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What's on a MONOGRAPH?
Description, Clinical Pharmacology, Indications and Usage, Contraindications, Warnings, Precautions, Drug Abuse and Dependence, Adverse Reactions, Dosage, and How Supplied
What form do pharmacies fill out to order prescriptions?
Form 224 is needed by the pharmacy to dispense controlled substances
Form 225 is to manufacture or distribute controlled substances
CLASS IV substances
1. Make sure the first letter is A, B or M
2. 2nd letter must be 1st letter of prescriber's last name
3. Add 1st, 3rd and 5th number
4. Add 2nd, 4th, and 6th number
5. Add 2 sums together
6. Last digit from total should be last digit of DEA set
Any medication taken from bulk packages and placed into blister packs must have the following information:
1. Drug name (trade/generic)
3. Dosage form
5. Lot number
6. Expiration date
Food, Drug and Cosmetic Act
Required drug companies to include directions for use for the consumer in package inserts on drugs; required the marking WARNING: MAY BE HABIT FORMING for all narcotics
Attempted to ensure the safety and effectiveness of all new drugs introduced to the market
Prescription Drug Marketing Act
Required the label CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN for certain drugs
Omnibus Budget Reconciliation Act
States that a pharmacist must counsel all patients who receive new prescriptions at the time of purchase
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