• Adulturation
• Misbranding
• Can't place into interstate commerce unproved drugs 

• Cover Cosmetics too
• New Drug Application (NDA)
• Created FDA
• First to ensure Rx is Safe before distribution

• Rx vs. OTC
• Labeling
• How Rx drugs must be Dispensed

• Safe and Effective
• Good manufacturing Practices

• Wholesale standards for storage/handeling
• Samples

Controlled Substance Ordering System 

(CSOS)

222 form Copy 1

• Color
• Who?

• Brown
• Supplier 

222 form Copy 2

• Color
• Who?

• Green
• DEA

222 form Copy 3

• Color
• Who?

• Blue
• Receiver

Investigational New Drug

(IND)

• How quickly does DEA make decision?

• Before can be tested in humans
• Drugs not marketed in US
• DEA makes decision within 30 days

• Testing for safety
• Kinetics
• Adverse effects

• Assessing for efficacy of a drug

• More comprehensive test of benefits vs risk of a drug

• Post marketing surveillance of a drug 

Supplemental New Drug Application

(SNDA)

• Changing the location or process of manufacturing
• drug synthesis
• packaging

Abbreviated New Drug Application

(ANDA)

• Generic

Controlled Substance Registration Protection Act

(CSRPA)

• costs >500$ to replace theft
• Employee suffers significant injury/death
• Interstate/Foreign commerce involved

• Drugs that treat serious conditions
• Unmet medical needs

"The NEW FAST and furious movie."

• Substantial improvement over available therapy

• Drugs with long-term hard to measure endpoints

Safe Medical Device Act

(SMDA)

• First to require facilities to report death from medical devices to manufactures.

loss of controlled substance

• Poison prevention packaging act

• Can't be sold to other pharmacy/TP
• can't be >5% RX sold 

• NDC (Drug registration)

• Consumer Product Safety Commission (CPSC)

CSA

• Created DEA

• Are people taking too much?
• Are people stealing it?
• Do people want it without Doctor's advice?
• Similar to another CS?

Codeine 

• CIII
• CV

• <90mg/dose solid
• <200mg/100ml liquid 

• Destruction of controlled substance

• Distributer

• Patient
• Drug
• Dr. Signature

• Enabled manufacturers to discuss off label use
• Expedited clinical trials 

Drug Quality Security Act (DQSA)

• 503A
• 503B

• patient, prescriber,pharmacist compounding
• Facilities that compound in bulk

• FTC

• FDA

• sterile compounds W/O PT Rx. 

• US attorney general 

• FDA

• Pharmacy register with DEA