Pharmacy Law: USP Standards, Controlled Substances, and Federal Regulations

USP Chapter 795

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

USP Chapter 797

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

USP Chapter 800

A USP chapter that provides the minimum standard for handling hazardous products

Controlled Substances Act (CSA)

A federal statute that established a policy to regulate the manufacture, distribution, importing/exporting, and use of regulated substances.

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)

DEA Form 222

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

Controlled Substance Ordering System (CSOS)

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

Schedule I

Includes drugs, substances, or chemicals with no currently accepted medical use and a high potential for abuse.

Schedule II

Includes drugs, substances, or chemicals with a high potential for abuse, with use potentially leading to severe psychological or physical dependence.

Schedule III

Includes drugs, substances, or chemicals with a moderate to low potential for physical and psychological dependence.

Schedule IV

Includes drugs, substances, or chemicals with a low potential for abuse and low risk of dependence.

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.

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)

Health Insurance Portability and Accountability Act (HIPAA) of 1996

A federal law that established national standards to protect patient privacy

Drug Enforcement Administration (DEA)

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

DEA number

A unique identifier assigned to healthcare providers by the DEA to allow them to prescribe controlled substances.

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

Occupational Safety and Health Administration (OSHA)

A federal agency that requires employers to provide safe working conditions

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.

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

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

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

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

Medicare Modernization Act (MMA)

A federal law that overhauled Medicare and created Medicare Part D

Omnibus Budget Reconciliation Act of 1990 (OBRA '90)

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

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

Safety Data Sheet (SDS)

An information sheet that is required for each hazardous chemical.

Medication Guide

Patient labeling that is part of the FDA-approved prescription drug labeling for certain prescription drugs.

Patient Package Insert (PPI)

Patient labeling that can be part of FDA-approved prescription drug labeling.