National Association of Boards of Pharmacy

OCTOBER 23, 2024

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.

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Packaging Documentation Pharmacy Technician 49

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement.

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Labelling Packaging Documentation 59

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

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Documentation Packaging Clinical Pharmacology Drug Development 59

Quality Matters

NOVEMBER 5, 2024

API DMFs are documents containing information on APIs that are submitted to the U.S. Food and Drug Administration (FDA) by API manufacturers to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.

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Pharmaceutical Manufacturing Packaging Documentation 78

National Association of Boards of Pharmacy

JULY 19, 2024

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. Gathering transaction information for recalls at the package level.

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Pharmacy Technician Documentation Communication Packaging 45

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Despite the removal of some of the most controversial proposals, the final rule still contains a variety of significant changes, which become effective on November 19, 2024. The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g.,

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Vaccines Inpatient Packaging Documentation 59

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. Eric Halioua: We forecast to get the final report of the current clinical trial (P-I/II PDC-LUNG-101 trial) in Q2 2024. Smriti: Please share the development timeline for the PDC*lung01, when can we expect the next phase of development?

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Immunity Immunization Vaccines Health and Personal Care Stores 40

Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Intensive care medicine , 33 (11), 2019–2024. Greene et al., Potassium was maintained within low normal range (3.8-4.0

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Packaging Documentation 52