Oregon State Pharmacy Law Quiz

Pharmacy Law

Healthcare Compliance

NABP

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| By Happylamus

Happylamus

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Quizzes Created: 1 | Total Attempts: 500

| Attempts: 500 | Questions: 13 | Updated: Sep 9, 2025

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1. Under Division 7, the following are true regarding the SNS and State Stockpile Emergency Drugs.

The RSS, PODs and local health departments (LHD) are authorized to store any drugs from the SNS or state stockpile... The RSS, PODs and local health departments (LHD) are authorized to store any drugs from the SNS or state stockpile prior to and during an emergency without any registration from the Board

An Intake Form that shall serve as a valid prescription is to be filled out for each person receiving a... An Intake Form that shall serve as a valid prescription is to be filled out for each person receiving a drug at a POD

Returns: At the conclusion of the emergency, all such drugs are to be returned to the RSS or other designated... Returns: At the conclusion of the emergency, all such drugs are to be returned to the RSS or other designated location under instructions issued by OSPHD

All are true

Repackaging, administration, and distribution are done in the coordination of the Oregon State Public Health Department

Explanation

Repackaging, administration, and distribution are done in the coordination of the Oregon State Public Health Department

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2. Under division 7, Damage to a Pharmacy and Drug Integrity includes

Controlled substances damaged, lost or stolen shall be documented and reported to the DEA and the Board on DEA Form... Controlled substances damaged, lost or stolen shall be documented and reported to the DEA and the Board on DEA Form 41 or DEA Form 106 as appropriate

A pharmacy that is required to temporarily close or relocate due to an emergency must report this event to the... A pharmacy that is required to temporarily close or relocate due to an emergency must report this event to the Board within three working days.

For those drugs labeled for storage at “controlled room temperature,” the acceptable range of temperature is 68° to 77°F with... For those drugs labeled for storage at “controlled room temperature,” the acceptable range of temperature is 68° to 77°F with allowances for brief deviations between 59° to 86°F.

If a pharmacy loses power that affects temperature or humidity controls such that USP standards for proper storage of drugs... If a pharmacy loses power that affects temperature or humidity controls such that USP standards for proper storage of drugs have been violated, such drugs shall be classified as adulterated and may not be dispensed. Any incident of this nature must be reported to the Board within three working days

All are true

All the statements mentioned in the question are true. Under division 7, Damage to a Pharmacy and Drug Integrity, controlled substances that are damaged, lost, or stolen should be documented and reported to the DEA and the Board using the appropriate forms. If a pharmacy is required to temporarily close or relocate due to an emergency, it must report this event to the Board within three working days. The acceptable temperature range for drugs labeled for storage at "controlled room temperature" is 68° to 77°F, with brief deviations allowed between 59° to 86°F. If a pharmacy loses power and the USP standards for proper storage of drugs are violated, those drugs are considered adulterated and may not be dispensed. Any incident of this nature must be reported to the Board within three working days.

Explanation

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3. Under division 43, the difference between labeling for EPT and normal regulation for normal labeling is when a drug is dispensed in the practice of an Expedited Partner Therapy treatment protocol, the name of the patient or the patient's partner may be omitted from the label.

True

False

Under division 43, when a drug is dispensed in the practice of an Expedited Partner Therapy treatment protocol, the name of the patient or the patient's partner may be omitted from the label. This means that in such cases, the label does not need to include the name of the patient or their partner. Therefore, the statement "True" is correct.

Explanation

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4. Under Division 7, In an emergency, the Board may allow a pharmacist whose license has been inactive for no more than two years to reactivate their license without completing any required continuing education or MPJE. The license will revert to an inactive status at the end of six months unless all required continuing education has been completed. Keep in mind that all the emergency licensure only valid for 6 months, if the time exceeds 6 months, the Board shall renew it for another 6 months

True

False

Under Division 7, the Board has the authority to reactivate the license of a pharmacist whose license has been inactive for no more than two years in an emergency situation. This reactivation does not require the completion of any required continuing education or MPJE. However, it is important to note that this reactivated license will revert to an inactive status after six months if all required continuing education has not been completed. Additionally, if the emergency situation exceeds six months, the Board has the responsibility to renew the license for another six months. Therefore, the statement is true.

Explanation

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5. Under division 7, how should record keeping be exercised?

POD intake forms and Individual Data Collection Forms or electronic records shall be transferred to OSPHD at the end of... POD intake forms and Individual Data Collection Forms or electronic records shall be transferred to OSPHD at the end of the emergency

Vaccines: Logs shall be transferred to OSPHD within 14 days of administration to be entered into the statewide immunization information... Vaccines: Logs shall be transferred to OSPHD within 14 days of administration to be entered into the statewide immunization information system. If the Community Partner is a registered health-care facility or under the control of a licensed health-care provider, a copy of the log shall be made before submission and retained for three years

Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a pharmacy that is not a Temporary or Mobile... Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a pharmacy that is not a Temporary or Mobile Pharmacy shall be stored at the pharmacy

Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a Temporary or Mobile Pharmacy shall be stored at... Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a Temporary or Mobile Pharmacy shall be stored at whichever of the following locations is most appropriate: At the parent pharmacy that provided the majority of the drugs, At the pharmacy that employs the supervising pharmacist of the Temporary or Mobile Pharmacy or,

At the pharmacy that receives the unused drugs from the Temporary or Mobile Pharmacy at the end of the emergency

All are true

All of the statements provided in the options are correct. Under division 7, record keeping should be exercised in the following ways: POD intake forms and Individual Data Collection Forms or electronic records should be transferred to OSPHD at the end of the emergency. Vaccine logs should be transferred to OSPHD within 14 days of administration to be entered into the statewide immunization information system. Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a pharmacy that is not a Temporary or Mobile Pharmacy should be stored at the pharmacy. Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a Temporary or Mobile Pharmacy should be stored at the appropriate locations mentioned. Therefore, the answer "All are true" is correct.

Explanation

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6. Fill in the blank: Any person who is involved in the manufacture or wholesale distribution of a drug that is intended for distribution, dispensing or administration in Oregon, but who does not at any time have possession of any of the Active Product Ingredients (API) or the final product, and does not participate in the actual manufacturing process, must register under these rules as a_________ , except that any such person, registered with the FDA as a manufacturer, who is accountable to the FDA for the purity and integrity of a drug must register as a __________ under Division 60 of this chapter of rules.

Manufacturer

Drug Distribution Agent

A then B

B then A

“Manufacture” means the preparation, propagation, compounding, or processing of a drug or device intended for human or animal use. Manufacture includes repackaging or otherwise changing the container, wrapper, or labeling of any drug package in furtherance of the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user, except when the process is part of a shared pharmacy service agreement as defined in OAR 855-006-0005.

Any person who would otherwise be required to register as a wholesaler under Division 65 of this chapter of rules but who does not at any time have possession of a drug intended for distribution must register as a Drug Distribution Agent under this division of rules

Explanation

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7. Being a PIC requires that

You have at least 1 year of experience OR

Get the PIC training class done from the BOP within the first year of graduation

Get the PIC training class done from the BOP within 30 days of becoming a PIC

Notify the Board within 15 days of becoming or resigning from being a PIC

Get the PIC training class done from the BOP BUT it DOES NOT have to be within the first year of graduation

Explanation

Get the PIC training class done from the BOP BUT it DOES NOT have to be within the first year of graduation

Submit

8. Under division 7, the Emergency Pharmacy Rules includes all, BUT:

Refills: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may... Refills: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may dispense a refill of a prescription drug without a valid prescription provided that clinical judgement is exercised, it will not exceed 30 day supply, refill was documented as Emergency Prescriptions and the patient was informed that the refill was w/o the prescriber's authorization and further refills will require the prescriber's authorization

If the refill is for a controlled substance, permission has been granted by the DEA for this type of refill,... If the refill is for a controlled substance, permission has been granted by the DEA for this type of refill, either by waiver of appropriate controlled substance regulations or by notification to the Board

New and modified drug therapy: A pharmacist in the area covered by a declared emergency or in an area engaged... New and modified drug therapy: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may, without consultation with any authorized prescriber, initiate or modify any drug therapy, and dispense an amount of the drug to meet the patient’s health needs until that patient can be seen by a health-care practitioner

The pharmacist informs the patient or the patient’s agent at the time of dispensing that the drug is being provided... The pharmacist informs the patient or the patient’s agent at the time of dispensing that the drug is being provided in the absence of a valid patient — prescriber relationship but that a prescriber was consulted regarding the appropriateness of the drug therapy

New and modified drug therapy: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may, after consultation with any authorized prescriber, initiate or modify any drug therapy, and dispense an amount of the drug to meet the patient’s health needs until that patient can be seen by a health-care practitioner

Explanation

Submit

9. Under division 7, the temporary pharmacy will have all of these following applies, with the exception of

A Temporary Pharmacy Registration automatically expires when the state of emergency ends unless specifically extended by the Board.

Within 30 days of the end of the declared emergency, the holder of a Temporary Pharmacy Registration shall notify the... Within 30 days of the end of the declared emergency, the holder of a Temporary Pharmacy Registration shall notify the Board as to the disposition of its drug inventory and records.

He supervising pharmacist of a mobile pharmacy shall notify the Board of the pharmacy location within three working days of... He supervising pharmacist of a mobile pharmacy shall notify the Board of the pharmacy location within three working days of commencing business, and within three working days of any change in location

A temporary or mobile pharmacy that is established for the sole purpose of expediting distribution of emergency immunizations, antibiotics or... A temporary or mobile pharmacy that is established for the sole purpose of expediting distribution of emergency immunizations, antibiotics or antiviral drugs under OAR 855-007-0080, is located adjacent to an existing pharmacy registered with the Board and is under the supervision of the PIC of the existing pharmacy, still needs to be registered as a temporary pharmacy

A temporary or mobile pharmacy that is established for the sole purpose of expediting distribution of emergency immunizations, antibiotics or antiviral drugs under OAR 855-007-0080, is located adjacent to an existing pharmacy registered with the Board and is under the supervision of the PIC of the existing pharmacy, does not need to be registered as a temporary pharmacy

Explanation

Submit

10. Under division 62, which comments are true regarding the record keeping of drug distribution agent?

Records required under these rules must be maintained for three years

Records required under these rules must be maintained for two years

Records required under these rules that are less than 12 months old must be kept at the address of record... Records required under these rules that are less than 12 months old must be kept at the address of record or be immediately retrievable by computer or other electronic means, and must be immediately available for inspection.

Records required under these rules that are less than 13 months old must be kept at the address of record... Records required under these rules that are less than 13 months old must be kept at the address of record or be immediately retrievable by computer or other electronic means, and must be immediately available for inspection.

All other records required by these rules must be made available for inspection within three business days of a request

Record Keeping

(1) A Drug Distribution Agent must establish and maintain records of all transactions regarding the distribution or other disposition of a drug. These records must comply with all federal drug laws and regulations and must include the following information:

(a) The source of the drug, including the name and physical address of the seller or transferor and any broker or other person involved in the transaction, the address of the location from which the drug was shipped and the address of the location to which the drug was shipped;

(b) The name, dose and quantity of the drug distributed;

(c) The date of distribution or other disposition of the drug.

(2) Records required by this rule must be made available for inspection and copying by any authorized official of the Drug Enforcement Agency, the Food and Drug Administration, the Department of Agriculture, authorized law enforcement agencies, and this Board.

(3) Records required under these rules must be maintained for three years.

(4) Records required under these rules that are less than 13 months old must be kept at the address of record or be immediately retrievable by computer or other electronic means, and must be immediately available for inspection. All other records required by these rules must be made available for inspection within three business days of a request.

Explanation

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11. What are the procedures that only a pharmacist is allowed to do?

Verify prescriptions

CDTM, DRR, or MTM

DUR

Review laboratory tests (monitor, interpret, and/or order these tests)

Immunizations

Receiving oral prescriptions

Counseling

Note: counseling, immunizations, DUR, and receiving oral prescriptions can all be done by an intern as well as a pharmacist]

Explanation

Note: counseling, immunizations, DUR, and receiving oral prescriptions can all be done by an intern as well as a pharmacist]

Submit

12. Under division 62, registration for drug distribution agent should:

The registrant must notify the Board, within 10 days, of any substantial change to ownership, business address, Any... The registrant must notify the Board, within 10 days, of any substantial change to ownership, business address, Any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers

The registrant must notify the Board, within 15 days, of any substantial change to ownership, business address, Any... The registrant must notify the Board, within 15 days, of any substantial change to ownership, business address, Any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers

Have an applicant for renewal must complete the form provided by the Board and submit it to the Board with... Have an applicant for renewal must complete the form provided by the Board and submit it to the Board with the appropriate fee by August 31 annually.

The registration certificate is issued to a specific person and is non-transferable

Have been defined as a pharmaceutical manufacturer that has entered into an agreement with another pharmaceutical manufacturer to engage in... Have been defined as a pharmaceutical manufacturer that has entered into an agreement with another pharmaceutical manufacturer to engage in a business activity or occupation related to the manufacture or distribution of a prescription drug.

"Co-Manufacturing Partner" means a pharmaceutical manufacturer that has entered into an agreement with another pharmaceutical manufacturer to engage in a business activity or occupation related to the manufacture or distribution of a prescription drug.

Explanation

Submit

13. Under division 65, which is true about drug wholesalers?

As a part of the registration or re-registration application, an applicant for registration as a Class I Wholesaler must name... As a part of the registration or re-registration application, an applicant for registration as a Class I Wholesaler must name a Designated Representative (DR) for each wholesale distributor registered under these rules

The DR must conduct a self-inspection of the facility by September 1 each year,

This form must be retained for three years and must be made available to the Board within two days upon... This form must be retained for three years and must be made available to the Board within two days upon request.

This form must be retained for three years and must be made available to the Board within three days upon... This form must be retained for three years and must be made available to the Board within three days upon request.

As a condition for receiving and retaining a wholesale distributor registration issued under these rules, an applicant must satisfy the... As a condition for receiving and retaining a wholesale distributor registration issued under these rules, an applicant must satisfy the Board that the applicant has and will continuously maintain acceptable storage and handling conditions and facilities standards for each facility at which drugs are received, stored, warehoused, handled, held, offered, marketed, or displayed, or from which drugs are transported

"Wholesale Distributor" means any entity engaged in the wholesale distribution of drugs, including any entity whose business name appears on any invoice or other type of shipping document indicating possession or title. The term "Wholesale Distributor" includes but is not limited to, own-label distributors; private-label distributors; warehouses, including manufacturers' and distributors' warehouses; drug wholesalers or distributors; independent wholesale drug traders; third-party logistics providers; cooperative pharmacy warehouses; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Wholesale Distributor must also be listed as an Authorized Distributor of Record for that manufacturer.

(24) "Wholesaler" means any wholesale distributor:

(a) "Class I Wholesaler" means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which prescription drugs, medicinal chemicals, or poisons are sold, dispensed, stocked, exposed or offered for sale at wholesale to a pharmacy or other legally licensed drug outlets or persons;

(b) "Class II Wholesaler" means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which any of the products in paragraphs (A) – (D) below are stored, or offered for sale or distribution at wholesale to a drug outlet or practitioner legally authorized to resell, distribute, dispense or administer:

Explanation

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