Bristol PlymouthPractical Nurse Program

Mrs. Janet L. Terra, R.N., C.

Section 1Section 1

Hour 2

Friends, the ingredients

in this bottle will

cure all that ails you!

Drug StandardsDrug Standards

Purity

Strength

Safety and Toxicity

1906 - Federal Food, Drug and 1906 - Federal Food, Drug and Cosmetic ActCosmetic Act

Set Legal Standards for Drugs

United States Pharmacopoeia

USP [NF]

Federal Food, Drug and Federal Food, Drug and Cosmetic Act – 1938Cosmetic Act – 1938

• A statement accurately describing the package’s contents

Each tablet contains acetominopen 325 mg.

• The usual names of the drug(s), both official and non – official

Federal Food, Drug and Federal Food, Drug and Cosmetic Act – 1938Cosmetic Act – 1938

Tylenol ®

acetominophen, USP

• Indication of the presence, quantity, and proportion of other drugs

Federal Food, Drug and Federal Food, Drug and Cosmetic Act – 1938Cosmetic Act – 1938

Active ingredients

Inactive ingredients

• A warning of habit – forming drugs in the product and their effects

Federal Food, Drug and Federal Food, Drug and Cosmetic Act – 1938Cosmetic Act – 1938

Warning:

• The names of the manufacturer, packager and distributor

Federal Food, Drug and Federal Food, Drug and Cosmetic Act – 1938Cosmetic Act – 1938

Distributed by

McNeil Consumer Healthcare

Fort Washington, PA

• Directions for use and warnings against unsafe use, including recommendations for dosage levels and frequency

Federal Food, Drug and Federal Food, Drug and Cosmetic Act – 1938Cosmetic Act – 1938

Recommended dose

Not to exceed 8 tablets in 24 hours, or as directed by a doctor

• A statement on all new drugs not yet approved for interstate commerce

Federal Food, Drug and Federal Food, Drug and Cosmetic Act – 1938Cosmetic Act – 1938

Caution: New Drug – Limited by Federal Law to Investigational Use

Other Important Acts and Other Important Acts and LawsLaws

1952 Durham – Humphrey AmendmentPrescription vs OTC Drugs

1962 Kefauver – Harris AmendmentTruth in Advertising

Laws Specific to NarcoticsLaws Specific to Narcotics

1914 Harrison Narcotic ActFirst Narcotic Control Act

1970 Comprehensive Drug AbusePrevention and Control Act

Controlled Substances Act

1970 Controlled Substances 1970 Controlled Substances ActAct

• Double Lock

• Shift Narcotic Count

1970 Controlled Substances 1970 Controlled Substances ActAct

1

2

3

6

5

4

• Time Limits on Prescriptions

1970 Controlled Substances 1970 Controlled Substances ActAct

6/23/02 Meperidine 50 mg po q4h prn back pain

Les Lurnett, MD

6/26/02 Renew Meperidine 50 mg po q4h prn back pain

Les Lurnett, MD

Drug NomenclatureDrug Nomenclature

Xanax used to alleviate anxiety

Zantac used to prevent ulcers

Zocor cholesterol lowering agent

Zoloft anti - depressant

Drugs may have similar names

Don’t be confused

Drug NomenclatureDrug Nomenclature

CH3

CL N

N

Chemical Name8-Chloro-1-methyl-6-phenyl-4H-

s-triazolo [4,3-a] [1,4] benzodiazepine

Official Namealprazolam, USP

Trade (Brand) NameXanax ®