Federal Drug Laws

Front 1

CMS

Back 1

Center for Medicare and Medicaid Services - Agency established to coordinate medicare and medicaid benefits

Front 2

food, Drug, and cosmetic act

Back 2

new drugs must be proven safe before marketing; law gave more power to FDA

Front 3

Durham-Humphery Amendment.

Back 3

Defines what drugs need a prescription and which are OTC; requires them to need a legend label

Front 4

Kefauver-Harris Amendment.

Back 4

Manufactures have to prove that a drug is safe AND EFFECTIVE before marketing (pregnant women- baby defects)

Front 5

Poison Prevention Packaging Act.

Back 5

Requries childproof packaging on all controlled substances and most prescription drugs

Front 6

Controlled SUbstances Act.

Back 6

Classifed the five levels of controlled substances based on their potnetial for abuse; restricts distribution; and established the DEA to enforce regulations

Front 7

Orphan Drug Act

Back 7

Provides finacial insentives to drug companies to research and market drugs for orphan diseases

Front 8

Omnibus Budget Reconciliation Act (OBRA)

Back 8

Requries pharmasicits to offer counseling to Medicaid patients regarding medications

Front 9

Anabolic Steroid Control Act

Back 9

Classified anabolic steroids as a Schedule III controlled substance that requires a prescription

Front 10

Health Insurance Portability and Acountability Act

Back 10

Protects the health information of patients and established types of PHI that must not be shared without patient consent

Front 11

Combat Methanphetamine Epidemic Act

Back 11

Set dailt and monthly restrictions on the amount of ephedrine or pseudoephedrine that can be sold to an individual meth does not require a precription, but must be kept behind the counter (3.6 grams daily)

Front 12

Drug Listing Act

Back 12

requires manufacutres to send a list of all of their drug products to the FDA > establishes NDC for each product

Front 13

1st set.

Back 13

Manufacturer

Front 14

2nd set.

Back 14

drug and strenth

Front 15

3rd set.

Back 15

package size

Front 16

Drug Supply Chain Security Act

Back 16

sets up system for electronic tracking of prescription drug distribution and requires notifiying the FDA of counterfiet or contaminated products

Front 17

Medicare Modernization Act

Back 17

Created a drug benefit program for medicare recipients (Medicare D)