Archives for April 2016

FDA Drafts Drug Compounding Guidance for Health-System Pharmacies

The FDA has issued 3 draft guidance documents that clarify how it intends to enforce the prescription requirement for drugs compounded by health-system pharmacies.
Currently, under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), compounding pharmacies that aren’t registered outsourcing facilities must obtain a valid prescription order prior to compounding any drug products. If the draft guidance documents are finalized, however, the FDA wouldn’t take action against a hospital pharmacy that distributes compounded drugs without first receiving a patient-specific prescription, provided that all of the following provisions are met:
1.     The drug products are distributed only to health care facilities that are owned and controlled by the same entity that owns and controls the hospital pharmacy and that are located within a 1-mile radius of the compounding pharmacy.
2.     The drug products are only administered within the health care facilities to patients within the health care facilities, pursuant to a patient-specific prescription.
3.     The drug products are compounded in accordance with all other provisions of Section 503A, and any other applicable requirements of the FDAC and FDA regulations.
One immediate issue with the proposed rules is that hospital pharmacies lacking patient-specific prescriptions would be unable to furnish compounded drugs to satellite locations more than 1 mile away, regardless of whether they’re part of the same campus.
The FDA acknowledged in its guidance that hospitals have a legitimate need for “office stock” of certain compounded medications for use in situations where a patient may need the drug more quickly than it can be produced. However, the agency suggested that such medications could be compounded in registered outsourcing facilities that don’t require a prescription.
“Hospitals, clinics, and health care practitioners can obtain non-patient-specific compounded drug products from outsourcing facilities registered under Section 503B,” noted the proposed guidance for prescription requirements. “Outsourcing facilities, which are subject to [Current Good Manufacturing Practice] requirements, FDA inspections according to a risk-based schedule, specific adverse event reporting requirements, and other conditions that provide greater assurance of the quality of their compounded drug products, may, but need not, obtain prescriptions for identified individual patients prior to distribution of compounded drug products.”
Critics of the guidance have said that the proposed policies overstep state pharmacy board regulations and may curtail patients’ access to the tailored drugs they need.
Just days after the documents were released, the House Committee on Appropriations released a draft report criticizing the FDA’s hardline stance.
“The committee reminds the FDA that compounding pharmacies are not drug manufacturers, but rather are state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states,” the committee’s report read.
Compounded drugs can play an important role in the care of patients whose clinical needs can’t be met by FDA-approved products, including those who require a liquid formulation of a drug that is otherwise only available as a tablet. However, compounded drugs can pose greater risk to patients than FDA-approved products because they lack premarket review for safety, effectiveness, and quality.
These products have faced much scrutiny in the wake of the 2013 incident involving contaminated steroid injections compounded at the New England Compounding Center. This event caused serious infections and other injuries across at least 751 patients and also resulted in at least 64 patient deaths.
The FDA’s trio of guidance documents come a little over a year after the agency issued 5 draft documentsconcerning compounding regulations.

Bristol-Myers Squibb cancer drug receives expedited FDA status

Bristol-Myers Squibb Company BMY, -0.89% said early Monday that the Food and Drug Administration would expedite the development and review of its head and neck cancer drug Opdivo on the strength of its phase 3 trial results. Opdivo, which received the special status for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck after therapy, also previously got the designation for the purposes of Hodgkin lymphoma, previously treated advanced melanoma, previously treated non-squamous non-small cell lung cancer and advanced or metastatic renal cell carcinoma. According to Bristol-Myers Squibb, nearly all of head-and-neck cancers are classified as squamous cell carcinoma. The company’s stock was up 0.5% in pre-market trade.

FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding

If you read one thing…

  • FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before distributing compounded drugs to a hospital, clinic or other health care facility.


Robotic Compounding Of Medications Helps Improve Patient Safety

Using robotic systems for sterile IV therapies improves safety and compliance, reduces waste.

IV compounding, particularly around chemotherapy drugs, poses a safety hazard to employees if ideal policies aren’t followed consistently. This is particularly difficult even as industry experts have yet to develop what these requirements should be. Automating this process simplifies workflows, minimizes employee exposure to potentially dangerous materials, and supports improved care for oncology patients by eliminating medication errors.

Three New FDA Draft Guidance Documents for Drug Compounders

On Friday, the US Food and Drug Administration (FDA) released three draft guidance documents for drug compounders.

The guidance describes FDA’s interpretation of the prescription requirement in section 503A of the Food Drugs & Cosmetics Act (FD&C Act), how the agency intends to apply such a requirement to compounding for hospitals or health system pharmacies, and the definition of the term “facility,” in reference to section 503B of the FD&C Act.

Safety issues at compounding pharmacy underscore oversight problems

In March FDA issued a health alert recommending that doctors and patients should toss sterile medicines made by the Texas compounder IV Specialty. The agency found numerous safety issues during an inspection earlier this year, but IV Specialty refused an agency recommendation to halt production or issue a recall until the problems were fixed. FDA, which is not aware of any adverse events attributed to the drugs, lacks authority to force the compounder to take these steps. Meanwhile, though, the medicines, which are injected or infused, remain available. In early April, the consumer advocacy group Public Citizen urged the Texas State Board of Pharmacy to suspend the compounder’s license. However, the Texas State Board of Pharmacy is declining to do so. In response to the FDA actions, the state agency sent its own inspector to review IV Specialty facilities. But “our inspector was comfortable that there wasn’t an immediate danger to the public,” said Gay Dodson, the board’s executive director. “According to our rules, they’re doing what they need to do. We didn’t see anything that we felt would prompt us to immediately close them down.” The incident underscores the unsettled approach to government oversight of compounders.
STAT News (04/08/16) Silverman, Ed
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The importance of first air in aseptic processing and sterile compounding

“First air is the last defense against contamination.” It can help guard against bad technique being utilized in upstream processes. The USP goes to great lengths to describe first air and unidirectional airflow. Significant testing and airflow characteristic patterning is also routinely done in the pharmaceutical manufacturing segment. It is tremendously important when set against potential drug contamination.

FDA: 2 Diabetes Drugs May Be Linked to Heart Failure Risk

(HealthDay News) — Diabetes drugs containing saxagliptin and alogliptin may raise the risk of heart failure, particularly in patients with heart or kidney disease, U.S. health officials warned Tuesday.

FDA warns about sterile drug products from Medaus Pharmacy

A lack of sterility assurance has prompted FDA to warn patients and health care providers not to use unexpired drug products that are intended to be sterile from Medaus Pharmacy. A recent inspection of the Birmingham, AL company’s facility revealed insanitary conditions, including poor sterile production practices.
A lack of sterility assurance has prompted FDA to warn patients and health care providers not to use unexpired drug products that are intended to be sterile from Medaus Pharmacy. A recent inspection of the Birmingham, AL company’s facility revealed insanitary conditions, including poor sterile production practices. Medaus was ordered by the Alabama Board of Pharmacy to halt sterile compounding operations on March 22. One week later, FDA recommended that the company recall all unexpired drug products that are intended to be sterile. Thus far, Medaus has not yet voluntarily recalled any drug products intended to be sterile, prompting FDA’s warning about the products. So far, FDA has not received any reports of adverse events associated with Medaus products.
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FDA: Abortion pill can be used later in pregnancy

Prior guideline was to only use pill up to 49 days into pregnancy

The new FDA-approved regime on the abortion pill was welcomed Wednesday by abortion rights groups who say the drug expands options for women but was criticized by opponents who assert serious risks remain.