Laws and Regulations

Food and Drug Administration (FDA)

A federal agency that works to ensure the safety and effectiveness of human and veterinary medicines, biologics, and medical devices. They also regulate the safety of food, cosmetics, devices that emit radiation, and tobacco products

Schedule V

Includes drugs, substances, or chemicals with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, or analgesic purposes. Some examples of Schedule V drugs are: pregabalin, diphenoxylate/atropine, and cough preparations with less than 200 mg of codeine ( lowest potential of abuse and dependence)

Controlled Substance Ordering System (CSOS)

A system that allows for secure electronic transmission of controlled substance orders without the supporting paper DEA Form 222

Medication Guide

Patient labeling that is part of the FDA-approved prescription drug labeling for certain prescription drugs. Medication Guides (MGs) are developed by applicants, approved by FDA, and required to be distributed to patients ( explains serious risks, side effects, and safe use instructions)

National Association of Boards of Pharmacy (NABP)

An independent, international, and impartial organization that helps member boards and jurisdictions develop, implement, and enforce uniform standards to protect public health

Drug Supply Chain Security Act (DSCSA)

A federal regulation that outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain

Controlled substances schedules

There are five schedules of controlled substances: I (most potential for addiction/use disorder) to Schedule V (least potential for addiction/use disorder)

USP Chapter 797

A USP chapter that provides the minimum standard for compounding sterile products

Drug recall Class 1

Class I: Recalls for products that have a reasonable probability of causing severe injury or death

Drug Recall Class 2

Recalls for products that could pose a moderate danger to the public and may cause medically reversible or temporary adverse health events

Drug Recall Class 3

Recalls for products that could pose little to no probability of an adverse health event

Patient Package Insert (PPI)

Patient labeling that can be part of FDA-approved prescription drug labeling. PPIs are required for oral contraceptives and estrogens, and voluntary for all other medications ( how to use a prescription medication safely and effectively)

DEA number

A unique identifier assigned to healthcare providers by the DEA to allow them to prescribe controlled substances. The format consists of two letters and seven numerical digits

Health Insurance Portability and Accountability Act (HIPAA) of 1996

A federal law that established national standards to protect patient privacy

Controlled Substances Act (CSA)

A federal statute that established a policy to regulate the manufacture, distribution, importing/exporting, and use of regulated substances. The act also placed all substances that were in some manner regulated under existing federal law into one of five schedules

Drug recall

A method of removing or correcting products that may cause harm or otherwise violate laws administered by the Food and Drug Administration (FDA)

Occupational Safety and Health Administration (OSHA)

A federal agency that requires employers to provide safe working conditions

Legend drug

Any drug that is habit-forming or potentially harmful and must therefore be dispensed under the supervision of a health practitioner; a prescription-only medication

USP Chapter 800

Provides the minimum standard for handling hazardous products

Schedule I

ncludes drugs, substances, or chemicals with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (ecstasy)

Combat Methamphetamine Epidemic Act (CMEA) of 2005

A federal law that regulates the retail sale of drugs containing ephedrine, pseudoephedrine, or phenylpropanolamine to 3.6 g per day and no more than 9 g in a thirty day period

Safety Data Sheet (SDS)

An information sheet that is required for each hazardous chemical. The SDS includes information such as the properties of each chemical; the physical, health, and environmental health hazards; protective measures; and safety precautions for handling, storing, and transporting the chemical

Poison Prevention Packaging Act (PPPA) of 1970

A federal law that requires child-resistant packaging for most legend and over-the-counter (OTC) drugs to prevent accidental ingestion and poisoning

Drug Enforcement Administration (DEA)

A federal law enforcement agency that was set up in 1973 to implement drug use laws and fight drug trafficking

USP Chapter 795

A USP chapter that provides the minimum standard for compounding nonsterile products

Risk Evaluation and Mitigation Strategy (REMS)

A drug safety program that can be required by the FDA for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks

Omnibus Budget Reconcilation Act of 1990 (OBRA '90)

A federal statute that requires pharmacists to offer patient counseling to Medicaid patients

Schedule IV

Includes drugs, substances, or chemicals with a low potential for abuse and low risk of dependence. Some examples of Schedule IV drugs are: alprazolam, zolpidem, and tramadol

Schedule II

Includes drugs, substances, or chemicals with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II drugs are: cocaine, fentanyl, and methylphenidate

Medicare Modernization Act (MMA)

A federal law that overhauled Medicare and created Medicate Part D

Schedule III

Includes drugs, substances, or chemicals with a moderate to low potential for physical and psychological dependence. Some examples of Schedule III drugs are: products containing less than 90 mg of codeine per dosage unit (e.g., acetaminophen with codeine), ketamine, and anabolic steroids

DEA Form 222

A form used by eligible registrants to order Schedule I or II controlled substances