PTCB Laws and Regulations

USP Chapter 797

provides the minimum standard for compounding sterile products

Schedule I

Includes 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

Omibus Budget Reconciliation Act of 1990 (OBRA ‘90)

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

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

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

Drug recall classes

Class I: Recalls for products that have a reasonable probability of causing severe injury or death
Class II: Recalls for products that could pose a moderate danger to the public and may cause medically reversible or temporary adverse health events
Class III: Recalls for products that could pose little to no probability of an adverse health event

Health Insurance Portability and Accountability Act (HIPAA) of 1996

a federal law that established national standards to protect patient privacy

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

Poison Prevention Packaging Act of (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

Controlled Substance 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

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

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

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)

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

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)

DEA number

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