2015, Labelling and Packaging - Pharmacy Technician Pulse

Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

AUGUST 23, 2022

However, the researchers noted that a larger number of warning letters were issued to pharmaceutical manufacturers (ie, by CDER) than to medical device manufacturers (by CDRH) between 2015 and 2020. The major reasons for this were poor cGMP compliance and misbranding.

FDA

FDA Documentation Packaging Labelling

FDA Issues Long-Awaited QMSR Final Rule

The FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

FDA

FDA Labelling Packaging Documentation

Can you drink on Mucinex?

The Checkup by Singlecare

JANUARY 4, 2024

Always follow the directions on the packaging or consult a healthcare professional if you have concerns about the appropriate dosage. In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day.

Immunization

Immunization Labelling Dosage Medication Labelling

Can you get diabetes from eating too much sugar?

The Checkup by Singlecare

NOVEMBER 3, 2023

Read food labels carefully. When buying packaged foods, carefully scan the label and look for added sugars. “Fruits are and should be one of the main components in our daily meals,” says Dr. Makhija. Fruit is a power-packed food and provides nutrients beyond the ‘sweet’ component of it.” Added sugar can go by many names.

Labelling

Labelling Packaging Immunization

FDA Publishes Proposal to Redefine the Implied Nutrient Contain Claim “Healthy” Changing Focus to Foods Rather than Nutrients Adding Limits on Added Sugar Content

The FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.

FDA

FDA Labelling Packaging Documentation

Benefits of chlorophyll for lung health and more

The Checkup by Singlecare

FEBRUARY 2, 2024

Currently, there’s no recommended daily allowance, but product labels may recommend drinking 100–200 milligrams daily, depending on the product. However, if you do choose to try a supplement containing chlorophyllin, read the label carefully and look for a third-party certification. Pharmacopeia , UL Solutions , and Consumer Lab.

Compounding

Compounding Labelling Packaging

Improving access to treatments in challenging markets

pharmaphorum

AUGUST 25, 2021

In 2015, PEPFAR reached out to Gilead and said they were working with the government in Sub-Saharan Africa. If you get past the regulatory hurdles, then you have to look at labelling requirements, packaging requirements, and quality assurance requirements.”.

Packaging

Packaging Compounding FDA Labelling

10 Things To Do To Lower Your Toxic Burden

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! 27 April 2015. Endocrine Research.

Health and Personal Care Stores

Health and Personal Care Stores Packaging Compounding Labelling

DSCSA Postponement And What It Means For Independent Pharmacies

DiversifyRx

JULY 11, 2024

Most of the existing requirements have been in place since 2015 and require Pharmacies to have SOPs, Training, and data storage (or agreements with their ATPs in place) to maintain the required transaction data. The four requirements below are handled in various ways.

Independent Pharmacies

Independent Pharmacies FDA Documentation CPhT

Lion’s mane mushroom benefits

The Checkup by Singlecare

DECEMBER 26, 2023

A supplement package may claim it contains lion’s mane mushroom, but it may not specify what part of the mushroom it’s made from. Dr. Cooperman warns consumers not to place too much trust in lion’s mane supplement labels. In this form, you generally get a very low-potency product that may or may not work.” Dr. Cooperman explains.

Immunization

Immunization Dosage Packaging FDA

Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

MARCH 15, 2023

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). October 2015. 7 An integrative (vs.

Packaging

Packaging Labelling Health Compliance Process Improvement

Hashimoto’s and Graves’ Remission after Helicobacter Pylori Eradication

The Thyroid Pharmacist

AUGUST 19, 2022

In 2015, 80 percent of my clients who hit a plateau with nutrition and took the gut tests I recommended, tested positive for at least one gut infection. MegaGuard and PyloGuard provide doses on the package. doi: 10.1515/cipms-2015-0038. Published 2015 Jul 16. Gut Infections and Autoimmunity. 39,64-67). 2018; 28(1): 30-32.

Health and Personal Care Stores

Health and Personal Care Stores Immunization Insurance Packaging

9 Sneaky Thyroid Toxins Hiding in Your Home

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.

Health and Personal Care Stores

Health and Personal Care Stores Labelling Immunization Packaging

Is 2023 the Year for OTC Naloxone?

The FDA Law Blog

FEBRUARY 16, 2023

While laypeople are already using NNS in a number of states, FDA has cautioned that the current community use differs from OTC use because many of these programs provide patient counseling and instructions for use that go beyond what is included in the current NNS labeling. including a QR code that links to additional training).

Labelling

Labelling Packaging FDA

What are the side effects of Bactrim for older adults?

The Checkup by Singlecare

JANUARY 18, 2024

Follow the instructions on your prescription label. Start by reading the package insert, and ask your pharmacist questions if there’s anything you don’t understand. It’s essential that your healthcare provider know everything that you are taking before they prescribe Bactrim, as it can have interactions. Stay hydrated.

Mayo Clinic

Mayo Clinic Adverse Reactions Packaging Labelling

10 reasons to consider NAC supplements

The Checkup by Singlecare

FEBRUARY 16, 2024

“Antioxidant” has become a hyper-common wellness buzzword, slapped on health food packages so often that many people don’t think twice about it. One small study from 2015 showed that some people who took NAC for four weeks saw decreases in systolic blood pressure and diastolic blood pressure. But it’s not just a long-term treatment.

Immunization

Immunization Dosage Packaging Documentation

Navigating the unique CMC challenges of oral anaerobic live biotherapeutics

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. 2015; 69(1):381–403 5. Leveraging Quorum Sensing to Manipulate Microbial Dynamics. 2021; 19:100306 4.

Dosage

Dosage Packaging Compounding Labelling

Pharmacologic Management of Crotalid Envenomation

Pharmacy Friday Pearls

MARCH 9, 2022

Crofab ® [package insert]. Anavip ® [package insert]. in the treatment group vs 7.4 in the control group (95% CI 0.1 – 2.3; in the treatment group vs 7.4 in the control group (95% CI 0.1 – 2.3; Available at: [link] Accessed April 28, 2020. West Conshohocken, PA: BTG International Inc; 2000. Crotalidae Immune F(ab’)2 (Equine).

Immunization

Immunization Packaging Labelling FDA

Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

JULY 29, 2022

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. But formaldehyde has been labeled as a known human carcinogen by the U.S. Sinus problems.

Health and Personal Care Stores

Health and Personal Care Stores Compounding Immunization Labelling

Eric Halioua, President & CEO at PDCline Pharma Shares Insights on the Results from P-I/II Trial with PDClung01

PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC). 2015; Zhu et al.,

Immunization

Immunization Vaccines Health and Personal Care Stores Labelling

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