Final answer:
Non-compliance with REMS requirements by pharmacists or pharmacies is considered a regulatory violation with potentially serious consequences, including fines and suspension of medication approval.
Step-by-step explanation:
If a pharmacist or pharmacy fails to comply with REMS requirements, it is considered non-compliance, a regulatory violation that can have severe consequences. REMS, or Risk Evaluation and Mitigation Strategies, are a set of measures that the Food and Drug Administration (FDA) requires pharmaceutical companies to implement in order to ensure that the benefits of a medication outweigh its risks. Non-compliance with REMS requirements can result in significant penalties including fines, legal actions, or even suspension of the medication's approval, thus impacting the pharmacy's operations and its ability to continue dispensing certain medications.