Pharmacy Law

Front 1

DEA Form 363

Back 1

compound or conduct a narcotic treatment program

Front 2

DEA Form 41

Back 2

disposal or destruction

Front 3

DEA Form 224

Back 3

dispense (pharmacies)

Front 4

DEA Form 106

Back 4

theft

Front 5

DEA Form 222

Back 5

to order CII substances

Front 6

DEA Form 225

Back 6

manufacturer or distribute

Front 7

Pure Food and Drug Act

Back 7

First pharmacy law; prohibits manufacture, sale, or transport of poisonous patent medicines

Front 8

Harrison Narcotic Act

Back 8

requires prescriptions for opium- based products (narcotics)

Front 9

Food, Drug, and Cosmetic Act (FDCA)

Back 9

all drugs are required to have directions for use and warnings

Front 10

Labeling requirement for prescription labels

Back 10

pharmacy name, address, phone number
serial number (Rx number)
date of fill
expiration date
patient's name
prescriber's name
directions for use
warnings (if needed)
auxiliary labels (if needed)

Front 11

Durham- Humphrey Amendment

Back 11

made the distinction between legend drugs and OTC drugs; later replaced legend with "Rx only"

Front 12

Kefauver- Harris Amendment

Back 12

required drugs to be safe and effective

Front 13

Comprehensive Drug Abuse Prevention and Control Act

Back 13

established the DEA; created the five schedules of controlled substances

Front 14

Poison Prevention Packaging Act

Back 14

all prescription drugs must be dispensed in childproof containers

Front 15

Drug Listing Act

Back 15

National Drug Code (NDC) xxxxx-xxxx-xx
1st set- manufacturer
2nd set- drug name, strength, dosage form
3rd set- package size

Front 16

Medical Device Amendment

Back 16

Requires the safety and effectiveness of life- sustaining and life- supporting devices

Front 17

Orphan Drug Act

Back 17

created to stimulate the development of drugs for rare diseases (200,000 people or less)
Incentives:
seven- year market exclusivity
tax credit of 50% cost of conducting human trials
federal research grants for testing treatments
waiver of new drug application FDA fees

Front 18

Drug Price Competition and Patent Term Restoration Act

Back 18

aka Hatch- Waxman Act
allows patent extension on trade name
once patent expires, allows faster approval process for generic version

Front 19

Prescription Drug Marketing Act

Back 19

created to address diversion of large quantities of drugs into a secondary "gray" market

Front 20

Anabolic Steroids Control Act

Back 20

placed anabolic steroids on schedule CIII

Front 21

OBRA '90

Back 21

Omnibus Budget Reconciliation Act
mandates the pharmacists to perform a drug utilization review (DUR) and off counseling to patients

Front 22

PDUFA

Back 22

Prescription Drug User Fee Act
authorizes FDA to collect fees from companies that produce certain human drug and biological products

Front 23

Dietary Supplement Healthy and Education Act

Back 23

greater regulation on dietary supplements
label: "These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

Front 24

HIPAA

Back 24

Health Insurance Portability and Accountability Act
protects health information

Front 25

Medicare Prescription Drug, Improvement, and Modernization

Back 25

created prescription drug plan for Medicare patients called Medicare Part D
Medicare patients include elderly, disabled, renal (kidney) failure patients
requires pharmacist to off medication therapy management (MTM) which is in depth counseling on all of the patient's medications

Front 26

Food and Drug Administration Modernization Act

Back 26

legend drugs must read "Rx only"
adjustment to Durham- Humphrey Amendment

Front 27

Combat Methamphetamine Epidemic Act

Back 27

regulates sale of ephedrine, pseudoephedrine, phenylpropanolamine products
daily sale limit to 3.6 grams a day
monthly sale limit to 9 grams a month