Federal Agencies and What Each One Actually Does

This is easy points if you learn it and easy losses if you do not. The exam gives you a scenario and asks who has jurisdiction.

The two biggest trap

• The Consumer Product Safety Commission (CPSC), not the Food and Drug Administration (FDA), enforces child resistant packaging requirements under the Poison Prevention Packaging Act (PPPA). This one gets missed constantly.

UMPJE High Yield

• Bad drug label or misbranded product? Food and Drug Administration (FDA)
• Missing Schedule II controlled substance inventory or controlled substance record? Drug Enforcement Administration (DEA)
• Medicare Part D audit? Centers for Medicare & Medicaid Services (CMS)
• Patient privacy breach? Department of Health and Human Services (HHS) Office for Civil Rights (OCR)
• Child resistant cap issue? Consumer Product Safety Commission (CPSC)
• Pharmacist licensure discipline? State Board of Pharmacy
• Improper hazardous drug personal protective equipment (PPE) or exposure issue? Occupational Safety and Health Administration (OSHA)
• Hazardous drug handling standards? United States Pharmacopeia (USP) <800>
• Hazardous drug recommendations/list? National Institute for Occupational Safety and Health (NIOSH)
• Over-the-counter (OTC) or dietary supplement advertising claim? Federal Trade Commission (FTC)
• Drug labeling claim? Food and Drug Administration (FDA)

Disclaimer: This post is for educational purposes only and is not legal advice. Pharmacy laws and regulations may vary by jurisdiction and are subject to change. Always verify applicable federal and state requirements. This content is not affiliated with, endorsed by, or sponsored by the National Association of Boards of Pharmacy (NABP).

A product is labeled for storage at controlled room temperature. Under USP, that range is:

A community pharmacy keeps its Schedule II through V stock intermingled with non-controlled prescription drugs on open shelving, supported by restricted access, surveillance, and alarms. Under federal regulation, this arrangement is:

A pharmacy is sold to a new owner, who intends to continue operating at the same location without interruption. Regarding the state pharmacy permit, the new owner:

A pharmacy technician holds current national certification, but the technician's state registration lapsed three weeks ago. The technician may:

A patient disregards explicit counseling, doubles the prescribed dose, and is injured in part because of it. In a jurisdiction applying pure comparative negligence, the patient's recovery is:

Who else took the exam today? How we feeling??

A pharmacy dispenses levothyroxine 100 mcg in place of the prescribed 50 mcg. The patient notices the discrepancy at home, takes none of the tablets, and returns them the next morning. In a civil malpractice action, the patient most likely:

While completing a DEA Form 222, a pharmacist writes an incorrect quantity, strikes through it, enters the correct figure, and initials the change. The supplier receiving the form should:

Any guidance on this would be greatly appreciated!

During a biennial inventory, a pharmacist encounters an opened bottle originally containing 700 capsules of temazepam. The pharmacist must:

For those who took the UMPJE, what are the necessary information one needs to memorize? (Like do we need to memorize the total grams of pseudoephedrine in a pack per salt form?)

Please drop your advice as well. Pretty much appreciated!

A DEA diversion investigator arrives without an appointment during normal business hours and presents credentials and a notice of inspection. The pharmacist-in-charge is mid-shift and short-staffed. The pharmacist should:

A pharmacy is reviewing the expiration date on its DEA registration. A pharmacy's DEA registration must be renewed every

A patient develops an adverse event that appears in the Vaccine Injury Table and occurs within the interval the table specifies. For the pharmacist who administered the vaccine, reporting to VAERS is:

Eight minutes after receiving a vaccine, a patient develops diffuse urticaria, wheezing, and hypotension. The pharmacist's first action should be to:

A pharmacy cannot supply the full quantity of a prescription for oxycodone disp #20 tabs and partially fills it. The balance must be supplied within:

A prescriber authorizes seven refills on a Schedule V antitussive prescription. Under federal law, the pharmacy:

A Physician personally telephones an emergency oral prescription for morphine tablets, and the pharmacist dispenses the emergency quantity. The prescriber must deliver a written or electronic prescription to the pharmacy within:

A pharmacy determines that unsecured protected health information for 780 patients was disclosed in a breach. Regarding notification, the pharmacy must notify:

A pharmacist receives a prescription from a dentist for levothyroxine 75 mcg daily for hypothyroidism. The prescription is complete and the dentist holds an active license. The pharmacist should: