Bristol Plymouth Practical Nurse Program Mrs. Janet L. Terra, R.N., C. Section 1 Hour 2

Friends, the ingredients in this bottle will cure all that ails you!

Drug Standards Purity Strength Safety and Toxicity

Federal Food, Drug and Cosmetic Act Set Legal Standards for Drugs United States Pharmacopoeia USP [NF]

Federal Food, Drug and Cosmetic 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 Cosmetic Act – 1938 Tylenol ® acetominophen, USP

Indication of the presence, quantity, and proportion of other drugs Federal Food, Drug and Cosmetic Act – 1938 Active ingredients Inactive ingredients

A warning of habit – forming drugs in the product and their effects Federal Food, Drug and Cosmetic Act – 1938 Warning:

The names of the manufacturer, packager and distributor Federal Food, Drug and Cosmetic 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 Cosmetic 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 Cosmetic Act – 1938 Caution: New Drug – Limited by Federal Law to Investigational Use

Other Important Acts and Laws 1952 Durham – Humphrey Amendment Prescription vs OTC Drugs 1962 Kefauver – Harris Amendment Truth in Advertising

Laws Specific to Narcotics 1914 Harrison Narcotic Act First Narcotic Control Act 1970 Comprehensive Drug Abuse Prevention and Control Act Controlled Substances Act

1970 Controlled Substances Act Double Lock

Shift Narcotic Count 1970 Controlled Substances Act

Time Limits on Prescriptions 1970 Controlled Substances Act 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 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 Nomenclature CH 3 CL N N Chemical Name 8-Chloro-1-methyl-6-phenyl-4H- s-triazolo [4,3-a] [1,4] benzodiazepine Official Name alprazolam, USP Trade (Brand) Name Xanax ®