1 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. Chapter 2 Pharmacy Law, Standards and Ethics for Technicians How Laws and Agencies shape the Pharmacy Industry

2 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. Introduction Pharmacy Law: The methodologies and procedures that are governed by a variety of interrelated laws and regulations that work together to promote safety and protection to the public.

3 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. Laws and Agency Description 1. Common Law-the system of guides and standards established by decisions in cases throughout the legal history. 2. Statutory Laws-are passed by legislative bodies of federal, state and local levels. Example: Federal law- Morphine is regulated by the DEA. State law- Texas law against Ephedrine (speed) due to the structural similarity of methamphetamine. Local- County laws have banned pseudoephedrine (Sudafed) because it contains ephedrine.

4 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. Laws and Agency Description 3. Regulatory Laws-is the system of rules and regulations established by governmental bodies at the State and Federal level. Examples: FDA State Board of Pharmacy DEA OSHA

5 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. Laws and Agency Description 4. State Board of Pharmacy -regulates the practice of Pharmacy. Each state has its own board of pharmacy. The Texas SBP oversees pharmacy laws, make amendments, create new regulations, and also inspects for compliance. When federal law and state law differ, federal law usually prevails.

6 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. History Pharmacy Laws (See Laws Related to Pharmacy Handout #6) 1. Pure Food and Drug Act of 1906-Prohibits the sale of adulterated (filthy, poisonous, unsafe, unsanitary) or mislabeled (misleading) food, drinks, and drugs. 2. Food, Drug, and Cosmetic Act (FDCA) of 1938 The Food and Drug Administration (FDA) was created. FDA is primarily responsible for drug safety. Has authority to enforce law and regulations. Has authority to recall drugs also known as a Class I, II, III recall. Requires scientists to conduct 3 phases of testing to qualify drugs for approval.

7 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. History Pharmacy Laws 3. Durham-Humphrey Amendment of Kefauver-Harris Amendment of 1962

8 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. History Pharmacy Laws 5. Comprehensive Drug Abuse Prevention and Control Act of 1970 commonly known as the Controlled Substance Act of 1970  Drug Enforcement Agency (DEA) was created.  DEA duties include: Enforcing laws regarding addictive substances. Devoted to fighting the War-on-Drugs in the illegal trafficking of C-I drugs. Issues doctors a DEA license number to write Rx for controlled substances. Conduct pharmacy inspections-usually physically count Schedule II drugs.

9 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. Controlled Substances (See Schedule Drugs Handouts #7) -Controlled substances are placed into Schedules (Classes) I-V based on potential abuse.  Schedule I or CI-No accepted medicinal use with the highest abuse potential.  Schedule II or CII-Accepted medicinal use with a high abuse potential and dependency. -These drugs may NOT be refilled. -Requires a DEA 222 form. (Lecture 3)  Schedule III or CIII-Accepted medicinal use with a moderate abuse potential or dependency.  Schedule IV or CIV-Accepted medicinal use with a low abuse potential and dependency.  Schedule V or CV-Drugs that have the lowest potential for abuse and dependency.

10 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. History Pharmacy Laws 6. Poison Prevention Act of Drug Listing Act of 1972 Required the FDA to assign each new drug a unique and permanent code known as the National Drug Code (NDC number). (See NDC number Handout #5) 8. Orphan Drug Act of Drug Pricing Competition and Patent-Term Restoration Act of 1984

11 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved.

12 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. History Pharmacy Laws 10. Prescription Drug Marketing Act of 1988 Banned the sale, trade, or purchase of drug samples. This was also the year that the FDA was established as an agency of the Department of Health and Human Services. 11. Omnibus Budget Reconciliation Act of 1990 (OBRA-90) 12. Dietary Supplement Health and Education Act of 1994 (DSHEA) 13. Health Insurance Portability and Accountability Act of 1996 (HIPAA) 14. Occupational Health and Safety Administration (OSHA)

13 Copyright © 2011, 2007, 2003, 1999 by Saunders, an imprint of Elsevier Inc. All rights reserved. END