PTCB Laws and Regulations Practice Test

Questions and Answers

Which of these recalls would be issued by the Food and Drug Administration (FDA) for a medication that was deemed to cause temporary adverse health effects for patients that used that medication?

Class II Recall (correct)

Class III Recall

Class IV Recall

Class I Recall

Which member of the pharmacy staff is legally able to ask patients if they would like to be counseled on their medication?

Pharmacy intern, pharmacy technician, and pharmacist

Which of these laws states that all medication products must have directions for use and appropriate safety warnings?

Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA, FDCA, or FD&C)

Which of these methods is an acceptable way to store prescription records?

2 files: (CII) and (non-controlled + CIII-V) Signup and view all the answers

What is the appropriate form to use to order controlled substances from a pharmacy supplier?

DEA 222 form Signup and view all the answers

Which of these DEA numbers is valid?

CG2467896 Signup and view all the answers

How long do prescription records need to be retained onsite by a pharmacy?

2 to 5 years, depending on the state Signup and view all the answers

Study Notes

Recalls and Safety

Class II recall: issued for medications causing temporary or reversible adverse health effects, or with a small risk of serious effects.
Class I recall: when medication likely causes severe adverse effects or death.
Class III recall: unlikely to cause adverse effects.
Class IV recall does not exist; only three recall classes recognized by FDA.

Pharmacy Counseling Regulations

Any pharmacy staff member can inquire if a patient wishes to be counseled about their medication.
Only pharmacists are authorized to provide counseling.
Regulations may vary by state, with some requiring counseling for all new prescriptions by the pharmacist.

Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA)

Mandates all medication products must contain directions for use and safety warnings.
Requires FDA approval for all drugs before they can be marketed or used.
Improved upon the Pure Food and Drug Act by including necessary safety requirements.
Isotretinoin Safety and Risk Management Act of 2004 addresses Risk Evaluation and Mitigation Strategies (REMS) for drugs with serious risks.
Poison Prevention Packaging Act (PPPA) sets security standards for medication packaging to protect children.

Storage of Prescription Records

Acceptable methods for prescription record storage include:
- Two files: one for Controlled Substances Schedule II (CII) and the other for non-controlled and Schedule III-V.
- Options may also include two files for (CII-V) and non-controlled substances, or three separate files.

Ordering Controlled Substances

DEA 222 form: required for ordering controlled substances from suppliers or other pharmacies.
DEA 224 form: used to register a retail pharmacy with DEA.
DEA 106 form: necessary for reporting lost or stolen controlled substances.
DEA 41 form: used to document the destruction of controlled substances.

Validity of DEA Numbers

Valid DEA number example: CG2467896.
Validation process involves summing specific digits from the number and checking the final sum against the last digit.
First letter of DEA numbers has evolved; 'C' now typically denotes specialists rather than general practitioners.

Record Retention Requirements

Prescription records must be retained onsite for a minimum of 2 years; federal law suggests 5 years.
FDA reviews records back to 5 years.
Medicare prescriptions must be kept for 10 years.
Onsite retention may differ from general storage regulations, particularly for central storage offsite.

Description

Test your knowledge on PTCB laws and regulations with these flashcards. This practice test focuses on FDA recalls, including Class I and Class II recalls. Enhance your understanding of the regulatory aspects of pharmacy practice.