Transformative Technologies Present Opportunities for Pharmacy Practice and Regulation

Posted by in Pharmacies and Pharmacists, State and Federal Regulatory Issues

A pharmacist using technology

From new uses and strategies related to central fill to improvements in telepharmacy, transformative technologies continue to empower pharmacists to deliver more efficient and effective services.   So, what new tools are in the adoption phase today? What pharmacy practice innovations are on the next horizon? What legislative and regulatory efforts are currently in progress that […]

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Driving Provider Value for Specialty Pharmacies

Posted by in Pharmacies and Pharmacists, State and Federal Regulatory Issues

A pharmacist prepares specialty drugs.

Launched in 2019, NABP’s Specialty Pharmacy Accreditation was created to accredit pharmacies providing advanced levels of pharmacy services and disease management tools for patients taking medications that require special handling, storage, and dispensing requirements. In addition, this accreditation is ideal for pharmacies that provide pharmacist coordinated patient education and training, such as promoting adherence and […]

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FDA’s DSCSA Exemption for Connected Trading Partners

Posted by in Pharmacies and Pharmacists, State and Federal Regulatory Issues

Two pharmacist check DSCSA requirements.

Full enforcement of the Drug Supply Chain Security Act (DSCSA) was set to begin on November 27, 2024, at the conclusion of the one-year FDA Stabilization Period. On October 10, 2024, U.S. Food & Drug Administration (FDA) issued an exemption notice for certain DSCSA requirements.   We support this decision. FDA took the right approach balancing the advancement […]

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NABP’s Compounding Pharmacy Accreditation Shows Your Pharmacy’s Alignment to USP Standards

Posted by in Pharmacies and Pharmacists, State and Federal Regulatory Issues

Pharmacist compounding a drug

On November 1, 2023, long-awaited revisions to the United States Pharmacopeia (USP) Chapters <795>: Pharmaceutical Compounding – Nonsterile Preparations and <797>: Pharmaceutical Compounding – Sterile Preparations became official. Chapters <795> and <797> present the standards for preparing compounded medications. The revisions to <795> and <797> reflect advancements in medical science that help ensure patients can access high-quality, safely prepared compounded medicines. Adhering to […]

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NABP’s Digital Pharmacy Accreditation Program Celebrates its 25th Anniversary

Posted by in Pharmacies and Pharmacists, State and Federal Regulatory Issues

A man selecting information about medication.

NABP’s Digital Pharmacy Accreditation Program, the 3-year accreditation for pharmacies that have a website offering at least one interactive pharmacy practice component, has been protecting patients online since 1999. Our “Gen Z” accreditation program is now turning 25, and in its quarter-century lifespan, the internet has moved from our family computer rooms to our pockets, ingrained […]

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Satisfy Online Ad Requirements with NABP’s Healthcare Merchant Accreditation

Posted by in Pharmacies and Pharmacists, State and Federal Regulatory Issues

Four health care workers.

If you are involved in the business of health care, it’s likely that you could benefit from obtaining our Healthcare Merchant Accreditation. As our broadest and most accessible accreditation program, Healthcare Merchant Accreditation is offered to both brick-and-mortar businesses and online-only enterprises around the world, enabling your business to meet requirements to advertise on platforms […]

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FDA’s Small Dispenser DSCSA Exemption

Posted by in Boards of Pharmacy and NABP, State and Federal Regulatory Issues

Illustration of a person looking at a checklist of requirements.

What does FDA’s Small Dispenser Exemption really mean?   On June 12, 2024, Food and Drug Administration (FDA) issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements of section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026.    For purposes of the exemption, a dispenser […]

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Preparing for an Inspection or Accreditation Survey – Part 2

Posted by in Boards of Pharmacy and NABP, State and Federal Regulatory Issues

Three people looking at to do items on a clipboard.

This blog post is continued from Preparing for an Inspection or Accreditation Survey –  Part 1. Read part 1 for more information on preparing for an on-site visit by a third-party organization or regulatory agency for an inspection, survey, or review of your operations.   Conduct Mock On-site Visits  One of the best ways to […]

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Preparing for an Inspection or Accreditation Survey – Part 1 

Posted by in Boards of Pharmacy and NABP, State and Federal Regulatory Issues

Two pharmacists talking.

Whether you are opening a new facility, seeking an accreditation, or operating business as usual, at some point, you will encounter a third-party organization or regulatory agency. These groups will come on-site for a visit to inspect, survey, or review your operations. Preparation for this on-site visit is the key to a successful outcome.  Steps […]

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What Trading Partners Need to Know Before the DSCSA Deadline 

Posted by in Pharmacies and Pharmacists, State and Federal Regulatory Issues

A person reviewing regulatory requirements.

Full implementation of the Drug Supply Chain Security Act (DSCSA) was to begin on November 27, 2023. However, on August 25, 2023, US Food & Drug Administration (FDA) issued what it refers to as a “Stabilization Policy,” — a one-year period of non-enforcement for certain DSCSA requirements. In our view, FDA expects drug supply chain […]

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