503B Compounding Pharmacy

They may still suggest revisions to latest standards but must prepare regardless for new compounding regulations.

For a current compounder or someone looking to enter the space, it is imperative that their business remains on top of the latest compounding developments.

USP General Chapter , which was published by the United States Pharmacopeial Convention and updated most recently in December 2017, sets forth guidelines for the handling of hazardous drugs in the health care setting with the goal of promoting safety for patients and health care workers.

According to the indictment, from May 2014 to September 2016, the involved parties allegedly recieved kickbacks for the referral of TRICARE and DOL beneficiaries to obtain expensive compound drugs.

The FDA is taking new steps to better ensure the quality of compounded drugs, while also preserving patient access to these medications.

USP Chapter presents many challenges for pharmacies and other health care settings, especially compounding pharmacies.

United States Pharmacopeial Convention (USP) Chapter has many prerequisites for personal protective equipment

Top news of the day from across the health care landscape

At the American Pharmacy Purchasing Alliance’s PharmCon in Orlando, FL, experts with collaborative practice experience discussed why these pharmacist-physician partnerships are useful, and how they can effectively work.

In this clip, Fred Massoomi, PharmD, FASHP, Senior Director at Visante, offers advice on the best practices for USP 800 compliance, including gap analysis, individual monitoring, and education.

In this clip, Dennis Killian, PharmD, PhD, Director of Pharmacy at Peninsula Regional Medical Center, compares the use of premixed with compound IV products for enhanced patient safety.

In this clip, Dennis Killian, PharmD, PhD, Director of Pharmacy at Peninsula Regional Medical Center, discusses the features and functionalities to consider when purchasing a new infusion pump.

Dennis Killian, PharmD, PhD, Director of Pharmacy at Peninsula Regional Medical Center, talks about the benefits of using ready-to-use, premixed IV products versus compound IV products.

Our team is on site in Denver all week covering from ASHP Summer 2018.

Designed with exclusive new features for bidirectional electronic medical records integration.

In response to the numerous concerns regarding antineoplastic drugs and other medications that may threaten the health of patients and health care workers, the National Institute for Occupational Safety and Health (NIOSH) developed a list, updated biennially, of hazardous drugs.

The pharmacist-in-charge was out of town, but an order came in for a compounded chemotherapy medication that was needed the same day, so he authorized a technician to prepare it with no pharmacist present to supervise.

Each year, more than 8 million U.S. health care personnel are potentially exposed to hazardous medications. Acute and chronic health effects have been reported, including headaches, ocular problems, rashes, hair loss, adverse reproductive health, and increased cancer risk.

Officials with the FDA have issued 2 final guidance documents to help implement the 2018 Compounding Policy Priorities Plan, which explain the agency’s policies on the “essentially a copy” provisions of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

Priority areas that pharmacists should focus on ahead of USP .

To prepare for USP Chapter , pharmacies must ensure that they are meeting the right compounding compliance standards.

Pharmacists should be aware of what components they need to address to comply in order to prep themselves for USP standards.

When approaching a plan for handling hazardous drugs, leaders of each organization need to be proactive in complying with USP regulations.

In this clip, Jennifer Bruckart, CPhT, Director of Operations and Compliance at WeCare Pharmacy, discusses how community pharmacists can prepare for the new USP 800 regulations.