Federal

Question 1

What is a Risk Evaluation and Mitigation Strategy (REMS)?

Answer 1

A REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) may require for certain medications with serious safety concerns. It ensures that the benefits of the medication outweigh its risks.

Question 2

What is the purpose of a REMS?

Answer 2

• Objective: REMS are designed to reinforce medication use behaviors and actions that support the safe use of the medication. They focus on preventing, monitoring, and/or managing specific serious risks.
• Scope: REMS do not address all adverse events; these are communicated through the medication’s prescribing information. REMS specifically target particular serious risks.

Question 3

What are the key components of a REMS?

Answer 3

• Risk Mitigation Goal: The primary aim of the REMS.
• Communication and Activities: Includes information and activities required of participants (e.g., healthcare providers, pharmacists, patients) who prescribe, dispense, or take the medication.
• Safety Strategy: Comprises the goal, communications, and/or activities to address specific safety concerns.

Question 4

How are REMS tailored for specific medications?

Answer 4

Each REMS is tailored to the medication, its risks, and the setting in which it is used. The roles of participants and specific requirements may vary based on the medication’s safety concerns.

Question 5

What policy applies to all emergency kits, including electronic ones?

Answer 5

• Policy Statement: Emergency kits must satisfy the criteria outlined in Appendix H and remain subject to its policy statement. They must be used for emergencies as defined by the state.
• Controlled Substances: A controlled substance in an emergency kit can only be dispensed with a valid prescription or medical order per CSA and DEA regulations (21 U.S.C. 841(a)(1), 21 CFR 1306.04(a), 21 CFR 1300.01(b)).

Question 6

What are the requirements for dispensing controlled substances from an emergency kit in a long-term care facility (LTCF)?

Answer 6

• Prescription Requirement: Controlled substances cannot be dispensed from the kit without a valid prescription received by the pharmacist as per 21 CFR 1306.11 and 1306.21.
• Prescription Validity: Must be issued for a legitimate medical purpose by a practitioner in the usual course of professional practice. The pharmacist is responsible for ensuring this validity.

Question 7

What happens if an emergency kit is used for purposes other than defined emergencies?

Answer 7

Kit Status: If a kit is used for non-emergency purposes, it ceases to be classified as an emergency kit. Separate registration requirements then apply.

Question 8

What guidelines must be followed for emergency kits with controlled substances in non-DEA registered LTCFs?

Answer 8

Source of Controlled Substances:

Obtain from a DEA-registered hospital/clinic, pharmacy, or practitioner.
Security Safeguards:

Define access controls and limitations on the type and quantity of controlled substances.
Control and Accountability:

Maintain complete records of controlled substances, their disposition, and periodic inventories.
Emergency Conditions:

Controlled substances can only be administered under specific medical conditions by authorized personnel, with adherence to 21 CFR 1306.11 and 1306.21.
Prohibited Activities:

Violations may lead to state revocation, denial, or suspension of the privilege to supply or possess emergency kits with controlled substances.

Question 9

Where can additional information on emergency kits in LTCFs be found?

Answer 9

Federal Register Notice: Requirements for emergency kits were published on April 9, 1980. Consult 45 FR 24128 for compliance details.

Question 10

What are the requirements for a covered entity to provide its notice?

Answer 10

1. A covered entity must make its notice available to any person who asks for it.
2. The notice must be prominently posted and available on any website the covered entity maintains that provides information about its customer services or benefits.
3. The notice may be e-mailed to an individual if the individual agrees to receive an electronic notice.

Question 11

What should we do if a DEA Form 222 is lost or stolen?

Answer 11

1. Execute a New Form: The registrant must complete another DEA Form 222.
2. Attach a Statement: The new form must be accompanied by a statement that includes:
   
   • The order form number and date of the lost or stolen form.
   • An indication that the goods covered by the first DEA Form 222 were not received.
3. Retention: A copy of the new form and the statement must be retained with a copy of the initial form.
4. Supplier Copy: The statement must be attached to the copy of the new form sent to the supplier.
5. If the Original is Found: If the original lost or stolen DEA Form 222 is located, the supplier must mark “Not Accepted” on the face of the form and return it to the registrant with the statement.

Additional Reporting Requirements:
1. Report Loss or Theft: The registrant must immediately report the loss or theft of used or unused order forms to the local DEA Diversion Field Office, including the serial numbers of each lost or stolen form.
2. Recovered Forms: If an unused order form is later recovered, the registrant must notify the local DEA Diversion Field Office immediately.

Question 12

What are the conditions for an individual practitioner to issue multiple prescriptions for a Schedule II controlled substance?

Answer 12

• Each prescription must be issued for a legitimate medical purpose by the practitioner acting in the usual course of professional practice.
• The practitioner must provide written instructions on each prescription (other than the first prescription, if it’s intended to be filled immediately) indicating the earliest date the pharmacy may fill each prescription.
• The practitioner must ensure that issuing multiple prescriptions does not create an undue risk of diversion or abuse.
• The issuance of multiple prescriptions must be permissible under applicable state laws.
• The practitioner must comply with all other requirements under the CSA and CFR, and any additional state laws.

Question 13

What should an individual practitioner consider when issuing multiple prescriptions for Schedule II controlled substances?

Answer 13

• The regulation should not be interpreted as encouraging practitioners to issue multiple prescriptions or to see patients only once every 90 days.
• Practitioners must use sound medical judgment and follow established medical standards to determine the appropriateness of issuing multiple prescriptions and the frequency of patient visits.

Question 14

Q: What are the requirements for the content and distribution of the notice regarding protected health information (PHI) by a covered entity?

Answer 14

1. Content Requirements:
   
   • Use and Disclosure: Describe how the covered entity may use and disclose protected health information about an individual.
   • Individual’s Rights: Outline the individual’s rights with respect to their information, including how to exercise these rights and how to complain to the covered entity.
   • Legal Duties: Include a statement on the covered entity’s legal duties, including the requirement to maintain the privacy of protected health information.
   • Contact Information: Provide details on whom individuals can contact for more information about the covered entity’s privacy policies.
   • Effective Date: The notice must include an effective date.
2. Revision and Distribution Requirements:
   
   • The covered entity must promptly revise and distribute the notice whenever it makes material changes to its privacy practices.

Question 15

Q: What are some of the required activities or clinical interventions under REMS (Risk Evaluation and Mitigation Strategies)?

Answer 15

1. Certification Requirements:
   
   • Prescribers and dispensers (e.g., pharmacists) may need to become certified in the REMS program and agree to perform specific activities to mitigate the risk of the drug.
2. Safe Use Conditions:
   
   • REMS may require documentation of a “safe use condition” (e.g., a monthly lab test) before the drug can be dispensed to the patient.
3. Ongoing Treatment Requirements:
   
   • Certain actions might be required for a patient to continue treatment with the medication.
4. Combination of Requirements:
   
   • REMS often use a combination of these requirements or activities to achieve their safety goals.

Question 16

What constitutes a breach under the Privacy Rule?

Answer 16

A breach is generally defined as an impermissible use or disclosure of protected health information that compromises the security or privacy of that information.

Question 17

What must a covered entity or business associate demonstrate to show that an impermissible use or disclosure is not a breach?

Answer 17

To demonstrate that there is a low probability that the protected health information has been compromised, the covered entity or business associate must perform a risk assessment considering:

• Nature and Extent: The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of re-identification.
• Unauthorized Person: The unauthorized person who used the information or to whom the disclosure was made.
• Acquisition or Viewing: Whether the information was actually acquired or viewed.
• Risk Mitigation: The extent to which the risk to the information has been mitigated.

Question 18

Do covered entities and business associates have to perform a risk assessment before providing breach notifications?

Answer 18

Covered entities and business associates have the discretion to provide breach notifications following an impermissible use or disclosure without performing a risk assessment to determine the probability that the protected health information has been compromised.

Question 19

What are the exceptions to the definition of a breach?

Answer 19

• Unintentional Acquisition: Unintentional acquisition, access, or use of protected health information by a workforce member or person acting under the authority of a covered entity or business associate, if done in good faith and within the scope of authority.
• Inadvertent Disclosure: Inadvertent disclosure of protected health information by a person authorized to access it to another person authorized to access it, within the same covered entity or business associate or organized health care arrangement, as long as the information is not further used or disclosed improperly.
• Good Faith Belief: If the covered entity or business associate has a good faith belief that the unauthorized person to whom the impermissible disclosure was made could not have retained the information.

Question 20

A schedule III controlled substance can be electronically transferred to another pharmacy

I. On a 1 time basis only

II. As long as it was received electronically

III. By pharmacy interns

Answer 20

I and II
.
The prescription must remain in its electronic form; may not be altered in any way; and the transfer must be communicated directly between two licensed pharmacists.

Question 21

Q: What defines therapeutic equivalents in drug products?

Answer 21

Approved drug products are considered therapeutic equivalents if:
1. Pharmaceutical Equivalence: They are pharmaceutical equivalents, meaning they contain the same active ingredient(s), dosage form, strength, and route of administration.
2. Bioequivalence: Bioequivalence has been demonstrated, meaning the products release the active ingredient into the bloodstream at the same rate and extent.
3. Clinical Effect and Safety: They can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

Question 22

What are the breach notification requirements for covered entities?

Answer 22

• Notify Affected Individuals: Provide individual notice in written form (by first-class mail or email if agreed upon) within 60 days of discovery. If contact information is insufficient for 10 or more individuals, provide substitute notice via website or media. Include a description of the breach, the types of information involved, steps for protection, investigation details, and contact information.
• Notify the Secretary: Submit a breach report form on the HHS website. For breaches affecting 500 or more individuals, notify within 60 days. For fewer than 500 individuals, report annually within 60 days after the end of the calendar year.
• Notify the Media: For breaches affecting more than 500 residents of a state or jurisdiction, notify prominent media outlets within 60 days, including the same information required for individual notices.

Question 23

What are the requirements for individual notice in the event of a breach?

Answer 23

• Method: Written notice by first-class mail or email (if agreed upon).
• Substitute Notice: If contact info is insufficient for 10 or more individuals, post notice on the website or provide it in major media. For fewer than 10, substitute notice by alternative written means, phone, or other methods.
• Timing: Must be provided without unreasonable delay and no later than 60 days following breach discovery.
• Content: Description of the breach, types of information involved, steps for protection, what is being done to investigate and mitigate harm, and contact information.

Question 24

Q: What must business associates do in the event of a breach?

Answer 24

• Notification to Covered Entity: Notify the covered entity without unreasonable delay and no later than 60 days from discovery.
• Information Provided: Provide identification of affected individuals and any other relevant information required by the covered entity for notification.

Question 25

What are the administrative requirements related to breach notification?

Answer 25

• Documentation: Maintain documentation proving that all required notifications were made or demonstrate why notification was not required (e.g., risk assessment or exceptions to the definition of “breach”).
• Policies and Procedures: Have written policies and procedures for breach notification.
• Training: Train employees on these policies and procedures.
• Sanctions: Apply appropriate sanctions against workforce members who do not comply.

Question 26

Q: What is de-identified health information and what are the methods for de-identifying it?

Answer 26

• Definition: De-identified health information neither identifies nor provides a reasonable basis to identify an individual. There are no restrictions on its use or disclosure.
• Methods for De-Identification:
  1. Formal Determination: A qualified statistician determines that the risk of identifying an individual is very small.
  2. Removal of Identifiers: All specified identifiers of the individual, their relatives, household members, and employers are removed. This method is adequate only if the covered entity has no actual knowledge that the remaining information could be used to identify the individual.

Question 27

Q: What are the general principles for the use and disclosure of protected health information under the Privacy Rule?

Answer 27

• Basic Principle:
  
  • A major purpose of the Privacy Rule is to define and limit when a covered entity can use or disclose an individual’s protected health information.
  • Permitted Uses and Disclosures: A covered entity may use or disclose protected health information only if:
    
    1. The Privacy Rule permits or requires it.
    2. The individual (or their personal representative) authorizes it in writing.
• Required Disclosures:
  
  1. To Individuals: Disclose protected health information to individuals (or their personal representatives) when they request access to or an accounting of disclosures of their information.
  2. To HHS: Disclose information to the Department of Health and Human Services (HHS) for compliance investigations, reviews, or enforcement actions.

Question 28

Q: What is a drug recall and how does the FDA oversee it?

Answer 28

Definition: A drug recall is a voluntary action taken by a company to remove a defective or potentially harmful drug product from the market. This can be done on the company’s initiative or at the FDA’s request.
FDA’s Role:
- Oversight: The FDA oversees the company’s recall strategy.
- Assessment: Assesses the adequacy of the recall.
- Classification: Classifies the recall into Class I, Class II, or Class III based on the level of hazard.

Question 29

Q: How is the public alerted about drug recalls?

Answer 29

• Public Notification: Issued for products widely distributed or posing a serious health hazard. If not issued by the company, the FDA may issue it if necessary.
• Alternative Notifications: Patients may learn of recalls through manufacturers, health care professionals, or pharmacists.
• Action for Recalled Medicine: Patients should consult their health care professional and may return the product to the store. Stores typically have return and refund policies for recalled products.

Question 30

Q: Where can you find information about drug recalls and their classifications?

Answer 30

FDA Enforcement Report: All recalls are posted weekly. Recalls are classified as Class I, Class II, or Class III based on the hazard level. Ongoing recalls that are not yet classified are listed as “not yet classified” until a classification is determined.

Question 31

Q: How does the FDA determine the effectiveness of a recall?

Answer 31

• Evaluation: The FDA evaluates the effectiveness of a recall by reviewing the company’s efforts to notify customers and remove the defective product from the market.
• Further Actions: If a recall is deemed ineffective, the FDA may request additional actions from the company.

Question 32

When selling pseudoephedrine over-the-counter to a patient without a prescription, the pharmacy is required to document (written or electronically) the (Select all that apply)

Choose ALL answers that apply.

A
Name of the purchaser

B
Social security number of the purchaser

C
Address of the purchaser

D
Date and time of the sale

E
Name and amount of product sold

Answer 32

ALL! EXCEPT B! No need for social

Question 33

Recall Classification
Class I:

Answer 33

A dangerous or defective product that could cause serious health problems or death.

Question 34

Recall Classification
Class II:

Answer 34

A product that might cause a temporary health problem, or pose slight threat of a serious nature.

Question 35

Recall Classification
Class III:

Answer 35

Class III: A products that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.

Question 36

Q: What are the strengths of VAERS data?

Answer 36

• Open Reporting: VAERS accepts reports from anyone, which helps detect rare adverse events.
• Comprehensive Data Collection: Collects information about the vaccine, the person vaccinated, and the adverse event. Follow-up information is obtained for serious reports.
• Public Availability: All data (excluding identifying patient information) are publicly available.

Question 37

What are the limitations of VAERS data?

Answer 37

• Passive Reporting System: Relies on individuals to file reports; not automatically collected.
• Report Quality Issues: Reports may lack details or contain errors since submissions are made by anyone.
• Causality Not Determined: VAERS data alone cannot determine if the vaccine caused the adverse event.
• Misinterpretation Risk: Reports of deaths following vaccination might be misinterpreted as vaccine-caused deaths.
• Coincidental Events: Some reports may represent unrelated adverse events.
• Increased Reporting Bias: Number of reports may increase due to media attention and public awareness.
• Inability to Calculate Rates: VAERS data cannot be used to determine how often an adverse event occurs in the population.

Question 38

Q: What is VAERS and how does it operate?

Answer 38

• Purpose: VAERS is a national vaccine safety surveillance program that helps detect unusual or unexpected reporting patterns of adverse events for vaccines.
• Surveillance System: It is a passive surveillance system, relying on voluntary reports.
• Reporters: Accepts reports from patients, family members, healthcare providers, and vaccine manufacturers.
• Legal Requirements: Healthcare providers and vaccine manufacturers are required by law to report certain adverse events.
• Not Causality Determination: VAERS does not determine if a vaccine caused or contributed to an adverse event.
• Follow-Up Studies: If VAERS detects a pattern of adverse events, further studies are conducted by other vaccine safety monitoring systems.

Question 39

How does REMS communicate important information to patients?

Answer 39

• Patient Materials: REMS may require drug manufacturers to develop materials for patients, such as Medication Guides.
• Medication Guides:
  
  • Purpose: Provide FDA-approved information in patient-friendly language.
  • Content: Help inform patients about proper medication use and how to avoid serious adverse events.
  • Distribution: Generally provided at the time the medication is dispensed or administered.
  • Approval: All Medication Guides are approved as part of a drug’s labeling, though only a subset is included in REMS.

Question 40

Q: What are the requirements for providing a Vaccine Information Statement (VIS) to patients?

Answer 40

• Requirement: Healthcare providers must provide a VIS before administering vaccines such as diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Hib, influenza, pneumococcal conjugate, meningococcal, rotavirus, HPV, and varicella.
• Recipients:
  To the parent or legal representative of any child receiving the vaccine.
  To any adult receiving the vaccine.

Question 41

VIS - What should be done if a combination vaccine is administered?

Answer 41

Combination Vaccines: If there is no single VIS for the combination vaccine, provide VISs for all individual component vaccines.

Question 42

Q: What additional information should accompany a VIS when it is provided?

Answer 42

Supplemental Information: VISs should be supplemented with visual presentations or oral explanations as appropriate to ensure understanding.

Question 43

Q: What are the recordkeeping requirements for providing a VIS?

Answer 43

For VIS Provision:
Record the edition date of the VIS distributed.
Record the date the VIS was provided.
.
For Vaccine Administration:
Record the name, address, and title of the individual who administered the vaccine.
Record the date of administration.
Record the vaccine manufacturer and lot number.

Question 44

You are a staff pharmacist at a community pharmacy and you’ve received an electronic prescription for a patient for a biologic. In order to check if there is an interchangeable biosimilar that you may substitute for the prescribed biologic, you must check the

Answer 44

Purple FDA book

Question 45

Q: What additional responsibilities do providers have regarding Vaccine Information Statements (VISs)?

Answer 45

Recording Information in Patient Records:
- The edition date of the VIS (found on the back at the right bottom corner).
- The date the VIS is provided (i.e., the date of the visit when the vaccine is administered).
- The office address and name and title of the person who administers the vaccine.
- The date the vaccine is administered.
- The vaccine manufacturer and lot number.

Question 46

Q: Can providers modify Vaccine Information Statements (VISs)?

Answer 46

• Modifications Allowed: Providers may add the name, address, and contact information of their practice to an existing VIS.
• Modifications Not Allowed: Providers may not make any substantive changes to the VIS.

Question 47

Q: What methods can providers use to ensure patients understand the Vaccine Information Statement (VIS)?

Answer 47

Methods to Enhance Understanding:
- Read the VIS to the patient.
- Provide a videotaped version of the VIS.
- Offer additional printed material.
- Help recipients understand the disease and vaccine in any other way.

Question 48

Q: What should providers always offer patients regarding the vaccine?

Answer 48

Opportunity for Questions: Providers should always offer the patient an opportunity to ask questions about the vaccine.

Question 49

Q: What are the responsibilities of Covered Direct Treatment Providers regarding providing the notice?

Answer 49

• General Requirement: Provide the notice to the individual no later than the date of first service delivery (after the April 14, 2003 compliance date of the Privacy Rule).
• Written Acknowledgment: Except in emergency situations, make a good faith effort to obtain the individual’s written acknowledgment of receipt of the notice. If not obtained, document the efforts and reasons.

Question 50

Q: What should Covered Direct Treatment Providers do when providing services electronically?

Answer 50

Electronic Notice: When service delivery is provided over the Internet, through email, or otherwise electronically, the provider must:
- Send an electronic notice automatically and contemporaneously in response to the individual’s first request for service.
- Make a good faith effort to obtain a return receipt or other transmission confirmation from the individual.

Question 51

Q: What are the requirements for providing the notice in an emergency treatment situation?

Answer 51

• Emergency Situations: Provide the notice as soon as reasonably practicable after the emergency situation ends.
• Acknowledgment: Providers are not required to make a good faith effort to obtain a written acknowledgment from individuals in emergency situations.

Question 52

Q: How should the latest notice be made available at the provider’s office or facility?

Answer 52

Availability of Latest Notice:
- Make the latest notice available for individuals to request and take with them.
- Post the notice in a clear and prominent location at the facility.

Question 53

Q: Is there a requirement to verify that parents/legal representatives have actually received and reviewed the VIS?

Answer 53

A: Yes. The mandatory instructions for use of the VIS require providers to make a notation in the patient’s medical record or permanent office log regarding provision of the VIS. If VISs (paper or electronic) are not provided to parents/legal representatives at the time of vaccination, parents/legal representatives must acknowledge in writing (or electronically) receipt and review of the current VIS. This can be accomplished by including a written statement that the parent/legal representative received and reviewed the current edition of the VIS, with the edition date specified, on the medical consent form authorizing vaccination. The parent’s/legal representative’s signature (or electronic signature if allowed under state law) then verifies receipt/review. Where allowed under the applicable state medical consent law, such verification/consent can be accomplished through electronic means. The signed verification of receipt/review of the VIS must be retained by the clinic/health care provider in the same manner and for the same timeframe as other medical consents are required to be retained by health care providers under the state’s medical consent law.

Question 54

Q: What is Protected Health Information (PHI) under the Privacy Rule?

Answer 54

A: Protected Health Information (PHI) is “individually identifiable health information” held or transmitted by a covered entity or its business associate, in any form or media (electronic, paper, or oral). It includes information related to:
- The individual’s past, present, or future physical or mental health or condition.
- The provision of health care to the individual.
- The past, present, or future payment for health care.
And it identifies the individual or has a reasonable basis to believe it can be used to identify the individual. Common identifiers include name, address, birth date, and Social Security Number.

Question 55

Q: What information is excluded from PHI under the Privacy Rule?

Answer 55

A: The Privacy Rule excludes:
- Employment records maintained by a covered entity in its capacity as an employer.
- Education records and certain other records defined by the Family Educational Rights and Privacy Act (FERPA), 20 U.S.C. §1232g.

Question 56

Q: What is de-identified health information and how is it protected?

Answer 56

A: De-identified health information neither identifies nor provides a reasonable basis to identify an individual. There are two methods for de-identification:
1. Formal Determination: A qualified statistician makes a formal determination that the information is de-identified.
2. Removal of Identifiers: The specified identifiers of the individual and their relatives, household members, and employers are removed. This method is adequate only if the covered entity has no actual knowledge that the remaining information could be used to identify the individual.

Question 57

Q: Are there restrictions on the use or disclosure of de-identified health information?

Answer 57

A: No, there are no restrictions on the use or disclosure of de-identified health information.

Question 58

What are the acceptable methods for providing the Vaccine Information Statement (VIS) to parents/legal representatives?

Answer 58

The VIS must be provided in the following ways:

1. In-Person: Provide a physical or electronic copy of the VIS directly to the parent/legal representative before the child is vaccinated.
2. If Not Present at Vaccination: The VIS must be sent before vaccination and should include a method to verify receipt and review. Methods include:
   
   • Providing a physical copy of the VIS.
   • Sending a link to the VIS in a physical letter.
   • Attaching the VIS or providing a weblink in an email.

Additionally, if the VIS is not provided at the time of vaccination, the parent/legal representative must acknowledge receipt and review of the VIS, typically by including a statement on the medical consent form. This acknowledgment can be done electronically if allowed by state law.

Question 59

Ways to give a VIS

Answer 59

• Paper copies of the VIS can be printed and given to patients prior to vaccination.
• Permanent, laminated office copies may be given to patients to read prior to vaccination.
• Patients may view VISs on a computer monitor or other video display.
• Patients may read the VIS on their phone or other digital device by downloading the pdf file from CDC’s website.
• Patients may be given a copy of a VIS during a prior visit, or told how to access it through the internet, so they can read it in advance. These patients must still be offered a copy to read during the immunization visit, as a reminder.
• Patients must still be offered a copy of the VIS to take away following the vaccination. The patient may decline.

Question 60

Which of the following must be the very first (top) item to appear on the label of an Over-The-Counter drug label?

Choose only ONE best answer.

A
The product’s active ingredients

B
The purpose of the product

C
The use for the product

D
Warnings

E
Dosage

F
Inactive ingredients

Answer 60

A - active ingredient!
.
The following information must appear in this order:

*The product’s active ingredients, including the amount in each dosage unit.
*The purpose of the product.
*The uses (indications) for the product.
*Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid.
*Dosage instructions–when, how, and how often to take the product.
*The product’s inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction.

Question 61

A pharmacy that is selling, loaning, or transferring a Schedule II drug to another DEA-registered pharmacy must complete DEA form _____________

Answer 61

222

Question 62

Question: Does the CSA or DEA regulations prohibit DEA-registered practitioners or mid-level practitioners from issuing controlled substance prescriptions for personal use of the prescriber, friends, or family members?

Answer 62

Answer: No. However, practitioners and mid-level practitioners should be aware when prescribing controlled substances for personal use of the prescriber, friends, and family members, that the CSA and DEA regulations require that a prescription for a controlled substance be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription that is not issued for a legitimate medical purpose in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of 21 U.S.C. 829. The person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. 21 U.S.C. 841(a)(1) and 21 CFR 1306.04(a). Further, a prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purposes of general dispensing to patients. 21 CFR 1306.04(b). In addition, prescribing practitioners and mid-level practitioners must comply with applicable State, Federal, and local laws which may prohibit such activity. 21 U.S.C. 823(f)(4). The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or Department of Justice policies. EO-DEA099, October 4, 2022

Question 63

What does dispensing a REMS medication entail?

Answer 63

Many REMS do not require pharmacists to do anything outside of their normal dispensing activities. However, for certain REMS, pharmacists and other dispensers may need to complete training, verify safe use conditions (e.g., verifying required laboratory monitoring or that a patient or health care provider is enrolled in the REMS), counsel patients, and/or provide the patient with educational materials or a Medication Guide prior to dispensing a medication with a REMS. Not every program will require these steps, so it is important to check the REMS@FDA website or the manufacturer’s REMS website for a complete list of requirements for the specific medication to be dispensed.

Question 64

Do I, or does my healthcare setting or pharmacy, have to enroll in a certain program?

Answer 64

Some REMS require that a pharmacy or healthcare setting be certified to be able to receive or dispense the medication. To fulfill this requirement, the pharmacy or health care setting may identify an authorized representative to enroll on behalf of the pharmacy or setting. However, in some cases, every pharmacist who dispenses the medication may be required to complete training to meet this requirement. Individual pharmacists or pharmacy staff may also be required to enroll to obtain authorization to dispense. Not every program will require these steps, so it is important to check the REMS@FDA website or the manufacturer’s REMS website for a complete list of requirements for the specific medication to be dispensed.

Question 65

Does the patient have to be enrolled in a certain program?

Answer 65

Some REMS require the patient to be enrolled. In most cases, health care providers enroll patients. The pharmacist may need to verify that the patient is enrolled before dispensing the medication. Depending on the program, this may require a phone call to the REMS call center, verification through the specific product REMS website, or verification that is built into the pharmacy management system.

Question 66

Is there monitoring involved with medications that are under a REMS?

Answer 66

Some REMS medications do require documentation of specific lab test results or some other form of patient monitoring. In the case of a drug that requires specific lab test results or some other type of monitoring prior to dispensing, the pharmacist is responsible for verifying that the lab test or other monitoring tests have been completed before filling or refilling a medication. Depending on the program, verification of the specific requirement may require a phone call to the REMS call center, verification through the specific product REMS website, or verification that is built into the pharmacy management system. If the information cannot be verified, the pharmacist may need to contact a health care provider’s office to ensure the lab test or other monitoring requirement was ordered or conducted.

Question 67

REMS- I understand pharmacists may have to verify safe use conditions. How is that done?

Answer 67

Pharmacists play a key role in REMS as the last checkpoint before patients receive their medication. In many REMS with participant requirements, pharmacists are asked to go to a website or a contact a call center to verify that certain safe use conditions are in place prior to dispensing. For example, pharmacists may need to confirm that the prescriber or patient is enrolled or the patient has undergone laboratory monitoring. Certain programs verify safe use conditions directly through the pharmacy management system using an electronic verification system, sometimes referred to as a “switch.”

Question 68

REMS - Am I required to complete training?

Answer 68

Some REMS have required training for pharmacists which may include passing a knowledge assessment test. For most REMS, the authorized pharmacy representative is required to take the initial training that is part of the certification process for pharmacies and to make sure all pharmacists are trained. Information about training or any other requirements can be found at REMS@FDA, in product labeling, or on REMS-specific websites.

Question 69

REMS - Are there restrictions on the amount of medication that can be dispensed?

Answer 69

Some REMS medications have additional restrictions on the number of refills allowed or the days supply dispensed. For example, a medication with a risk of teratogenicity (ability to cause birth defects) may be limited to a one-month supply at a time and may not be refilled unless certain criteria are met, such as verification of a negative pregnancy test.

Question 70

Question: Can I send electronic controlled substance prescriptions to a pharmacy via e-mail?

Answer 70

Answer: No. “An electronic prescription”—that is, “a prescription that is generated on an electronic application and transmitted as an electronic data file”—must “be created and signed using an application that meets the requirements of part 1311 of this chapter.” 21 CFR 1300.03, 1306.05(e). These requirements include, among other things, an audit or certification to ensure that the application “records, stores, and transmits” the necessary information “accurately and consistently,” the capability to “[l]ink each registrant, by name to at least one DEA registration number,” logical access controls “set by individual user name or role” that limit permissions for “signing controlled substance prescriptions,” the ability to “accept two-factor authentication,” and digital signature functionality that satisfies the relevant Federal Information Processing Standards (FIPS) developed by the National Institute of Standards and Technology.

Question 71

Question: May a prescription be issued in order for a practitioner to obtain controlled substances for dispensing to patients?

Answer 71

Answer: No. See 21 CFR 1306.04(b), “A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

Question 72

Question: What should be done with unused DEA 222 Order Forms if a business closes?

Answer 72

Answer: When a registered purchaser discontinues business activities involving schedule I and II controlled substances for any reason (i.e. discontinues business or professional practice altogether, ceases legal existence, or if the registered purchaser dies), all unexecuted DEA 222 order forms must be promptly returned to DEA Headquarters Registration Section. See 21 CFR 1301.52, 1305.18 and 1305.20(h). Similarly, a purchaser must immediately return all unused 222 forms if its registration for schedule I and II controlled substances is suspended or revoked under 21 CFR 1301.36. EO-DEA190, October 5, 2020

Question 73

Two different drug products labeled with Therapeutic Equivalence (TE) codes of (Select all that apply)

Choose ALL answers that apply.

A
AB and AB are considered therapeutically equivalent

B
AB1 and AB2 are considered therapeutically equivalent

C
AB1 and AB1 are considered therapeutically equivalent

D
AB3 and AB3 are considered therapeutically equivalent

E
A and B are considered therapeutically equivalent

Answer 73

A,C,D
.
Even though drug products of distributors and/or repackagers are not included in the Orange Book, they are considered therapeutically equivalent to the applicant’s drug product if the applicant’s drug product is rated either with an AB or three-character code or is single source in the Orange Book. Drugs coded as AB under a heading are considered therapeutically equivalent only to other drugs coded as AB under that heading. Drugs coded with a three-character code under a heading are considered therapeutically equivalent only to other drugs coded with the same three-character code under that heading.

Question 74

Q: How do electronic DEA 222 Order Forms work and what is required to use them?

Answer 74

A: The DEA Controlled Substance Ordering System (CSOS) enables secure electronic ordering of Schedule II controlled substances, eliminating the need for paper DEA Order Form 222. Here’s how it works:

1. Optional Use: Registrants can choose to use CSOS or continue using paper forms.
2. Requirements:
   
   • Digital Certificate: Users must obtain a CSOS digital certificate, which is signed with a digital signature issued by the DEA’s Certification Authority (CA).
   • Certification Authority: Only individuals authorized by DEA can obtain a digital certificate. This includes the person who signed the most recent DEA registration, authorized signatories, or those with power of attorney.
   • CSOS Coordinator: Registrants must appoint a CSOS coordinator to handle issues related to digital certificates.
   • Validity and Revocation: Digital certificates remain valid until the DEA registration expires or if the certificate needs revocation due to changes in authorization, compromised information, or loss.

CSOS uses Public Key Infrastructure (PKI) technology to ensure secure and valid electronic transactions.

Question 75

What is the difference between a biosimilar and an interchangeable biosimilar?

Answer 75

All FDA-approved biosimilars, including interchangeable biosimilars, must be highly similar to and have no clinically meaningful differences from the reference product in terms of safety and effectiveness. An interchangeable biosimilar is a biosimilar that meets additional requirements. A pharmacist may substitute an interchangeable biosimilar for its reference product without consulting the prescriber, depending on state pharmacy laws. FDA does not evaluate or approve a biosimilar as interchangeable unless a company requests it. Learn more about interchangeable biological products.

Question 76

Question: What is a Significant Loss or Theft?

Answer 76

Answer: When determining whether a loss is significant, a registrant should consider, among others, the following factors:
1.The actual quantity of controlled substances lost in relation to the type of business;
2.The specific controlled substances lost;
3.Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
4.A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
5.Whether the specific controlled substances are likely candidates for diversion;
6.Local trends and other indicators of the diversion potential of the missing controlled substance 21 CFR 1301.74(c) and 1301.76(b).

Question 77

A prescription transfer

I. For a schedule II controlled substance must be done electronically, and only if the prescription was also issued electronically initially

II. For a controlled substance must be communicated directly between two licensed pharmacists

III. For a schedule IV controlled substance may be electronically transferred between distinct pharmacies up to a maximum of 5 times

Answer 77

I and II
.
Under the final rule, a prescription can only be transferred once between pharmacies, and only if allowed under existing state or other applicable law. The prescription must remain in its electronic form; may not be altered in any way; and the transfer must be communicated directly between two licensed pharmacists. It’s important to note, any authorized refills transfer with the original prescription, which means the entire prescription will be filled at the same pharmacy.

Question 78

DEA Form 106

Answer 78

To Report theft or significant loss of CS

Question 79

DEA Form 41

Answer 79

To record CS destruction

Question 80

DEA Form 222

Answer 80

For ordering/transferring C-IIs

Question 81

DEA Form 224

Answer 81

For a pharmacy’s registration with DEA to be authorized to obtain and dispense CS

Question 82

Controlled substance inventory

I. Records must be maintained at least 5 years

II. Must be taken at least every 2 years

III. Of schedule II controlled substances must be taken by actual physical count

Answer 82

II and III
.
The CSA also requires that all inventory records be maintained at the registered location for at least two years (not 5) for copying and inspection. Inventories of schedule II controlled substances will be determined by an actual physical count.

After the initial inventory, the registrant is required to take a new inventory at least every two years, which requires the same information as the initial inventory of all controlled substances on hand.

Question 83

Adalat CC and Procardia XL are both extended release tablets for nifedipine. These drug products have been assigned Therapeutic Equivalence (TE) codes of AB1 and AB2, respectively. These two products are (Select all that apply)

Choose ALL answers that apply.

A
Therapeutically equivalent

B
Bioequivalent

C
Pharmaceutically equivalent

Answer 83

C ONLY!
.
For example, Adalat® CC and Procardia XL®, extended-release tablets, are listed under the active ingredient nifedipine. These drug products, listed under the same heading, are not bioequivalent to each other. Adalat® CC and Procardia XL® have been assigned ratings of AB1 and AB2, respectively. (oragne book)

Question 84

What are the regulations for filling Schedule II controlled substance prescriptions?

Answer 84

• Time Limit: There is no federal time limit for filling a Schedule II prescription after it has been signed by the practitioner. However, pharmacists must assess whether the prescription is still needed by the patient at the time of filling.
• Quantity Limits: Federal regulations do not specify quantity limits for Schedule II prescriptions. The prescription must be for a legitimate medical purpose, issued by a practitioner acting within the usual course of professional practice.

Question 85

Q: What are the rules for transferring prescriptions between pharmacies under the final rule?

Answer 85

1. One-Time Transfer: A prescription can be transferred only once between pharmacies.
2. State Law Compliance: The transfer must be allowed under state or other applicable laws.
3. Electronic Form: The prescription must remain in its original electronic form and cannot be altered.
4. Communication: The transfer must be communicated directly between two licensed pharmacists.
5. Authorized Refills: Any authorized refills are transferred with the original prescription, meaning the entire prescription, including refills, will be filled at the receiving pharmacy.

Question 86

You are a staff pharmacist at a retail pharmacy and you receive a prescription for amphetamine/dextroamphetamine salts 10mg, issued for a quantity of 365, take 1 tablet PO daily. This prescription

I. Is invalid, as it may not be filled for 365

II. Is invalid, and should be reported to the Board of Medicine

III. Is valid, if all other prescription requirements are met

Answer 86

III only!
.
there is no federal limit on quantity or day supply. However, many states have quantity/day supply limits related to opioids in particular, which obviously amphetamine/dextroamphetamine is not. We recommend that you double-check your state law on this topic.

Question 87

Q: What are the labeling and prescription rules for controlled substances under federal regulations?

Answer 87

1. Labeling Warning:
   
   • Regulation: 21 CFR 290.5.
   • Requirement: The label of any controlled substance in schedules II, III, or IV must include the warning: “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
2. Partial Filling of Schedule II Prescriptions:
   
   • Amendment: CARA Section 702 added to 21 U.S.C. 829(f).
   • Provision: Allows a prescription for a controlled substance in Schedule II to be partially filled at the request of the patient or prescribing practitioner.
3. Validity of Schedule II Prescriptions for LTCF or Terminally Ill Patients:
   
   • Rule: Schedule II prescriptions for patients in long-term care facilities (LTCF) or terminally ill patients are valid for up to 60 days from the issue date.
   • Condition: The prescription is valid for this period unless discontinued sooner.

Question 88

Emergency Oral Schedule II Prescriptions - what must be done

Answer 88

1. The drug prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period.
2. The prescription order must be immediately reduced to writing by the pharmacist and must contain all required information, except for the prescribing practitioner’s signature.
3. Within seven days after authorizing an emergency oral prescription, the prescribing practitioner must furnish the pharmacist a written, signed prescription for the emergency quantity of the controlled substance prescribed.

Question 89

Breakage or spillage of any controlled substances that are non-recoverable must be

I. Recorded on DEA form 106

II. Documented & signed by two individuals who can testify that the break/spill occurred

III. Require that the pharmacy notify DEA

Answer 89

II only
.
These types of incidents do not require notification to DEA.

It is DEA’s position that in order to maintain complete and accurate records that non-recoverable breakage or spillage must be recorded on a DEA Form 41 and, as with any other form of disposal under 21 CFR Part 1317, should be signed by two individuals who can testify that a breakage or spillage occurred. These records must be maintained in the registrant’s files and contain such information.

Question 90

Central Fill pharmacies

I. Must affix a label to the dispensed vial with an indicator that it was filled at the central fill pharmacy

II. Must keep records of all prescriptions it filled

III. May not fill schedule II controlled substances

Answer 90

I and II

Question 91

Without being registered as a distributor, a retail pharmacy may distribute up to ____ of its total dosage units of controlled substances dispensed in the calendar year to another pharmacy as needed

Answer 91

5%
.
4. “Five Percent Rule” – The total number of dosage units of all controlled substances distributed by a pharmacy may not exceed five percent of the total number of dosage units of all controlled substances dispensed by the pharmacy during a calendar year. If at any time during the calendar year the total number of dosage units of controlled substances distributed exceed five percent of the total number of dosage units of controlled substances distributed and dispensed, the pharmacy is required to register as a distributor.