Oregon State Pharmacy Law Quiz

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

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

Explanation

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.

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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.

Explanation

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.

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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

Explanation

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.

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

Explanation

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.

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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.

Explanation

“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

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7. Being a PIC requires that 

Explanation

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

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

Explanation

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

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

Explanation

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

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

Explanation

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.

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

Explanation

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

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

Explanation

"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.

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

Explanation

"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:

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  • Jul 16, 2012
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Under Division 7,  the following are true regarding the SNS and...
Under division 7, Damage to a Pharmacy and Drug Integrity includes
Under division 43, the difference between labeling for EPT and normal...
Under Division 7, In an emergency, the Board may allow a pharmacist...
Under division 7, how should record keeping be exercised?
Fill in the blank:...
Being a PIC requires that 
Under division 7, the Emergency Pharmacy Rules includes all,...
Under division 7, the temporary pharmacy will have all of these...
Under division 62, which comments are true regarding the record...
What are the procedures that only a pharmacist is allowed to do?
Under division 62, registration for drug distribution agent should:
Under division 65, which is true about drug wholesalers? 
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