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FDA Releases Draft Guidance for 503B Compounding Facilities
December 11, 2018

To read the draft: Click Here


Should you Build a 503B Compounding Facility?
December 7, 2018
Ernest R. Anderson Jr., RPh, MS, the author of “Leadership in Action,” talks with Matthew Brown, PharmD, MLSASCP, the pharmacy manager of the Compounding Pharmacy at Duke University Health System Raleigh-Durham, North Carolina, about the 503B facility that Duke operates.

To watch the videos: Click Here


Five Reasons To Consider Outsourcing Analytical Testing
November, 2018
Defining what you do best as a company, where you add the most value, and conversely, areas of lower efficiency can be a productive route to greater profitability. For manufacturers, analytical testing is essential, from R&D through to QC, but it is not a primary output and often not a core competency. This raises the question of how much in-house analysis is optimal.

To read the full white paper: Click Here


FDA’s Regulatory Actions for 503B Compounders
September, 2018
Managing a health system pharmacy in today’s complex regulatory environment can be a daunting task. Drug shortages, recalls, and unreliable medication availability is just a few of the concerns that must be addressed on a daily basis. Outsourcing compounded sterile preparations (CSPs) is a commonly utilized strategy to address product reliability issues.

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FDA to Remove APIs from list
September 10, 2018
On August 28, 2018, the FDA published a federal register notice of their intent to remove 3 active ingredients (Bumetanide, Nicardipine HCl, and Vasopressin) from the List of Bulk Drug Substances that can be used to compound drug products under 503B of the FD&C Act.  Their stated reasons are, (1) a lack of evidence of clinical need and (2) availability of a commercial alternative which can be used to produce compounds.

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18.7M pills lost due to healthcare employee misuse and theft
September 10, 2018
The first half of 2018 proved that clinical drug diversion continues to threaten the ability of healthcare organizations to provide high-quality patient care and to ensure safe medication administration.

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Eastern District of Michigan Announces Record Setting Hospital Drug Diversion Penalty Settlement with the University of Michigan Health System
August 30, 2018
The United States Attorney’s Office for the Eastern District of Michigan announced today that the University of Michigan Health System (UMHS) has agreed to pay the United States $4.3 million as part of a settlement resolving allegations that UMHS violated certain provisions of the Controlled Substances Act (CSA), 21 U.S.C. §§ 801-904.

To read the full release: Click Here


FDA Announces New Drug Shortages Task Force
August 21, 2018
The FDA has announced the formation of a drug shortages task force, which the agency said will address some of the underlying structural concerns that give rise to the recurring supply disruptions that have put such a severe burden on pharmacy operations and patient care.

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FDA And Quality Metrics: Where Do Things (Currently) Stand?
July 27, 2018
Are you ready to give the FDA more? “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no.

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FDA Bulk Drug List for 503B Facilities
July 23, 2018
Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.

Click Here to Download


Quality Risk Management 101: Overcoming Common Challenges In QRM Implementation
June 27, 2018
This article explores challenges with QRM implementation that are shared by many within the industry.

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Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture
June 18, 2018
Shortcomings in data governance and data integrity are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services including contract manufacture and contract laboratories.

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Rethinking The Role Of Packaging Design In Drug Development
June 6, 2018
Packaging is an important component in the development of various drugs, as it can greatly affect drug stability and safety.

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Pharmacists Can Struggle With Substance Use Disorder
May 11, 2018
Substance use disorders are related to alcohol, tobacco, cannabis, stimulants, hallucinogens, and opioids. Terms such as ‘abuse’ and ‘dependence’ are no longer used to describe the condition…

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Someone, Everyone, Or No One: Who Owns Quality? (And Who Should)
May 7, 2018
Who is ultimately responsible for quality/the quality management system?

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Hospital Staff With Addictions Stealing Drugs
February 3, 2018
When healthcare workers steal the medication prescribed to patients to feed an addiction, the consequences can be catastrophic. W5 investigates the silent epidemic of ‘drug diversion.’

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Microbial Expectations For 503B Compounding Pharmacies
January 22, 2018
The Drug Quality and Security Act of 2013 includes a category of compounders known as outsourcing facilities. According to section 503B of the Food Drug and Cosmetic Act (FD&C Act), outsourcing facilities are required to comply with all current good manufacturing practices (cGMPs) and regulations regarding insanitary conditions.

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FDA Plans More Restrictive Policy for Bulk Drug Compounding
January 18, 2018
The head of the U.S. Food and Drug Administration on Thursday said it is preparing a new, more restrictive policy targeting what drugs compounding pharmacies can produce that do not go through the agency’s approval process.

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2018 Compounding Policy Priorities Plan
January 2018
This plan provides an overview of the key priorities our agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission.

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FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
November 30, 2017
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for moderate-to-severe opioid use disorder.

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How Opioids Started Killing Americans
November 29, 2017
More than half of all people who succumbed to an overdose between 2001 to 2007 were chronic pain sufferers who filled an opioid prescription and sometimes even saw a doctor in the month before they died. Only 4 percent were ever diagnosed as having an abuse problem, said Dr. Mark Olfson, one of five researchers who conducted a massive study of the crisis and its causes for Columbia University Medical Center.

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Too Difficult; You’ll Fail – The Difficult to Compound List
November 6, 2017
There’s an initiative that’s been underway, for both 503A and B’s abilities to be limited. If you’re not aware of the “difficult to compound” list and you’re a compounder, get out a paper and pen because you’ll want to take some notes. This most recent list has been around more or less since 2000, when the Pharmacy Compounding Advisory Committee submitted it to the FDA for consideration. The list included drugs and methods that prove to be “demonstrably difficult” to compound; ones that are so difficult that small compounding pharmacies shouldn’t attempt. 

To read the full article: Click Here


CDC tells Opioid Addiction Stories with Message: ‘It Only Takes a Little to Lose a Lot’
November 3, 2017
The Centers for Disease Control and Prevention is telling the personal stories of people who were addicted or knew someone who was addicted to prescription opioids in a new campaign called Rx Awareness.
The stories will be told through videos, radio spots, and social media, with the message that prescription opioids can be addictive and “it only takes a little to lose a lot.”

To read the full article: Click Here


What is Amazon Doing in Health and the Pharmacy Industry?
October 31, 2017

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Biocontainment: An Introduction to Control Levels & Practical Design Concepts
September 4, 2017
In part 1 of our article on biocontainment, we discussed the history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We also discussed the regulatory regime for biological agents and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.

To read the full article: Click Here


State of Serialization: Where FDA & The Pharma Industry Currently Stand
September 1, 2017
Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually. A bigger issue for consumers, however, is that falsely labeled medicines can have a direct impact on life and health.

To read the full article: Click Here