Law Week 4

Prescription drug monitoring programs, standards for compounding and handling hazardous medications, managing technician responsibilities, and prescribing options as a pharmacist (restrictions)

More OTC products/ OTC birth control , covid kits
Increased prescribing rights for PA or PharmD

three branches of government.
Executive, Legislative and Judicial
pharmacy one of the most regulated professions

federal law will
preempt state law under the Supremacy Clause of the U.S.
Constitution.

less strict

interstate commerce clause

10th amendment

health, safety, and wellness/ authority of the agency

U.S. congress (house and senate ) must agree on an identical bill
President signs the bill or vetos it/pocket veto
These laws are then interpreted by administrative agencies

A federal or state government agency created by the legislature to perform a specific function, such as to make and enforce rules pertaining to the environment.
FDA/ DEA
enforce laws that congress wants but is in the scope of the executive branch and reports to the president

Promote and make known the regulations that must be followed
New regulations involve notice and comment period
Regulations are only valid if it is within the scope of the agency's authority, based on statutory authority, and for the public health safety/welfare
Post regulations on FEDERAL REGISTER and can involve new rulemaking, ones in proposition process, goals of proposed/passed regulations, changes to existing rules, etc.

Hold "hearings" similar to court proceedings to enforce laws/regulations
Subject to judicial review if result is unfair or not enough evidence and only after exhausting all remedies

1 The proposed regulations outlining the change
2. A notice of intent to enact this regulation
3. FDA reasons for proposing the regulation
4. A number would be included that would indicate where in the CFR it would be located if enacted
5. The notice would invite public comment by a certain date
6. At the end of the comment period, the FDA would review the comments and draft final regulations
7. The final regulations, agency's comments and effective date in the Federal Register

Common law - called judge-made law because it originates in the courts.
Statutory law - developed by the legislative branch of the state and the US Congress of the federal government.
merge when courts are required to interpret meaning of statutes

Legislature: writes laws and creates agencies
Administrative Agencies: creates and enforces regulations
Courts: use laws and regulations to determine liability in court