Federal requirements ptcb 2026 noquack

Prescription transfer between pharmacies

According to federal law, a prescription may be transferred no more than one time between pharmacies that do not share a real-time, online database.

Puncture-resistant container for needle disposal

The puncture-resistant container used for needle disposal is referred to as a sharps container.

Recall type for inactive Proventil HFA inhaler

If a Proventil HFA inhaler contains no active ingredient, a Class I recall should be assigned.

OTC products requiring ID under Combat Methamphetamine Epidemic Act

Patients must sign a log and provide valid photo identification to purchase OTC products containing pseudoephedrine.

Record retention for controlled substances

Pharmacies must maintain records for each controlled substance for a minimum of 2 years.

Class I recall definition

A Class I recall is issued when the use of an adulterated drug product is believed to cause serious adverse effects or death.

iPLEDGE program association

The iPLEDGE restricted drug distribution program is associated with isotretinoin.

Cleanup for hazardous material spill

A spill kit with usage policy must be on hand to contain and clean up hazardous material spills.

Hazardous drug requiring special handling

Cisplatin is a hazardous drug that requires special handling.

Prescription label requirements for controlled substances

The prescription label for a controlled substance must contain the name and address of the prescriber.

Agency requesting pharmaceutical recalls

The FDA is the federal government agency allowed to request a recall of a pharmaceutical.

Recall type for expiration date error

If there is an error in a medication's expiration date on the manufacturer's label, the FDA is most likely to request a Class II recall.

Organization enforcing medication disposal practices

The EPA is tasked with enforcing proper medication disposal practices to prevent contamination of waterways.

Safety Data Sheet requirement

A Safety Data Sheet is required by federal law to provide instruction for any hazardous chemical kept in the pharmacy.

Inventory retention for controlled substances

According to the DEA, original and transferred prescriptions for controlled substances must be maintained for at least 2 years from the date of the last refill.

Drug labeling requirements under DSCSA

According to the Drug Supply Chain Security Act, a medication package must be labeled with the NDC, lot number, expiration date, and a serial number.

Ordering stock bottles of controlled substances

Pharmacies must order stock bottles of medications like Morphine using CSOS or a paper equivalent.

Class I recall risk

A drug recall that is most likely to result in severe adverse health consequences or death upon exposure is known as a Class I recall.

FDA requirement for drugs with safety concerns

The FDA requires manufacturers of drugs with safety concerns to develop a Risk Evaluation and Mitigation Strategy (REMS).

Controlled substances inventory frequency

According to federal law, a complete inventory of controlled substances in a pharmacy must be made every 2 years.

Handling hazardous substances

Handling hazardous substances should be done while wearing personal protective equipment.

Reporting theft or loss of controlled substances

The theft or loss of significant quantities of controlled substances must be reported to the DEA.

Refilling Schedule III controlled substances

Prescriptions for Schedule III controlled substances may be refilled for up to 6 months if indicated.

Tracing documentation for borrowed medication

A transaction statement may serve as tracing documentation when a pharmacy borrows noncontrolled medication from another pharmacy.

Controlled substances inventory completion frequency

According to the DEA, a complete and accurate inventory of controlled substances must be completed every 2 years.

Classification of hazardous drugs

According to NIOSH and ASHP, a drug should be classified as hazardous if it causes teratogenicity.

Class III recall example

A package label stating 100 tablets but containing only 95 tablets would most likely cause a Class III recall.

Record retention for controlled substances distribution

According to the Code of Federal Regulations, records regarding the distribution, receipt, or destruction of controlled substances must be maintained for a minimum of 2 years.

Federal regulation of pharmaceutical waste disposal

Pharmaceutical waste disposal is regulated by the federal Resource Conservation and Recovery Act.

Transferring prescriptions for controlled substances

According to federal law, a prescription for Alprazolam may be transferred to another pharmacy to be refilled.

New controlled substance prescription requirements

A new controlled substance prescription must include the prescriber's DEA number.

Medication Guide requirement by FDA

The FDA may require a Medication Guide to be dispensed as part of a REMS program.

Transferring outdated Schedule IV controlled substances

A pharmacy transferring an outdated Schedule IV controlled substance to a reverse distributor for destruction should complete a DEA Form 41.

Medical device safety alerts

Medical device safety alerts are issued by the FDA when a device may present an unreasonable risk of substantial harm.

DEA schedule for Duragesic patches

A prescription for Duragesic patches should be filed under DEA schedule II.

Storage of Schedule II prescriptions

According to federal law, hard copies of prescriptions for Schedule II drugs must be stored in a file separate from other prescription records.

Tracking medication purchases with MethCheck

Purchases of pseudoephedrine may be tracked using MethCheck.

Dispensing isotretinoin after pregnancy test

Isotretinoin must be dispensed within 7 days of a negative pregnancy test for patients of childbearing potential.