all legend and controlled drugs, with some exception, must be dispensed in a childproof container.

Studies indicate no risk to human fetus

- contains the proprietary name
- qualitative and or quantitative ingredient information

Heroin

Who is automatically set-up for Medicare?

To Establish standards for workplace health and safety.

Studies show no risk to animal fetus; information for humans not available

Every side effect that has been reported

LSD

__________ receive a 5% higher allowance from Medicare

Created a distinction between "OTC" and "Legend Drugs".

fetal abnormalities reported and positive evidence of fetal ris in humans available from animal and human studies. Not to be used in pregnant women

The labeling must describe clinically significant adverse reactions and other potential safety hazards, including those resulting from drug/drug interactions; limitations in use imposed by them; and steps that should be taken if they occur

Benzphetamine

Medicare insurnance is for people over age 65, younger people with _________ and people with End Stage Renal Disease

Required that "Secret Elixirs" containing ingredients like: Cocaine, Heroin, Morphine and Alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages.

Category C Adverse effects reported in animal fetus; information for humans not available.

This section of the labeling must describe situations in which the drug should not be used because the risk of use clearly outweighs any possible therapeutic benefit

Diazepam

In 2006 Medicare part D was added to provide optional coverage for _______________

Also known as the "Drug Efficacy Amendment".

Possible fetal risk in humans reported; however, consideration of potential benefit vs. risk may, in selected cases warrant the use of these drugs in pregnant women.

Should be a concise summary of information concerning the product's dosage forms

Opium

Part what provides hospital insurance?