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6. Estrogen
7. Intrauterine device
OBRA ACT OF 1990
It is known as the Omnibus Budget Reconciliation Act of 1990. It requires that pharmacists must offer counseling
to a patient.
THE FDA EMPLOYS A TWO LETTER CODING SYSTEM FOR THERAPEUTIC EQUIVALENCE OF DIFFERENT DRUGS
AA: Drugs that are available in conventional dosage forms and have no bioequivalence problems.
AT: Topical drugs that meet bioequivalence standards.
AB: Drugs meeting the necessary bioequivalence requirements.
BC: Drugs in extended release dosage form with bioequivalence issues.
BT: Topical drugs with bioequivalence issues.
BX: Drugs for which adequate information is not available to determine their bioequivalency.
POISON PREVENTION ACT
This law was implemented to prevent the death of children from accidental poisoning. This act was passed in
1973. It indicates that all dispensed drugs must be dispensed in a child proof or a child resistant container.
Drugs exempt from this law are:
1. Sublingual dosage form of nitroglycerine
2. Sublingual and chewable form of Isosorbide dinitrate (less than 10mg)
3. Cholestyramine powder
4. Methylprednisolone tablets (less than 84 mg)
5. Mebendazole tablets (less than 600 mg of drug)
6. Potassium supplements (unit dose form)
7. Erythromycin ethyl succinate (liquid and granules not more than 8 gm of drug)
8. Colestipol in powder form
9. Erythromycin ethyl succinate (tablets no more than 16 gm of drug)
10. Pancrelipase preparations
11. Prednisone (tablets no more than 105 mg)
12. Oral contraceptives
CONTROLLED SUBSTANCE ACT
CSA = Controlled Substance Act
DEA = Drug Enforcement Administration
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