ISPE

APRIL 13, 2023

1 More recently, regulators like the FDA have increasingly promoted the benefits of modeling (e.g., Topics in Chemical Engineering, 2003. Biopharma Adopts Mechanistic Modeling Mechanistic modeling has been widely used in the petrochemical industry for many decades, while biochemical producers have been slower to adopt. Melton, and E.

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The Checkup by Singlecare

MARCH 21, 2024

A 2003 law prohibits government-sponsored plans like Medicare from covering weight loss medication. Consider a compounded version For drugs on the Food and Drug Administration (FDA) shortage list, compounding pharmacies can create and sell copies, often at lower prices than the brand-name versions.

Insurance 52

Insurance Insurance Coverage Mail-Order Pharmacies Dosage 52

Drug Topics

JUNE 8, 2025

J Am Pharm Assoc (2003). J Am Pharm Assoc (2003). BMC Health Serv Res. 2005;5(1):3. doi:10.1186/1472-6963-5-3 6. Manzur V, Mirzaian E, Huynh T, et al. Implementation and assessment of a pilot, community pharmacy-based, opioid pain medication management program. 2020;60(3):497-502. doi:10.1016/j.japh.2019.11.029 2019.11.029 7.

Independent Pharmacies 354

Independent Pharmacies Community Pharmacies Compounding Vaccines 354

ISPE

NOVEMBER 2, 2022

Those began 20 years ago when he was involved in a major FDA inspection by Robert Tollefsen and Thomas Arista that significantly changed computer system validation in the industry. “As As a result, I was asked to present learning points and outcomes of that inspection at a GAMP Forum in San Francisco in January 2003.

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PharmaShots

JUNE 28, 2023

Consistent with prior periods, Enbrel continued to lose market share, and this decline was compounded by a reduction in the growth rate of the rheumatology market as a result of COVID-19. Generally, these reviews are helpful when consumers research the product and read multiple reviews before buying it.

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Pharmacy Times

JUNE 23, 2025

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.

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Drug Topics

JUNE 17, 2025

J Am Pharm Assoc (2003). References 1. Fick G, Osei J, Kim S, et al. A narrative literature review: Community pharmacy technician well-being and its implications. 2025 May 9:102419. doi: 10.1016/j.japh.2025.102419. 2025.102419. Epub ahead of print. PMID: 40349976.

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Community Pharmacies CPhT Immunization Vaccines 217

ISPE

MAY 9, 2023

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. Published February 2003. Published February 2003.

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Drug Topics

JUNE 16, 2025

J Am Pharm Assoc (2003). link] August 21, 2024 Accessed June 11, 2025. Meyerson BE, Richter S, Gordon R, et al. Pharmacy harm reduction practices to help reduce opioid overdoses, Arizona 2023. 2025;65(3):102348. doi:10.1016/j.japh.2025.102348

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Specialty Pharmacies Compounding Communication Independent Pharmacies 247

Pharmacy Times

JUNE 18, 2025

J Am Pharm Assoc (2003). Am J Health Syst Pharm. 2019;76(4):251-253. doi:10.1093/ajhp/zxy040 13. Foster AA, Daly CJ, Logan T, et al. Implementation and evaluation of social determinants of health practice models within community pharmacy. 2022;62(4):1407-1416.doi:10.1016/j.japh.2022.02.005 doi:10.1016/j.japh.2022.02.005

Immunization 65

Immunization Compounding Pharmacies Hospitals Chemotherapy 65

The Checkup by Singlecare

FEBRUARY 6, 2024

Food and Drug Administration (FDA). Since atomoxetine treats attention-deficit hyperactivity disorder by being a selective norepinephrine reuptake inhibitor and since norepinephrine is an adrenaline compound, MAOIs are hazardous if taken concurrently or within 14 days of atomoxetine. MAOIs can lead to an increase in adrenaline.

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ISPE

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.

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Vaccines Compounding Documentation FDA 97

Drug Topics

JULY 10, 2025

J Am Pharm Assoc (2003). Perepelkin J, Antunes K, Boechler L, et al. Providing mindfulness meditation for patients with depression and anxiety in a community pharmacy: A pilot study. 2019 Mar-Apr;59(2):258-264. doi: 10.1016/j.japh.2018.10.017. 2018.10.017. Epub 2018 Dec 11. PMID: 30552050. Newsletter Pharmacy practice is always changing.

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Community Pharmacies Specialty Pharmacies Compounding Independent Pharmacies 282

PharmaShots

FEBRUARY 20, 2023

Since time immemorial, plants have been widely used as a source of medicinal compounds. However, upstream production in plants must also comply with additional laws relating to environmental release if grown outdoors (Directive 2001/ 18/EC, and 1829/2003/EC if the crop can be used as food/ feed) and Directive 2009/41EC if grown in constraint.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Compounding 40

Pharmacy Times

JUNE 11, 2025

J Am Pharm Assoc (2003). 2022;28(11):2238-2240. doi:10.1038/s41591-022-02027-3. Fera T, Bluml BM, Ellis WM. Diabetes Ten City Challenge: final economic and clinical results. 2009;49(3):383-391. doi:10.1331/JAPhA.2009.09015 2009.09015 Blalock SJ, Roberts AW, Lauffenburger JC, Thompson T, O'Connor SK.

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Compounding Pharmacies Grocery Stores Hospitals Vaccines 81

The FDA Law Blog

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. FDA has not approved marijuana for medical use because no double-blind, published studies show safety and efficacy for raw marijuana. In other words, no rescheduling.

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Controlled Substances Chemotherapy FDA Compounding 59

The Thyroid Pharmacist

JULY 20, 2023

Just this year, the FDA approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia caused by chronic kidney disease, for adults who have been receiving dialysis for at least four months. [58] There are various iron salts, or compounds, and each of them have different levels of elemental iron in them. [63]

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Pharmacy Times

JUNE 12, 2025

Bush’s Medicare Modernization Act (MMA) of 2003, and with it drug coverage for tens of millions of Medicare enrollees for the first time in program history. From a coverage perspective, Part D has been a success, with older Americans paying far less for drugs than they otherwise would have prior to MMA 2003. Add President Joseph R.

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