The profession of pharmacy, medications, medical devices, and other related entities are all controlled by laws which must be adhered to in order to ensure the protection and safety of the general public. Laws passed by federal and state lawmakers on pharmacy-related matters may provide detailed requirements, but also authorize specific agencies to interpret, apply, and enforce the law(s). To accomplish this, agencies develop regulations, rules, and guidelines that are generally much more detailed and specific. Whereas laws are difficult to change because of the barriers of the legislative process, regulations and rules can be added, modified, or removed with more ease. Everyone involved in activities relevant to the practice of pharmacy has the responsibility to be aware of and adhere to all applicable laws, regulations, and rules. To understand and be compliant with regulatory requirements, it is important to first understand exactly what a law and a regulation are, where they come from, and what role they play in governing the profession.