement Administration (DEA), established under the Department of Justice,
enforces drug regulations. It controls specific abused substances, such as depressants,
stimulants, psychedelics, narcotics, and anabolic steroids, categorizing them into five
schedules (C-I to C-V) based on medical value, harmfulness, and potential for abuse. The
act requires strict security and accountability, with special DEA forms for inventory and
transactions. Prescription guidelines regulate the number of times drugs can be prescribed
within six months and which schedules can be phoned into pharmacies. All prescribers,
including pharmacists and drug manufacturers, must register with the DEA and obtain a
registration number.
Clinical Application
VERSION UPDATE Western Governors University
ntroduction to Pharmacology - D3G8 Section One – Medication Safety
Lesson One: Consumer Safety s Drug Regulation
Drug standards are regulations that drug manufacturers must follow to ensure safety and
protect consumers. Key legislation includes:
• 1906 Pure Food and Drug Act: Established standards for strength, purity, and
quality; required labeling of dangerous ingredients.
• 1938 Federal Food, Drug, and Cosmetic Act: Created the FDA; enforced labeling,
drug approval, and warning labels.
• 1970 Controlled Substances Act: Established the DEA; set standards for abused
drugs and required prescriber registration.
Drug Laws
Throughout history, people have used substances and drugs for healing. With scientific
advances, consumer safety has become crucial. During the 1900s, laws were enacted to
ensure the safe dispensing of drugs in the U.S.
Drug standards assure consumers receive drugs of uniform strength, quality, and purity.
This standardization ensures prescriptions are consistent, regardless of pharmacy or
location. Companies must meet federally approved requirements for drug strength, quality,
and purity, without adding other active ingredients or varying chemical amounts.
The lack of enforcement in the illegal drug market poses dangers, leading to overdoses and
deaths. The evolution of consumer safety laws can be seen in three key acts:
• 1906 Pure Food and Drug Act: Established standards for strength, purity, and
quality.
• 1938 Federal Food, Drug, and Cosmetic Act: Created the FDA; mandated drug
safety testing after a 1937 disaster.
, • 1970 Controlled Substances Act: Established the DEA; set standards for abused
drugs.
1S0c Pure Food and Drug Act
The first government attempt to protect consumers in drug and food manufacture required
all U.S. drugs to meet minimal standards of strength, purity, and quality. Drug preparations
containing dangerous ingredients had to be labeled, with 11 initially identified, such as
morphine. The legislation also established two official drug references: the United States
,Pharmacopeia (USP) and the National Formulary (NF). These have since been combined
into one book, the USP/NF.
1S38 Federal Food, Drug, and Cosmetic Act and Amendments of 1S51, 1Sc2, and 1S72
Established the Food and Drug Administration (FDA) under the Department of Health and
Human Services to enforce the provisions of the act.
Established more specific regulations to prevent adulteration of (tampering with) drugs,
foods, and cosmetics:
All labels must be accurate and must include a listing of all active and inactive ingredients.
Figure 1-1 shows an example of required product information for an over-the-counter (OTC)
medication (no prescription [Rx] needed).
All new products must be FDA-approved before public release. Certain preparations
require warning labels (e.g., "may cause drowsiness," "may be habit-forming"). Legend
drugs must be labeled with “Caution—federal law prohibits dispensing without a
prescription.” Both prescription and nonprescription drugs must be effective and safe.
In 1972, the National Drug Code (NDC) Directory was created, listing all commercially
distributed drugs. Each drug has a unique NDC number with three parts:
, • Manufacturer (5 digits)
• Drug (4 digits)
• Package size (2 digits)
Example: 00406-0123-01 (or 0406-123-01).
Controlled substances are categorized into five schedules, from Schedule I (highest abuse
potential) to Schedule V (least abuse potential), with lower numbers having stricter DEA
control. Schedule I drugs are illegal and not approved for medical use in the U.S.
Drugs can be moved between schedules based on societal issues, such as increased
overdoses. Health care professionals must stay informed of changes in drug scheduling,
typically found in the latest drug reference books.
Controlled substances are identified by a "C" followed by a Roman numeral (I-V) indicating
their schedule. Labels and drug inserts also display this designation.
1S70 Controlled Substances Act
The Drug Enforcement Administration (DEA), established under the Department of Justice,
enforces drug regulations. It controls specific abused substances, such as depressants,
stimulants, psychedelics, narcotics, and anabolic steroids, categorizing them into five
schedules (C-I to C-V) based on medical value, harmfulness, and potential for abuse. The
act requires strict security and accountability, with special DEA forms for inventory and
transactions. Prescription guidelines regulate the number of times drugs can be prescribed
within six months and which schedules can be phoned into pharmacies. All prescribers,
including pharmacists and drug manufacturers, must register with the DEA and obtain a
registration number.
Clinical Application
