2
Pharmacy Law,
Regulations, and
Standards
Learning Objectives
1 Outline an overview of governmental pharmacy oversight in the US. (Section 2.1)
2 Define the terms laws, regulations, standards, and professional ethics. (Section 2.2)
3 Summarize how drug injuries and deaths lead to protective legislation. Describe significant federal drug laws in the 20th century and their effects on pharmacy practice in the United States. (Section 2.3)
4 Outline the different roles of government regulatory agencies and professional organizations—such as the Food and Drug Administration, Drug Enforcement Administration, and US Pharmacopeial Convention—in creating standards and enforcing laws and regulations. (Section 2.4)
5 Explain the role of state boards of pharmacy and the differences between state and federal laws as they apply to pharmacy. Paraphrase how the strictest rule is applied. (Section 2.4)
6 Define the specific legal term standard of care and its application to the pharmacist and pharmacy technician. (Section 2.6)
7 Explain the differences between criminal and civil law, how these laws affect the pharmacy profession, and the varying levels of liability of pharmacists and pharmacy technicians. (Section 2.7)
8 Explain and provide examples of the potential for legal actions against a pharmacy technician related to negligence, malpractice, or the law of agency and contracts. (Section 2.7)
ASHP/ACPE Accreditation Standards
To view the ASHP/ACPE Accreditation Standards addressed in this chapter, refer to Appendix B.
To be an effective pharmacy technician, you will need to understand the legal context in which you will practice. A variety of mechanisms control the practice of pharmacy, including a wide range of laws and ensuing regulations passed by federal, state, and local governmental entities. These legal mechanisms ensure that pharmaceutical manufacturers bring safe products to market, and that pharmacy personnel provide safe and effective care to consumers while staying safe themselves. In addition, various professional organizations have established standards that guide the manufacture of pharmacy products and the conduct of pharmacists and pharmacy technicians.
Any violations of pharmacy laws and standards may lead to adverse patient consequences—such as medication complications, injury, and even death—as well as personal consequences—such as legal action, loss of employment, and, in rare extreme cases, fines or jail. This chapter provides an overview of the complex system of interrelated pharmacy laws, regulations, and standards.