FDA http://www.fda.gov/Drugs/default.htm Began with the passage of the 1906 Pure Food and Drugs Act Prohibited misbranded and adulterated food and drugs in interstate commerce FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), and veterinary products.

FDA New drug approval * After reviewing all documentation on the safety and effectiveness of the new drug *May be protected by a patent for up to 17 years

DEA Drug Enforcement Agency The Controlled Substances Act of 1970 regulates the manufacturing, distribution, and dispensing of drugs that are known to have abuse potential. DEA is responsible for the enforcement of these regulations. The controlled drugs are divided into five DEA schedules based on their potential for abuse and physical and psychological dependence.

Ex: heroin, marijuana, LSD Schedule I High abuse potential and no accepted medical use Ex: heroin, marijuana, LSD

High abuse potential with severe dependence liability Schedule II High abuse potential with severe dependence liability Ex: narcotics, amphetamines, and barbiturates

Schedule III Less abuse potential than schedule II drugs and moderate dependence liability Ex: nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics

Ex: some sedatives, antianxiety agents, and non-narcotic analgesics Schedule IV Less abuse potential than schedule III and limited dependence liability Ex: some sedatives, antianxiety agents, and non-narcotic analgesics

Schedule V Limited abuse potential. Primarily small amounts of narcotics (codeine) used as antitussives or antidiarrheals. Under federal law, limited quantities of certain schedule V drugs may be purchased without a prescription directly from a pharmacist

DEA Monitoring Prescribing physicians and dispensing pharmacists must be registered with the DEA DEA # provides forms for the transfer of Schedule I and II substances and establishes criteria for the inventory and prescribing of controlled substances.

FDA Pregnancy Categories A-X The FDA has established five categories to indicate the potential of a drug to cause birth defects if used during pregnancy. The categories are determined by the reliability of documentation and the risk to benefit ratio. **They do not take into account any risks from pharmaceutical agents or their metabolites in breast milk**

Category A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Ex: folic acid, vitamin B6, and some thyroid medicines in prescribed doses.

Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. EX: antibiotics, acetaminophen (Tylenol), aspartame (artificial sweetener), famotidine (Pepcid), prednisone (cortisone), insulin (for diabetes),

Category C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Ex: Prozac, Zoloft (antidepressants); Tamiflu (antiviral

Category D There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. EX: tetracycline (antibiotic); Cytoxan (chemotherapy

Category X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. EX: Accutane, thalidomide, vitamin A congeners, Xanax