Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

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Biosimilars Packaging Labelling Drug Development 130

pharmaphorum

AUGUST 19, 2020

The Patient-to-Patient Supply for Cell Immunotherapies Summit (October 29-30, 2020) is a unique two-day digital platform discussing best practises in implementing robust vein-to-vein supply chains. Reggie Foster , Senior Director Labelling, Logistics & Packaging, Kite: a Gilead Company.

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Packaging Labelling 52

RX Note

DECEMBER 25, 2024

Strategies for sodium reduction include Make reading food labels a habit. meats, fruits and vegetables) rather than their packaged counterparts. When available, buy low-sodium, reduced-sodium or no-sodium versions of foods (e.g. breakfast cereals, canned or frozen foods). Rinse canned foods to remove some sodium.

Community Pharmacies 40

Community Pharmacies Packaging Labelling Diabetes 40

Express Pharma

SEPTEMBER 8, 2023

What use does the label serve, and who is responsible for making sure the QR code is still working when it changes commercial hands? What assurance is there that counterfeiters who can easily mimic a brand’s packaging, name, and logo won’t also be able to mimic its QR codes? It is useless if the QR codes are broken.

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European Pharmaceutical Review

SEPTEMBER 2, 2022

Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; June 2020. US Food and Drug Administration. Available from: [link].

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Adverse Reactions Documentation Medical Schools Packaging 96

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Whether a firm used the 10-day call and/or an SIR, it should include any prior feedback from those interactions with FDA in the AI response and describe how and where in the AI response package the prior feedback was addressed.

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RX Note

OCTOBER 5, 2023

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

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Health and Personal Care Stores Labelling Packaging Compounding 52

Pulses

AUGUST 31, 2023

doi:10.1108/IJILT-06-2020-0108 Reiners D, Davahli MR, Karwowski W, Cruz-Neira C. Onime C, Uhomoibhi J, Wang H, Santachiara M. A reclassification of markers for mixed reality environments. Campus-wide information systems. 2021;38(1):161-173. The combination of Artificial Intelligence and Extended Reality: A Systematic Review. 2021;2:721933.

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Medication Dispensing Medication Labelling Packaging Labelling 78

RX Note

JUNE 5, 2023

A simple method is to use a small adhesive label to mark the position and thus produce a measure with just one graduation.) Furthermore, in late August 2020, the FDA approved labelling changes for hydrochlorothiazide (HCTZ) to inform clinicians and patients about the slight risk of developing non-melanoma skin cancer.

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Compounding Labelling Packaging Hospitals 52

RX Note

JULY 14, 2023

Moreover, even after the MDI delivers the number of puffs stated on their label, it may look, taste and feel like it is still working, but the dose delivered may be very low. However, this floating/immersion technique is no longer endorsed since it can reduce the ability of the MDI to work properly. suds intact).

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RX Note

SEPTEMBER 23, 2023

Moreover, even after the MDI delivers the number of puffs stated on their label, it may look, taste and feel like it is still working, but the dose delivered may be very low. However, this floating/immersion technique is no longer endorsed since it can reduce the ability of the MDI to work properly. suds intact).

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Packaging Labelling 52

European Pharmaceutical Review

FEBRUARY 22, 2023

The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. Results from the first open-label, single-centre study of RT-101,6 which was conducted in Australia, were reported at the start of 2020. the enteric coating and the capsule dissolve.

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Biosimilars Diabetes Immunization Immunity 105

The Luxe Pharmacist

JANUARY 23, 2022

I personally had set a goal of becoming board certified as soon as possible after completing residency, which I accomplished back in the fall of 2020 and believe wholeheartedly that it was worth it for many reasons. Sets you apart from other pharmacists. Comparable to other healthcare professions. years later!

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Packaging Labelling 52

Birth Control Pharmacist

SEPTEMBER 20, 2021

While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Nextstellis (Drospirenone and Estetrol) [package insert]. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Published April 7, 2020.

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Adverse Reactions Packaging Labelling Diabetes 52

pharmaphorum

AUGUST 25, 2021

If you get past the regulatory hurdles, then you have to look at labelling requirements, packaging requirements, and quality assurance requirements.”. When working with different governments hurdles may occur for pharma companies, such as regulatory requirements. “If About the interviewee.

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Packaging Labelling Compounding 52

The Thyroid Pharmacist

SEPTEMBER 6, 2023

Personal Care : The Wellnesse line of haircare and toothpastes by Katie Wells (aka the “Wellness Mama”) contains high-quality, safe ingredients that are clearly labeled, so there are no surprises! They even have a trial package , so you can test their products out and see how they work for you! Accessed March 30, 2020.

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Health and Personal Care Stores Packaging Labelling Compounding 94

GMPSOP

JUNE 28, 2024

Packaging/labeling/Misbranding: 41 warnings vi. In 2019 and 2020, warning letters were issued for “Adulterated Food and Supplements” at 36% and 33%, respectively. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. . CGMP Deviation: 39 warnings ii.

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Documentation Packaging Labelling Pharmaceutical Manufacturing 59

The Thyroid Pharmacist

AUGUST 19, 2022

MegaGuard and PyloGuard provide doses on the package. pylori during the initial 2020 quarantine period. Published 2020 Jun 12. Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial. Accessed August 5, 2020. Published 2020 Jan 29.

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Health and Personal Care Stores Immunization Immunity Dosage 98

European Pharmaceutical Review

NOVEMBER 24, 2022

Indeed, a 2020 operation coordinated by Europol across 27 countries led to the seizure of more than 25 million units of counterfeit anticancer drugs and erectile dysfunction medicines among other fake drugs worth nearly €73 million. One area in which the problem can be tackled effectively is product packaging.

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Packaging Labelling Documentation Dosage 111

GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. Store all labels and leaflets in a locked room. Cross contamination data that can make you nervous!

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Health and Personal Care Stores Labelling Packaging Documentation 52

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 10] Its not only found in obvious sources like plastic containers and packaging, but also in the lining of canned foods and drinks, receipts, toys, electronics, and household items.

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Health and Personal Care Stores Labelling Immunization Immunity 66

pharmaphorum

SEPTEMBER 15, 2022

It had been held up in the US by compliance issues that forced Mallinckrodt to change its packaging and labelling manufacturing facility and resulted in the FDA rejecting its application in February.

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Packaging Labelling 98

pharmaphorum

JUNE 15, 2022

The Dublin, Ireland-headquartered company said the resubmission will allow more time for the FDA to inspect a packaging and labelling manufacturing facility for the drug, which as a result of a COVOD-19 backlog could not be completed before its deadline to review the original application. There is no FDA-approved therapy available.

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pharmaphorum

FEBRUARY 23, 2022

The FDA has issued a complete response letter to Mallinckrodt for terlipressin, on the grounds that the company had been forced to change its packaging and labelling manufacturing facility for the drug.

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Packaging Labelling 59

The Thyroid Pharmacist

JULY 29, 2022

I was inspired to write this blog after the September 2020 Cameron Peak fires in Colorado. Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Immunity 52

European Pharmaceutical Review

FEBRUARY 14, 2024

Flexibility in packaging and label design may also be necessary, particularly where the physical dose size may require to be modified due to potency variations or multiple units may requiring dosing to achieve the target dose. 2020; 144:104160 3. cited 2023Nov]. Available from: [link] 2. Zubair M, Khan FA, Menghwar H et al.

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Pharmacy Friday Pearls

MARCH 9, 2022

Available at: [link] Accessed April 28, 2020. Crofab ® [package insert]. Available at: [link] Accessed April 28, 2020. Anavip ® [package insert]. in the treatment group vs 7.4 in the control group (95% CI 0.1 – 2.3; Riverwoods, IL. West Conshohocken, PA: BTG International Inc; 2000. Lexi-Drugs. Wolters Kluwer Health, Inc.

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Immunization Immunity Packaging Labelling 40

Pharma in Brief

JANUARY 9, 2022

In response to the COVID-19 pandemic, in 2020, the Minister of Health signed interim orders designed to streamline the process to authorize the importation or sale of drugs, vaccines, and medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Major Policy Initiatives. (a) a) COVID-19.

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The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. Follow package directions for each supplement. Precautions Do not take more than the recommended dose on the label. If you’re experiencing these symptoms, reduce your dosage to ⅛ teaspoon daily, increasing usage slowly, as tolerated, to get to the recommended label usage.

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Health and Personal Care Stores Immunization Immunity Compounding 104

PharmaShots

MARCH 9, 2023

Designation: Chief Commercial Officer (CCO) and President Award & Nominations: She has her mention in Fortune’s “Top 50 Most Powerful Women” in 2020, 2021, and 2022 ranking 16th, 11th, and 13th respectively. Present company and time period: Pfizer (26 yrs.) She was also selected as the 39th Robert S.

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Clinical Pharmacology Immunization Immunity Pharmaceutical Companies 40

Pharmaceutical Technology

JULY 14, 2022

Pharmaceutical companies regularly outsource different steps of drug manufacturing processes like parenteral manufacturing and packaging, solid dose, and small molecule or biologic active pharmaceutical ingredient (API) production, among others. Several companies have been charged with manufacturing different components of J&J’s vaccine.

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PharmaTech

JUNE 12, 2025

. | Image Credit: © Tada Images - stock.adobe.com In a June 10, 2025 update, FDA posted seven updated Warning Letters, issued between the beginning of 2025 and the present, to its online database, which stores more than 3400 such letters dating back to 2020 (1).

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RX Note

FEBRUARY 9, 2025

Introduction A unit-dose medication distribution system uses medications packaged in unit-dose or single-unit packages. A single-unit package contains one dosage form of medication (e.g., A unit-dose package contains the dose of a medication ordered for a patient (e.g. Do not prepare extra labels.

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Packaging Labelling Dosage Documentation 40

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night. Figures - Elemental iron and calcium content?

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

Ramblings of a pharmacist

OCTOBER 26, 2022

In July 2020, a pharmacy in Brawley, CA was attempting to obtain Biktarvy® for their patients at a price that would sustain the pharmacy practice – i.e. a price that is less than the insurance’s allowed amount. The result of this will absolutely be that counterfeit medications WILL make their way into the drug supply chain.

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Documentation Labelling Independent Pharmacies Community Pharmacies 40