Guideline/Drug Updates and Errata
RxPrep content (e.g., NAPLEX Course Book, MPJE/CPJE Manuals and QBanks) is up-to-date at the time of publishing, but drug information and laws can change at any time. If information changes after a product is published, we will post exam-relevant updates in the Guideline/Drug Updates tables below. If we find anything that needs a correction or clarification it will be included in the Errata tables below.
Updates: 2023 UWorld RxPrep Course Book
NAPLEX-relevant guideline and drug updates from June 2022-May 2023
Page | Update Type | Description |
---|---|---|
Chapters 15-17: Compounding I, II, and III | ||
p. 226-281 | Guideline Update | Revised United States Pharmacopeia (USP) chapters 795 (Nonsterile Preparations)
and 797 (Sterile Preparations) were published on November 1, 2022, and the changes will become official on
November 1, 2023. Since the changes will not be official until November 1, 2023, these updates are unlikely to
have an immediate impact on the compounding content tested on the NAPLEX. USP 795 USP 797 |
Chapter 31: Chronic Heart Failure and Chapter 44: Diabetes | ||
p. 466-469, 471 | Guideline Update | The American Heart Association (AHA) and American College of Cardiology (ACC)
released the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors and aldosterone receptor antagonists are now considered initial medications for all patients with heart failure with reduced ejection fraction (HFrEF) without contraindications. 2022 AHA/ACC Heart Failure Guidelines |
Chapter 42: Chronic Obstructive Pulmonary Disease | ||
p. 590-591 | Guideline Update | The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released the
2023 guidelines for COPD diagnosis, management, and prevention. Key changes that could impact testing include:
|
Chapter 44: Diabetes | ||
p. 607-608 | Guideline Update | The 2023 American Diabetes Association (ADA) Standards of Care update was published. Key changes that could impact testing include: p. 607: Comprehensive Care, section on Cholesterol Control
p. 607: Comprehensive Care, section on Diabetic Kidney Disease
p. 607: Comprehensive Care, section on Blood Pressure Control
p. 608: Treatment for Type 2 Diabetes and Treatment Algorithm
|
Errata: 2023 UWorld RxPrep Course Book
Corrections or clarifications for the 2023 RxPrep Course Book
Page | Description | |
---|---|---|
Chapter 27: Dyslipidemia | ||
p. 426 | In the Statin Treatment Intensity Definitions and Selection Options table, pitavastain doses of 1-4 mg are considered moderate intensity. |
Updates: 2024 UWorld RxPrep Course Book
NAPLEX-relevant guideline and drug updates from June 2023 – May 2024
Page | Update Type | Description |
---|---|---|
Chapter 47: Contraception & Infertility | ||
p. 652–654 | New Drug | The FDA has approved norgestrel 0.075 mg (Opill) as the first nonprescription (OTC) oral contraceptive. Opill is a progestin-only pill that should be taken once daily at the same time every day. |
Updates: 2023 UWorld RxPrep Course Book
NAPLEX-relevant guideline and drug updates from June 2022-May 2023
Chapters 15-17: Compounding I, II, and III |
||
Page p. 226-281 |
Update type Guideline Update |
|
Revised United States Pharmacopeia (USP) chapters 795 (Nonsterile Preparations) and 797 (Sterile Preparations) were published on November 1, 2022, and the changes will become official on November 1, 2023. Since the changes will not be official until November 1, 2023, these updates are unlikely to have an immediate impact on the compounding content tested on the NAPLEX. USP 795 USP 797 |
||
Chapter 31: Chronic Heart Failure and Chapter 44: Diabetes |
||
Page p. 466-469, 471 |
Update type Guideline Update |
|
The American Heart Association (AHA) and American College of Cardiology (ACC) released the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors and aldosterone receptor antagonists are now considered initial medications for all patients with heart failure with reduced ejection fraction (HFrEF) without contraindications. 2022 AHA/ACC Heart Failure Guidelines |
||
Chapter 42: Chronic Obstructive Pulmonary Disease | ||
Page p. 590-591 |
Update type Guideline Update |
|
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released the 2023 guidelines for COPD diagnosis, management, and prevention. Key changes that could impact testing include: The combined assessment of COPD has been changed from an ABCD system to an ABE system, where the previous groups of C and D are combined into one new group (E). Any patient with elevated risk of exacerbations is included in group E. The recommendations for initial pharmacologic therapy have been modified to match the new ABE system. Initial treatment by group includes:
|
||
Chapter 44: Diabetes | ||
Page p. 607-608 |
Update type Guideline Update |
|
The 2023 American Diabetes Association (ADA) Standards of Care update was published. Key changes that could impact testing include: p. 607: Comprehensive Care, section on Cholesterol Control Goal LDL targets are now:
p. 607: Comprehensive Care, section on Diabetic Kidney Disease
|
Errata: 2023 UWorld RxPrep Course Book
Corrections or clarifications for the 2023 RxPrep Course Book
Chapter 27: Dyslipidemia | ||
Page p. 426 |
||
In the Statin Treatment Intensity Definitions and Selection Options table, pitavastain doses of 1-4 mg are considered moderate intensity. |
Updates: 2024 UWorld RxPrep Course Book
NAPLEX-relevant guideline and drug updates from June 2023 – May 2024
Chapter 47: Contraception & Infertility | ||
Page p. 652–654 |
Update Type New Drug |
|
The FDA has approved norgestrel 0.075 mg (Opill) as the first nonprescription (OTC) oral contraceptive. Opill is a progestin-only pill that should be taken once daily at the same time every day. |
MPJE Updates: 7th Edition Federal Law Summary for MPJE
MPJE-relevant updates from January 2021–Present
Page | Update Type | Description |
---|---|---|
Chapter 3: Pharmacy Operations | ||
p. 44 | DEA Update
Effective October 2020 |
All controlled substances (schedule II – V) can be stored in a locked cabinet or
dispersed among other drugs. Prior to this change, schedule II drugs needed to be stored in a securely locked
cabinet or vault and could not be dispersed throughout the stock of non-controlled drugs.
2020 DEA Pharmacist’s Manual |
Chapter 4: Pharmacy Practice | ||
p. 77 | Interchangeable Biosimilar Approval
Effective July 2021 |
The following update impacts the last sentence in the section under Biologics and Biosimilars.
The FDA approved two interchangeable biosimilar products in 2021. The following are interchangeable:
|
Chapter 8: Controlled Substance Part 3: Prescribing and Dispensing | ||
p. 137, 154 -155 | Law Update
Effective June 2023 |
The following update impacts these sections:
On December 29, 2022, Congress eliminated the “DATA-Waiver Program” in order to increase access to buprenorphine and introduced new training requirements for all prescribers.
DEA Informational Document |
Chapter 3: Pharmacy Operations | ||
Page p. 44 |
Update type DEA Update Effective October 2020 |
|
All controlled substances (schedule II – V) can be stored in a locked cabinet or dispersed among other drugs. Prior to this change, schedule II drugs needed to be stored in a securely locked cabinet or vault and could not be dispersed throughout the stock of non-controlled drugs.
2020 DEA Pharmacist’s Manual |
||
Chapter 4: Pharmacy Practice | ||
Page p. 77 |
Update type Interchangeable Biosimilar Approval Effective July 2021 |
|
The following update impacts the last sentence in the section under Biologics and Biosimilars.
The FDA has now approved interchangeable biosimilar products. For example, the following are deemed interchangeable:
|
Chapter 8: Controlled Substance Part 3: Prescribing and Dispensing | ||
Page p. 137, 154 -155 |
Law Update
Effective June 2023 |
|
The following update impacts these sections:
On December 29, 2022, Congress eliminated the “DATA-Waiver Program” in order to increase access to buprenorphine and introduced new training requirements for all prescribers.
DEA Informational Document |
MPJE Errata: 7th Edition Federal Law Summary for MPJE
Corrections or clarifications for the 7th Edition Federal Law Summary for MPJE
Page | Description | |
---|---|---|
Chapter 4: Pharmacy Practice | ||
p. 65 | Regarding the prescription drugs that do not require child-resistant packaging, colesevelam powder should read ≤ 3.75 grams/package. | |
Chapter 8: Controlled Substances Part 3: Prescribing and Dispensing | ||
p. 154 | The 4th bullet in the Methadone Study Tip should read “(days 271 – 365).” |
Chapter 4: Pharmacy Practice | ||
Page p. 65 |
||
Regarding the prescription drugs that do not require child-resistant packaging, colesevelam powder should read ≤ 3.75 grams/package. | ||
Chapter 8: Controlled Substances Part 3: Prescribing and Dispensing | ||
Page p. 154 |
||
The 4th bullet in the Methadone Study Tip should read “(days 271 – 365).” |
CPJE Updates: 7th Edition California Law Summary for CPJE
CPJE-relevant updates from January 2021–Present
Page | Update Type | Description |
---|---|---|
Chapter 3: Pharmacy Practice Part I | ||
p. 52 | Interchangeable Biosimilar Approval Effective July 2021 |
The following update impacts the last sentence of the second paragraph under the Substituting Biologics section.
The FDA has now approved interchangeable biosimilar products. The approval allows for the substitution of approved biosimilars without the need for a separate prescription. For example, the following are deemed interchangeable:
|
Chapter 5: Controlled Substances Part 1: The Controlled Substances Act | ||
p. 96,98 | Law Update
Effective October 2021 |
California will now defer to the federal controlled substances scheduling rules and exemptions for barbituric acid (i.e., butalbital) and combinations with non-narcotics (e.g., acetaminophen). For example, Fioricet is no longer classified as schedule III in California.
The update above impacts the following:
|
Chapter 6: Controlled Substances Part 2: Ordering and Disposal | ||
p. 110 | Law Update
Effective April 2022 |
The following update impacts the Study Tip “Considerations to Determine if Loss or Theft is Significant.” The California Board of Pharmacy now defines the following as reportable significant loss of controlled substances:
|
Chapter 7: Controlled Substances Part 3: Prescribing and Dispensing | ||
p. 120 & 121 | Revised California Security Forms
Effective January 1, 2021 |
The following updates were made to secure prescription form requirements:
Joint Statement Regarding Secure Prescription Forms 11/2020 |
p. 124 | Law Update
Effective January 2022 |
As of January 1, 2022, exceptions to the mandatory electronic prescribing (e-prescribing) law include:
|
p. 117, 131 – 132 | Law Update
Effective June 2023 |
The following update impacts these sections:
On December 29, 2022, Congress eliminated the “DATA-Waiver Program” in order to increase access to buprenorphine and introduced new training requirements for all prescribers.
|
Chapter 3: Pharmacy Practice Part I | ||
Page p. 52 |
Update Type Interchangeable Biosimilar Approval Effective July 2021 |
|
The following update impacts the last sentence of the second paragraph under the Substituting Biologics section.
The FDA has now approved interchangeable biosimilar products. The approval allows for the substitution of approved biosimilars without the need for a separate prescription. For example, the following are deemed interchangeable:
|
||
Chapter 5: Controlled Substances Part 1: The Controlled Substances Act | ||
Page p. 96,98 |
Update Type Law Update Effective October 2021 |
|
California will now defer to the federal controlled substances scheduling rules and exemptions for barbituric acid (i.e., butalbital) and combinations with non-narcotics (e.g., acetaminophen). For example, Fioricet is no longer classified as schedule III in California.
The update above impacts the following:
|
||
Chapter 6: Controlled Substances Part 2: Ordering and Disposal | ||
Page p. 110 |
Update Type Law Update Effective April 2022 |
|
The following update impacts the Study Tip “Considerations to Determine if Loss or Theft is Significant.” The California Board of Pharmacy now defines the following as reportable significant loss of controlled substances:
|
||
Chapter 7: Controlled Substances Part 3: Prescribing and Dispensing | ||
Page p. 120 & 121 |
Update Type Revised California Security Forms Effective January 1, 2021 |
|
The following updates were made to secure prescription form requirements:
Joint Statement Regarding Secure Prescription Forms 11/2020 |
||
Page p. 124 |
Update Type Law Update Effective January 2022 |
|
As of January 1, 2022, exceptions to the mandatory electronic prescribing (e-prescribing) law include:
|
||
Page p. 117, 131 – 132 |
Update Type Law Update Effective June 2023 |
|
The following update impacts these sections:
On December 29, 2022, Congress eliminated the “DATA-Waiver Program” in order to increase access to buprenorphine and introduced new training requirements for all prescribers.
|
CPJE Errata: 7th Edition California Law Summary for CPJE
Corrections or clarifications for the 7th Edition California Law Summary for CPJE
Page | Description | |
---|---|---|
Chapter 2: Pharmacy Operations | ||
p. 24 | The last paragraph on the page should read: A pharmacy must contact the recipient (i.e., pharmacy, prescriber or patient) and board within 12 hours of the recall notice. An outsourcing facility must contact the recipient (i.e., pharmacy, prescriber or patient) and the board within 24 hours of the recall notice.
B&PC 4126.9, 4127.2, 4129.1 |
|
Chapter 7: Controlled Substances Part 3: Prescribing and Dispensing | ||
p. 121 | Under the second bullet that states “Six quantity check-off boxes,” the second sub-bullet should read “May be checked by the prescriber to correspond to the written quantity of the drug.”
H&SC 11162.1 |
Chapter 2: Pharmacy Operations | ||
Page p. 24 |
||
The last paragraph on the page should read: A pharmacy must contact the recipient (i.e., pharmacy, prescriber or patient) and board within 12 hours of the recall notice. An outsourcing facility must contact the recipient (i.e., pharmacy, prescriber or patient) and the board within 24 hours of the recall notice.
B&PC 4126.9, 4127.2, 4129.1 |
||
Chapter 7: Controlled Substances Part 3: Prescribing and Dispensing | ||
Page p. 121 |
||
Under the second bullet that states “Six quantity check-off boxes,” the second sub-bullet should read “May be checked by the prescriber to correspond to the written quantity of the drug.”
H&SC 11162.1 |