Pharmacy Law

Front 1

1938 death elixir

Back 1

created the FDA

Front 2

1962 Kefauver Committee Amendment

Back 2

Requires drugs to be safe and package inserts

Front 3

1988 Drug Marketing Act

Back 3

established procedures between pharmacies, manufactures & wholesalers

Front 4

Those who who may prescribe medication are referred to as:

Back 4

prescribers or practitioners

Front 5

Under certain circumstances OTC drugs must be treated as prescription medications:

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if script calls for a higher doses than recommended
if used for non approved OTC uses
if script specifies refills for OTC
if OTC prescribed is CV

Front 6

Labeling & misbranding
medication must be kept in original containers to be legal

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keep out of reach of children label is required on all salicylate preparations

Front 7

Federal law prescription label

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name & add of pharmacy, patient name, prescriber name, drug, directions, date script filled, RX#, GA law requires phone # of pharmacy and expiration date

Front 8

National Drug code - NDC#

Back 8

1st 4-5 numbers - manufactures assigned by the FDA, 2nd # drug name & strength, package size

Front 9

Poison Prevention Center - 1970
Consumer product safety act - 1972

Back 9

required pharmacist to use child resistant lids
nitroglycerine & sublingual are exempt

Front 10

Prescriptions must be kept on file for

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2 years after they are filled, computer generated reports are acceptable

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Syringes

Back 11

must be kept in pharamacy

Front 12

Hospital regs when pharmacist not available

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a nurse or physician may be given access

Front 13

Schedule II in hospitals

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perpetual inventory is required

Front 14

investigational drugs

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information must be kept in a central location & returned to original sources if discontinued

Front 15

Emergency kits in hospitals

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must be inventoried every 30 days

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schedule I drugs are:

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marijuana, LSD, cocaine no currently accepted medical use

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schedule II drugs

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high potential of abuse must have new script each time

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schedule III, IV, V drugs

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are as not addictive as cII, can be filled 5 times in 6 months if authorized

Front 19

schedule drug labels

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must in a transfer warning - Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed

Front 20

Pharmacy inventory

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must be taken every two years on odd numbered years on May 1st, must be indicated if taken at the end or beginning of the day

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Partical filling of CII can only be done under the following conditions:

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Remaider can be filled within 72 hrs or a terminally ill patient

Front 22

Schedule III, IV, V transfer between pharmacies can only be done

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1 time

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Class I drug recall

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will cause the most serious, adverse effects or death - must contact patient

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Class II drug recall

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product may cause temporary or medically reversible adverse health affects (mix up in strength, etc)

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Class III recall

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product will not likely cause adverse affects, (wrong container, etc)

Front 26

Drug recall initated by FDA or manufacturer

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look at 2nd set of numbers & lot numbers