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.

NAPLEX

2023 2022

Updates: 2023 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: 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: Group A: a bronchodilator (SABA PRN, SAMA PRN, LABA or LAMA) Group B: dual therapy (LABA + LAMA) Group E: dual therapy (LABA + LAMA) or triple therapy (LABA + LAMA + ICS) if blood eosinophils are ≥ 300 µ/L The exacerbation pathway of the Escalation of Treatment algorithm has changed. If a patient has high eosinophils (≥ 300 µ/L), escalate to triple therapy (LABA + LAMA + ICS). Dual therapy with LABA + ICS is no longer recommended. If eosinophils are < 300 µ/L, escalate to dual bronchodilator therapy (LABA + LAMA). If further escalation is needed for patients on dual bronchodilator therapy, an ICS can be considered if eosinophils are ≥ 100 µ/L. There continues to be no role (no proven benefit) of ICS if eosinophils are < 100 µ/L. Adding on roflumilast or azithromycin can still be considered as a final step, regardless of eosinophil counts. 2023 GOLD COPD Guidelines
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 Goal LDL targets are now: < 55 mg/dL for patients with ASCVD. < 70 mg/dL for patients with high ASCVD risk. If these goals are not met with a high-intensity statin (or maximally tolerated dose), add-on agents (ezetimibe or PCSK9 inhibitor) are recommended. p. 607: Comprehensive Care, section on Diabetic Kidney Disease SGLT2 inhibitors are now recommended in patients with an eGFR ≥ 20 mL/min/1.73 m² to reduce CKD progression and cardiovascular events. Finerenone is recommended in patients with CKD + albuminuria (in addition to maximum tolerated doses of an ACE inhibitor or ARB and an SGLT2 inhibitor). p. 607: Comprehensive Care, section on Blood Pressure Control Goal blood pressure is now < 130/80 mmHg for all patients. p. 608: Treatment for Type 2 Diabetes and Treatment Algorithm GLP-1 agonists and SGLT2 inhibitors are first-line for cardiorenal comorbidities, with or without metformin (i.e., metformin does not need to be the first drug selected). Tirzepatide (Mounjaro), a GLP-1/GIP agonst, was added as a treatment option. It has high efficacy for both glycemic control and weight loss. 2023 ADA Guidelines

Errata: 2023 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.

Guideline/Drug Updates: 2022 UWorld RxPrep Course Book

NAPLEX-relevant updates from June 2021-May 2022

Page	Update Type	Description
Chapter 18: Renal Disease and Chapter 44: Diabetes
p. 292, 617	Labeling Change	Dapagliflozin (Farxiga) has been FDA-approved for adults with chronic kidney disease to reduce the risk of eGFR decline, end-stage renal disease, cardiovascular death and hospitalization for heart failure.
Chapter 20: Immunizations
p. 324-331	Guideline Update	The Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC) updated recommendations for several vaccines. Key changes that could impact testing include: Pneumococcal vaccines PCV13 (Prevnar 13) continues to be recommended for routine pneumococcal vaccination in children ≤ 18 years. There are three pneumococcal vaccines recommended for adults: Two conjugate vaccines: PCV15 (Vaxneuvance) and PCV20 (Prevnar 20) One polysaccharide vaccine: PPSV23 (Pneumovax 23) Adults aged 19–64 years with certain underlying medical conditions (see below) or age ≥ 65 years (if never received before): PCV20 x 1 or PCV15 x1 followed by PPSV23 x1 ≥ 12 months later (can be given ≥ 8 weeks later if immunocompromised) Certain underlying medical conditions (unchanged from prior recommendations; indicates an immunocompromised state): alcohol use disorder, cigarette smoking, diabetes, chronic heart, lung or liver disease, sickle cell disease/asplenia, taking immunosuppressive drugs* (e.g., chemotherapy, long-term systemic steroids), HIV infection, malignancy, solid organ transplant, chronic renal failure The update above applies to the following sections: p. 324 (Vaccinations for Special Groups): Older Adults, Diabetes, Sickle Cell Disease & Other Causes of Asplenia and Immunodeficiency boxes p. 325 (Vaccinations for Adults): Pneumococcal box p. 329-330: Pneumococcal Vaccines (including Study Tip Gal) Sickle Cell Disease, Asthma, Tobacco Cessation, Diabetes, and Transplant chapters Shingles vaccine p. 325 & 331: Shingrix recommendations have expanded to include adults aged ≥ 19 years if immunosuppressed (or expected to become immunosuppressed). This update also applies to p. 408 in the Infectious Diseases III: Antivirals and Antifungals chapter. Hepatitis B vaccine p. 325-326: a hepatitis B vaccination series is now recommended for all adults aged 19–59 years or age ≥ 60 years if at risk for hepatitis B virus infection (or want to receive vaccination). 2022 CDC Adult Immunization Schedule ACIP/CDC Pneumococcal Vaccine Recommendations
Chapter 23: Infectious Diseases II: Bacterial Infections
p. 383	Guideline Update	The Centers for Disease Control and Prevention (CDC) now recommend the following treatment options for latent tuberculosis (TB) in pregnant patients (without preference): Isoniazid and rifampin daily for 3 months Rifampin daily for 4 months Isoniazid daily for 6 or 9 months CDC TB and Pregnancy
p. 393	Guideline Update	The Infectious Diseases Society of America (IDSA) and the American College of Gastroenterologists (ACG) have both released updates for the treatment of Clostridioides difficile infection (CDI): First (initial) episode: preferred first-line treatment options remain the same (fidaxomicin or oral vancomycin). Second episode (first recurrence): can be treated with any of the following regardless of the antibiotic used for the initial episode (unless noted): Fidaxomicin 200 mg PO BID x 10 days Vancomycin tapered and pulsed regimen (e.g., vancomycin 125 mg PO QID for 10 days, then BID for one week, then once per day for one week, then every 2 or 3 days for 2-8 weeks) Vancomycin 125 mg PO QID x 10 days (if metronidazole was used to treat the initial episode) Subsequent episodes: treatment options for the third episode or greater remain the same. Bezlotoxumab has a more defined role in the prevention of recurrent CDI. It can be considered in high risk patients (e.g., age ≥ 65, immunocompromised, severe presentation and/or a second episode within the past 6 months) and must be used in combination with antibiotics active against C. difficile (e.g., fidaxomicin or oral vancomycin). A labeled warning advises caution when used in patients with a history of heart failure. IDSA/SHEA 2021 Focused Update on Management of Clostridioides difficile Infection in Adults ACG 2021 Clinical Guidelines for Clostridioides difficile Infections
p. 394	Guideline Update	The Sexually Transmitted Infections Treatment Guidelines, 2021 published by the Centers for Disease Control and Prevention contain an update for chlamydia treatment. The preferred regimens are: Non-pregnant adults: doxycycline 100 mg PO BID x 7 days Pregnant females: azithromycin 1 gram PO x 1 dose CDC Sexually Transmitted Infections Treatment Guidelines, 2021
Chapter 31: Chronic Heart Failure and Chapter 44: Diabetes
p. 482, 617	Labeling Change	Empagliflozin (Jardiance) has been FDA-approved to reduce the risk of cardiovascular death and hospitalization in patients with heart failure with reduced ejection fraction.
Chapter 34: Anticoagulation
p. 523	Guideline Update	The American College of Chest Physicians (CHEST) released a second update to the Antithrombotic Therapy for the Treatment of Venous Thromboembolism (VTE) Disease guideline: In patients with cancer-associated thrombosis, oral factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) are preferred over low molecular weight heparins (e.g., enoxaparin). CHEST 2021 Second Update of the Antithrombotic Therapy for VTE Disease Guideline
Chapter 44: Diabetes
p. 614-616	Guideline Update	The 2022 American Diabetes Association (ADA) Standards of Care update was published. Key changes that could impact testing include: Screening p. 614: everyone should be tested for diabetes beginning at 35 years old. Diabetic Kidney Disease p. 615: SGLT2 inhibitors are recommended in patients with an eGFR ≥ 25 mL/min/1.73m2 and urine albumin ≥ 300 mg/g to reduce CKD progression and cardiovascular events. Finerenone is recommended in patients unable to use an SGLT2 inhibitor. An ACE inhibitor or ARB continues to be recommended in patients with albuminuria. Treatment for Type 2 Diabetes p. 616: although metformin is still generally considered to be first-line, initial treatment depends on comorbidities and patient-specific factors. ADA Standards of Medical Care in Diabetes – 2022
Chapter 44: Diabetes and Chapter 57: Weight Loss
p. 618, 756	Labeling Change	Semaglutide (Wegovy) injection has been FDA-approved for weight management in adults with obesity or who are overweight with at least one additional weight-related condition (e.g., hypertension, type 2 diabetes, dyslipidemia).

Errata: 2022 UWorld RxPrep Course Book

Corrections or clarifications for the 2022 RxPrep Course Book

Page	Description
Chapter 15: Compounding I
p. 246	On the clipboard describing USP 797 cleaning requirements, the minimum frequency of cleaning the carts should be monthly.
Chapter 18: Renal Disease
p. 293	In the section under Collecting Duct, the second to last sentence in the paragraph should say, “Potassium-sparing diuretics (including aldosterone antagonists) work in the distal convoluted tubule and collecting duct to decrease Na and water reabsorption and increase K reabsorption.

2023 2022

Updates: 2023 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

Errata: 2023 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.

Guideline/Drug Updates: 2022 UWorld RxPrep Course Book

NAPLEX-relevant updates from June 2021-May 2022

Chapter 18: Renal Disease and Chapter 44: Diabetes
Page p. 292, 617		Update Type Labeling Change
Dapagliflozin (Farxiga) has been FDA-approved for adults with chronic kidney disease to reduce the risk of eGFR decline, end-stage renal disease, cardiovascular death and hospitalization for heart failure.
Chapter 20: Immunizations
p. 324-331		Update Type Guideline Update
The Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC) updated recommendations for several vaccines. Key changes that could impact testing include: Pneumococcal vaccines PCV13 (Prevnar 13) continues to be recommended for routine pneumococcal vaccination in children ≤ 18 years. There are three pneumococcal vaccines recommended for adults: Two conjugate vaccines: PCV15 (Vaxneuvance) and PCV20 (Prevnar 20) One polysaccharide vaccine: PPSV23 (Pneumovax 23) Adults aged 19–64 years with certain underlying medical conditions (see below) or age ≥ 65 years (if never received before): PCV20 x 1 or PCV15 x1 followed by PPSV23 x1 ≥ 12 months later (can be given ≥ 8 weeks later if immunocompromised) Certain underlying medical conditions (unchanged from prior recommendations; indicates an immunocompromised state): alcohol use disorder, cigarette smoking, diabetes, chronic heart, lung or liver disease, sickle cell disease/asplenia, taking immunosuppressive drugs* (e.g., chemotherapy, long-term systemic steroids), HIV infection, malignancy, solid organ transplant, chronic renal failure The update above applies to the following sections: p. 324 (Vaccinations for Special Groups): Older Adults, Diabetes, Sickle Cell Disease & Other Causes of Asplenia and Immunodeficiency boxes p. 325 (Vaccinations for Adults): Pneumococcal box p. 329-330: Pneumococcal Vaccines (including Study Tip Gal) Sickle Cell Disease, Asthma, Tobacco Cessation, Diabetes, and Transplant chapters Shingles vaccine p. 325 & 331: Shingrix recommendations have expanded to include adults aged ≥ 19 years if immunosuppressed (or expected to become immunosuppressed). This update also applies to p. 408 in the Infectious Diseases III: Antivirals and Antifungals chapter. Hepatitis B vaccine p. 325-326: a hepatitis B vaccination series is now recommended for all adults aged 19–59 years or age ≥ 60 years if at risk for hepatitis B virus infection (or want to receive vaccination). 2022 CDC Adult Immunization Schedule ACIP/CDC Pneumococcal Vaccine Recommendations
Chapter 23: Infectious Diseases II: Bacterial Infections
p. 383		Update Type Guideline Update
The Centers for Disease Control and Prevention (CDC) now recommend the following treatment options for latent tuberculosis (TB) in pregnant patients (without preference): Isoniazid and rifampin daily for 3 months Rifampin daily for 4 months Isoniazid daily for 6 or 9 months CDC TB and Pregnancy
p. 393		Update Type Guideline Update
The Infectious Diseases Society of America (IDSA) and the American College of Gastroenterologists (ACG) have both released updates for the treatment of Clostridioides difficile infection (CDI): First (initial) episode: preferred first-line treatment options remain the same (fidaxomicin or oral vancomycin). Second episode (first recurrence): can be treated with any of the following regardless of the antibiotic used for the initial episode (unless noted): Fidaxomicin 200 mg PO BID x 10 days Vancomycin tapered and pulsed regimen (e.g., vancomycin 125 mg PO QID for 10 days, then BID for one week, then once per day for one week, then every 2 or 3 days for 2-8 weeks) Vancomycin 125 mg PO QID x 10 days (if metronidazole was used to treat the initial episode) Subsequent episodes: treatment options for the third episode or greater remain the same. Bezlotoxumab has a more defined role in the prevention of recurrent CDI. It can be considered in high risk patients (e.g., age ≥ 65, immunocompromised, severe presentation and/or a second episode within the past 6 months) and must be used in combination with antibiotics active against C. difficile (e.g., fidaxomicin or oral vancomycin). A labeled warning advises caution when used in patients with a history of heart failure. IDSA/SHEA 2021 Focused Update on Management of Clostridioides difficile Infection in Adults ACG 2021 Clinical Guidelines for Clostridioides difficile Infections
p. 394		Update Type Guideline Update
The Sexually Transmitted Infections Treatment Guidelines, 2021 published by the Centers for Disease Control and Prevention contain an update for chlamydia treatment. The preferred regimens are: Non-pregnant adults: doxycycline 100 mg PO BID x 7 days Pregnant females: azithromycin 1 gram PO x 1 dose CDC Sexually Transmitted Infections Treatment Guidelines, 2021
Chapter 31: Chronic Heart Failure and Chapter 44: Diabetes
Page p. 482, 617		Update Type Labeling Change
Empagliflozin (Jardiance) has been FDA-approved to reduce the risk of cardiovascular death and hospitalization in patients with heart failure with reduced ejection fraction.
Chapter 34: Anticoagulation
Page p. 523		Update Type Guideline Update
The American College of Chest Physicians (CHEST) released a second update to the Antithrombotic Therapy for the Treatment of Venous Thromboembolism (VTE) Disease guideline: In patients with cancer-associated thrombosis, oral factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) are preferred over low molecular weight heparins (e.g., enoxaparin). CHEST 2021 Second Update of the Antithrombotic Therapy for VTE Disease Guideline
Chapter 44: Diabetes
Page p. 614-616		Update Type Guideline Update
The 2022 American Diabetes Association (ADA) Standards of Care update was published. Key changes that could impact testing include: Screening p. 614: everyone should be tested for diabetes beginning at 35 years old. Diabetic Kidney Disease p. 615: SGLT2 inhibitors are recommended in patients with an eGFR ≥ 25 mL/min/1.73m2 and urine albumin ≥ 300 mg/g to reduce CKD progression and cardiovascular events. Finerenone is recommended in patients unable to use an SGLT2 inhibitor. An ACE inhibitor or ARB continues to be recommended in patients with albuminuria. Treatment for Type 2 Diabetes p. 616: although metformin is still generally considered to be first-line, initial treatment depends on comorbidities and patient-specific factors. ADA Standards of Medical Care in Diabetes – 2022
Chapter 44: Diabetes and Chapter 57: Weight Loss
Page p. 618, 756		Update Type Labeling Change
Semaglutide (Wegovy) injection has been FDA-approved for weight management in adults with obesity or who are overweight with at least one additional weight-related condition (e.g., hypertension, type 2 diabetes, dyslipidemia).

Errata: 2022 UWorld RxPrep Course Book

Corrections or clarifications for the 2022 RxPrep Course Book

Chapter 15: Compounding I
Page p. 246
On the clipboard describing USP 797 cleaning requirements, the minimum frequency of cleaning the carts should be monthly.
Chapter 18: Renal Disease
Page p. 293
In the section under Collecting Duct, the second to last sentence in the paragraph should say, “Potassium-sparing diuretics (including aldosterone antagonists) work in the distal convoluted tubule and collecting duct to decrease Na and water reabsorption and increase K reabsorption.

MPJE

MPJE Updates: 7th Edition Federal Law Summary for MPJE

MPJE-relevant updates from January 2021–Present

Page

Update Type

Description

Chapter 1: Preparing for MPJE with RxPrep

p. 3-4

Revised NABP MPJE Competency Statements

Effective March 2023

NABP has released revised MPJE Competency Statements (their blueprint of tested items).

Impact for MPJE Candidates testing after March 1, 2023:

The 2023 MPJE Competency Statements have been reorganized across more “Areas.”
The types of questions and general format of the exam (e.g., number of questions and time to take the test) is the same.
The must-know content has not changed. Continue to use the RxPrep MPJE Course materials for your MPJE preparation.

Comparison of previous and new MPJE Competency Areas:

Previous MPJE Competency Statement Areas, Prior to March 2023 (Three Areas)	New MPJE Competency Statement Areas, Starting March 1, 2023 (Four Areas)
Area 1 (83%) Pharmacy Practice	Area 1 (22%) Licensure/Personnel
Area 2 (15%) Licensure, Registration, Certification and Operational Requirements	Area 2 (33%) Pharmacist Practice
Area 3 (2%) General Regulatory Processes	Area 3 (24%) Dispensing Requirements
	Area 4 (21%) Pharmacy Operations

Exam content will be distributed more evenly between the new Competency Areas. While the previous Area 3 of “General Regulatory Process” is not included in the new statements, the application of the material is likely still testable. For example:

The previous Area 3 competency statement (3.1) focused on knowing specific laws and rules like the the Food, Drug, and Cosmetic Act.
The new Area 3 competency statement (3.7) “drug product conditions prohibiting dispensing” may refer to misbranding and adulteration, which arose out of the Food, Drug, and Cosmetic Act.

Previous MPJE Competency statements (Prior to March 2023)
New MPJE Competency Statements (Starting March 2023)

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:

Insulin glargine-ygfn (Semglee) for insulin glargine (Lantus)
Adalimumab-adbm (Cyltezo) for adalimumab (Humira)

Chapter 8: Controlled Substance Part 3: Prescribing and Dispensing

p. 137, 154 -155

Law Update

Effective June 2023

The following update impacts these sections:

P. 137, second paragraph regarding the DATA 2000 waiver unique identification number
P. 154-155, the section on Opioid Dependence Treatment in an Office-Based Setting

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.

A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.
All prescriptions for buprenorphine now require only a standard DEA registration number (previous “X” in DEA number is no longer required).
There are no longer any limits on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
The Act does not impact existing state laws that may be applicable.

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: Insulin glargine-ygfn (Semglee) for insulin glargine (Lantus) Adalimumab-adbm (Cyltezo) for adalimumab (Humira)

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

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: Insulin glargine-ygfn (Semglee) for insulin glargine (Lantus) Adalimumab-adbm (Cyltezo) for adalimumab (Humira)
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: p. 96: Butalbital-containing products row p. 98: State-specific Scheduling section p. 98: Barbiturate Schedules section (second bullet point) A.B. 527, California 2021
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: Loss of any quantity due to employee theft. Tablets, capsules or oral medications in a quantity ≥ 99 dosage units. Single-dose injectable medications, lozenges, films (oral, buccal, sublingual), suppositories or patches in a quantity ≥ 10 dosage units. Multi-dose medications (e.g., vials, containers) or medications administered by continuous infusion in a quantity ≥ 2 units. Any loss deemed significant by the pharmacist-in-charge. 16 CCR § 1715.6
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: In addition to the features noted on p. 120 and 121, security prescription forms must now contain a barcode and the prescriber’s pre-printed address. The serial number formatting has also changed from 15 digits (3 letters followed by 12 numbers) to 12 digits (any combination of letters and numbers) that corresponds with the barcode. The Script March 2021 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: Prescriptions issued by a veterinarian. Prescriptions issued in a hospital emergency department or urgent care clinic if the patient is homeless without a preferred pharmacy, the patient lives outside of California or the geographic area of the hospital/clinic, or the prescription is issued when the preferred pharmacy is closed. The prescription will be dispensed outside of California. Electronic data transmission is not available due to a temporary technological or electrical failure. The Script, September 2021
p. 117, 131 – 132	Law Update Effective June 2023	The following update impacts these sections: P. 117, second paragraph regarding the DATA 2000 waiver unique identification number and the Study Tip. P. 131-132, the section on Opioid Dependence Treatment in an Office-Based Setting 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. A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder. All prescriptions for buprenorphine now require only a standard DEA registration number (previous “X” in DEA number is no longer required). There are no longer any limits on the number of patients a prescriber may treat for opioid use disorder with buprenorphine. The Act does not impact existing state laws that may be applicable. DEA Informational Document

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: Insulin glargine-ygfn (Semglee) for insulin glargine (Lantus) Adalimumab-adbm (Cyltezo) for adalimumab (Humira)
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: p. 96: Butalbital-containing products row p. 98: State-specific Scheduling section p. 98: Barbiturate Schedules section (second bullet point) A.B. 527, California 2021
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: Loss of any quantity due to employee theft. Tablets, capsules or oral medications in a quantity ≥ 99 dosage units. Single-dose injectable medications, lozenges, films (oral, buccal, sublingual), suppositories or patches in a quantity ≥ 10 dosage units. Multi-dose medications (e.g., vials, containers) or medications administered by continuous infusion in a quantity ≥ 2 units. Any loss deemed significant by the pharmacist-in-charge. 16 CCR § 1715.6
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: In addition to the features noted on p. 120 and 121, security prescription forms must now contain a barcode and the prescriber’s pre-printed address. The serial number formatting has also changed from 15 digits (3 letters followed by 12 numbers) to 12 digits (any combination of letters and numbers) that corresponds with the barcode. The Script March 2021 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: Prescriptions issued by a veterinarian. Prescriptions issued in a hospital emergency department or urgent care clinic if the patient is homeless without a preferred pharmacy, the patient lives outside of California or the geographic area of the hospital/clinic, or the prescription is issued when the preferred pharmacy is closed. The prescription will be dispensed outside of California. Electronic data transmission is not available due to a temporary technological or electrical failure. The Script, September 2021

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