Generally, regulations are made by unelected officials from a government agency and are called regulations or administrative rules. The agency gets its power to make regulations and rules from the federal or state legislature which specifically delegates power to that agency to make rules about specific topics. The delegation of power is an important concept in our history and was initially very controversial because we did not want unelected officials to be making laws. So, there were guidelines put in place for rulemaking requiring the agency to have public comment and ability to appeal rules.  Because regulations are often monitored and enforced by the agency that made the regulations, they are adjudicated, not by the agency itself, but by what is called an Administrative Law Judge within the Administrative Court system. These contested administrative law cases have rules about how the cases can be referred to the regular court systems if needing appeal. Regulations and rules can be challenged and may not carry the same weight as laws but can be enforced like laws.

Constitution: “the law of the land.”

The U.S. Constitution is a law agreed upon by the founders of our country. And it can only be amended by going through the process that they set forth in the Constitution for amendments.

Federal, State, and Municipal laws

Congress passes laws that set the stage for the future nationwide. For example, it defines what is considered to be a “drug” and what is required for it to go to market. It also passes laws delegating authority of agencies to do specific tasks, for example when it passed the National Childhood Vaccine Injury Act of 1986 – which amended the Public Health Service Act to establish in the Department of Health and Human Services a National Vaccine Program. States pass similar laws that apply to those within their state, for example states define “the practice of medicine” within the state and who can practice the healing arts. And states also pass laws delegating authority to state agencies to do specific tasks, such as emergency management within the state. When a law that is passed by elected officials is challenged, sometimes it is challenged in court and the court’s interpretation of those laws ends up being what is called “case law.”

Federal and State regulations

Since the making of regulations or administrative rules requires a public process, the federal government posts all the public notices in the Federal Register. The states publish their notices in their State Register. Reading these registers provides a deep insight into the workings of agency activities.