Resources, Agencies, Boards Flashcards
Where are Statutes and Regualtions found?
Federal Statues -> US Code
Regulations -> (Code) of Federal Regulations
Both are codes
Who puts out the Regulations
Administrative agencies
Who makes the Federal statutes (in US code)?
Legislation -> Congress
Who makes Regulations?
Administrative agencies
-> DEA, FDA, The Federal Trade Commission (FTC), and more
Statutes and Regulations
Federal and State level
Federal:
Statutes -> US Code
Regulations: Code of Federal Regulation
State Level:
Statutes -> TN Code (TCA)
Regulations (Rules) -> Board of Pharmacy Rules
Remember: the administrative agencies make Regulations - the Board of Pharmacy is one of these administrative agencies
What is the responsibility of the FDA?
Protecting the public health
-> safety, efficacy, security of human and veterinarian drugs, foods, cosmetics…
-> Regulating tobacco products
What are the responsibilities of the DEA?
-enforces controlled substances laws and regulations
-working on reducing the availability of illicit controlled substances on the domestic and international markets
To which department does the DEA belong?
Department of Justice
Responsibilities of Centers for Medicare and Medicaid Services (CMS)
-advocating for the recognition of pharmacists as a provider
-brought in the Part D program (insurance)
-big payer
To which department does the CMS belong?
Department of Health and Human Services (HHS)
Federal Trade Comission (FTC)
-regulates how you conduct the business of your own pharmacy - prevents unfair methods of competition
-regulates OTC product advertising
(FDA regulates Rx advertising)
TN Board of Pharmacy
given power by the TN Pharmacy Practice Act (in the TN Code, TCA)
What type of professionals make up the Board of Pharmacists?
7 pharmacists
1 tech
1 non-pharmacist consumer
Tennessee Pharmacist Association (TPA)
-represent the profession of pharmacy
-they develop standards of practice
-more of an advocacy group rather than having a regulatory function -> but they are still influential
