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FDA releases policy documents on compounding, including a draft interim guidance and a final guidance

BY Michael Johnsen

 
 
SILVER SPRING, Md. – The Food and Drug Administration on Tuesday issued several policy documents regarding compounding as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act enacted in November 2013. 
 
The policy documents consist of a draft interim guidance, a proposed rule, a final guidance and two revised requests for nominations for the bulk drug substances lists. 
 
“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”
 
The draft interim guidance outlines the FDA’s expectations regarding compliance with current good manufacturing practice requirements for facilities that compound and register with the FDA as outsourcing facilities under section 503B of the Federal Food, Drug and Cosmetic Act. The guidance focuses on cGMP requirements related to sterility assurance of sterile drug products and the general safety of compounded drug products.  
 
The final guidance is for individuals or pharmacies that intend to compound drugs under section 503A, now that the FD&C Act has been amended by the DQSA. The guidance generally restates the provisions of section 503A, describes the FDA’s interim policies with respect to specific provisions that require implementing regulations or other actions and contains a non-exhaustive list of potential enforcement actions against individuals or pharmacies that compound human drug products in violation of the FD&C Act.
 

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Doritos Loaded debut at 7-Eleven

BY Ryan Chavis

DALLAS — PepsiCo and 7-Eleven on Wednesday announced the launch of two new food and beverage products for 7-Eleven customers. The companies are debuting Doritos Loaded and Mtn Dew Solar Flare, an exclusive flavor for 7-Eleven's Big Gulp beverages.

Doritos Loaded is triangular in shape and is filled with melted cheese and encrusted with Doritos Nacho Cheese flavor. The product will cost $1.99 for a box of four.

"Doritos Loaded is a never-been-done-before, bold experience with a crunch and, particularly when paired with the intense flavor of Mtn Dew Solar Flare, creates the kind of snack I think our guests will love," said Nancy Smith, 7-Eleven senior VP of fresh foods and proprietary beverages. "Today, we are bringing these exclusive products to the rest of the country."

McCain Foods, a supplier of snack food and potato products for the foodservice industry, will manufacture Doritos Loaded.

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Kansas City’s HCA Midwest Health System, Walgreens partner on collaborative care model

BY Michael Johnsen

KANSAS CITY, Mo. – HCA Midwest Health System, a healthcare provider here, and Walgreens on Tuesday announced a collaboration that will provide coordinated and expanded healthcare services for area residents, while enhancing access to high-quality, convenient and affordable care for patients.
 
“We are pleased to partner with Healthcare Clinic at select Walgreens, knowing that this collaboration extends quality care directly into our communities to provide greater access options for patients,” said M.L. Lagarde III, president, HCA Midwest Health System. “We have all experienced the inconvenience of getting sick during the night or on weekends when the doctor’s office is closed. Through our relationship with Walgreens, we are able to provide HCA Midwest Health System patients a more comprehensive continuum of care, ensuring that patients are provided the right level of care, close to where they live, work and play."
 
According to Darryl Nelson, chief medical officer, HCA Midwest Health System, another important benefit is that Healthcare Clinic at select Walgreens will complement HCA Midwest Health System’s robust physician network, urgent care and other facilities, acting as a treatment point for non-emergency situations.
 
The collaboration will include access to coordinated care through Kansas City metro area Healthcare Clinics at select Walgreens. Working with Walgreens, HCA Midwest Health System patients have added convenient, walk-in care options including care for minor injuries or illnesses, health testing and screening and support when their physicians’ offices may be closed, including after-hours and weekends, or when an Emergency Room visit is not required.
 
While Walgreens encourages all patients to have a designated primary care physician and medical home for ongoing needs, Healthcare Clinics at select Walgreens staff nurse practitioners who can write prescriptions and administer immunizations. Direct communication between Healthcare Clinic nurse practitioners and HCA Midwest physicians can enable ongoing coordinated patient care.
 
“There truly is no substitute for an individual’s physician,” Nelson said. “What happens is that many patients view the emergency room as the only viable option for medical care in the evening, [during] the weekend or other times when the doctor's office may be closed, often resulting in higher costs for patients. ER’s are frequently crowded with ‘non-emergency’ patients who could be treated less expensively elsewhere. Healthcare Clinic nurse practitioners are skilled at quickly evaluating conditions, then treating or referring the patient to the appropriate next step, which can include physician follow-up, urgent care or the ER," he said. "Additionally, and with patient consent, Walgreens will be able to share information [with] their HCA Midwest Health System physician to provide a seamless and efficient plan of care, benefitting all parties."
 
HCA Midwest Health System — with seven hospitals, multiple urgent care and outpatient facilities, more than 450 providers and 145 physician office locations — provides care within the greater Kansas City region. 
 

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