DAW Codes and Regulations

Schedule I (C-I)

High potential for abuse; NO accepted medical uses

Schedule II (C-II)

High potential for abuse and physical or psychological dependence; accepted medical use

Schedule III (C-III)

Moderate potential for abuse and can lead to moderate or low physical dependence or high psychological dependence

Schedule IV (C-IV)

Low potential for abuse and only a limited physical or psychological dependence

Schedule V (C-V)

Lowest potential for abuse and limited physical or psychological dependence; usually contain a limited amount of a controlled substance combined with noncontrolled active ingredients

DEA Number

Number assigned to a prescriber that documents their authority to prescribe controlled substances; pharmacies are also assigned DEA numbers that document their authority to stock and dispense controlled substance

DEA Form 41

Form used by pharmacies to initiate the destruction of controlled substances

DEA Form 106

Form used by pharmacies in the event of theft of controlled substance

DEA Form 222

Form used by DEA registrants to order or transfer controlled substances (Schedule II)

Controlled Substance Act (1970)

Regulates the manufacture, inportation, possession, use, and distribution of medications and substances that have the potential for abuse and physical and/or psychological dependence.

The Joint Commission (TJC)

An organization that sets standards and accredits organizations while also providing certification for disease-specific care, advanced disease-specific care, and palliative care.

Center for Medicare and Medicaid Services (CMS)

A U.S. federal agency under the Department of Health and Human Services (DHHS) that provides health insurance coverage through Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace.

Occupational Safety and Health Administration (OSHA)

An agency of the U.S. Department of Labor that ensures safe and healthful working conditions by establishing and enforcing standards. Requires that pharmacies maintain Safety Data Sheets for all hazardous medications and compounds present in the pharmacy.

Food and Drug Administration (FDA)

A U.S. federal agency that supervises the development, testing, purity, safety, and effectiveness of prescription and over-the-counter medications.

Durham-Humphrey Amendment of 1951

Requires all products to have adequate directions for use unless they contain the federal legend “Caution: Federal law prohibits dispensing without a prescription.” This legislation clearly distinguishes prescription medications from OTC medications.

Kefauver-Harris Amendment of 1962

Enacted to ensure that all medications are pure,safe, and effective. It gave the FDA the authority to require proof of efficacy instead of only safety prior to approving new medication therapy.

Comprehensive Drug Abuse Prevention and Control Act of 1970

Regulates manufacturing, distribution, prescribing, and dispensing of controlled substances through the Drug Enforcement Administration (DEA).

Poison Prevention Packaging Act of 1970

Overseen by the Consumer Product Safety Commission, which requires most prescriptions for oral use to be dispensed in child-resistant containers unless patients or prescribers request otherwise.

Drug Listing Act of 1972

All medications are assigned a specific 10-digit identification number known as a National Drug Code (NDC). The first four digits identify the manufacturer, the next four digits identify the medication product, and the final two digits represent the package size.

Omnibus Budget Reconciliation Act of 1990

Requires pharmacists to keep records of all medications used by Medicaid patients which helps reduce the incidence of medication therapy problems due to duplication, allergies, medication interactions, medication side effects, and patients’ misuse or abuse of prescribed medications. Also requires pharmacists to offer to counsel all Medicaid patients about the proper use of their medications.

Anabolic Steroid Control Act of 1990

Classified anabolic steroids as Schedule III controlled substances.

Medicare Modernization Act of 2003

Provides voluntary prescription medication benefits to Medicare beneficiaries. It also added preventive medical benefits for older adults.

Combat Methamphetamine Epidemic Act of 2005

Created a new category of products called scheduled listed chemical product (SLCP). SLCP includes any product that may be marked as nonprescription medication that contains ephedrine, pseudoephedrine, or phenylpropanolamine. This act also placed limits on daily and monthly sales of these products and required identification of those seeking to purchase the product.

Drug Supply Chain Security Act of 2013

Outlines the critical steps to build a system to identify and trace prescription medications as they are distributed throughout the U.S.

United States Pharmacopeia (USP)

Establishes standards for the identity, strength, quality and purity of medicines, food ingredients, and dietary supplements.

USP-National Formulary (USP-NF)

Contains the standards for chemical and biological drug substances, dosage forms, compounder preparations, excipients, medical devices, and dietary supplements. All medications marketed in the U.S. must conform to these standards.

Institute for Safe Medication Practices (ISMP)

A nonprofit organization dedicated to preventing medication errors. It serves as an educating body for health care professionals and consumers regarding safety and error prevention through newsletters, recommendations, and safety alerts.

USP-Drug Information (USP-DI)

Two versions; Advice for the Patient, which contains easy-to-understand information about prescription medications for the nonmedical person: how to take medications, what they will do, and their side effects; for Health Care Prefessional, which contains more detailed technical information.

American Hospital Formulary Services Drug Information (AHFS-DI)

A cornerstone in pharmacy practice and medicine due to the critically evaluated, evidence-based, and comparative collection of medication monographs on practically every single-drug entity available in the U.S.

Drug Facts and Comparisons

An encyclopedia of medications that contains many facts about products and makes comparisons among them.

Physicians’ Desk Reference (PDR)

List more than 4,000 current brand-name and generic medications with descriptions and information on their usage, warnings, medication interactions, category, and more than 2,000 life-size, color photos.

Handbook on Injectable Drugs

A key reference used in hospital or home-infusion settings that discusses storage requirements and general information, including pH, freezing, exposure to light, and repackaging information. Info is based on the results of primary research of parenteral medication stability and compatibility.

Handbook on Nonprescription Drugs

An essential reference that lists the safety and effectiveness of nonprescription medications, herbal remedies, homeopathic products, nutritional supplements, and home medical equipment. It features brief descriptions of medication classes, usage, dosing and administration, case studies, and patient counseling suggestions.

Red Book

Provides formulary management and cost containment information. Contains average wholesale price information for brand-name and generic medications. Online reference.

Micromedex

A web application that addresses medication disease and toxicology management and formulary management. The user can enter patient care notes and have access to medication fact sheets.

Lexicomp Online

A comprehensive source of information that is used to find information that includes appropriate dosing and administration of a medication. Provides warnings and precautions associated with each medication.

Epocrates Online

Provides medication and disease information, medication interactions, a pill identifier, and guidelines in the treatment of various health conditions and diseases.