Friday, October 15, 2021

 

Wednesday, October 6, 2021

 

FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs The following is attributed to Donald D. Ashley, J.D., director of the Office of Compliance in the FDA's Center for Drug Evaluation and

 



Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our efforts to help preserve access to compounded drugs for patients who have a medical need for them.   

We understand that compounded drugs can serve an important role for patients in hospitals and other healthcare settings whose medical needs cannot be met by an FDA-approved product, and that hospital care raises unique considerations and needs. Recognizing this, in 2016 the agency proposed a policy in draft guidancethat described certain flexibilities for hospital and health system pharmacies that distribute compounded drugs within their health system before receiving patient-specific prescriptions.  

Since that time, the agency has received many comments on this proposed policy, including regarding a provision about FDA’s intent not to take action if a hospital or health system pharmacy distributes compounded drugs to healthcare facilities within a one-mile radius, that are owned and controlled by the same entity that owns and controls the pharmacy. Stakeholders commented that the proposed one-mile policy was not reflective of the structure of health systems, many of which operate under a centralized compounding model and may service facilities at other sites located outside a one-mile radius without similar compounding capabilities. 

After considering these comments, to help preserve access to compounded drugs, today, the FDA is revising our draft guidance to, among other things, remove the one-mile radius provision. We are proposing a two-part compliance policy.  The policy describes circumstances under which the agency generally does not intend to take action against a hospital or health system pharmacy, that is not an outsourcing facility, that compounds and distributes a drug without first receiving a valid prescription or order for an individual patient. These circumstances include that compounded drugs be administered only to patients within the hospital or health system and the drugs are used or discarded within 24 hours of leaving the pharmacy. 

With respect to hospital and health system pharmacies that deviate from these circumstances, the revised draft guidance outlines the FDA’s intention to take a risk-based approach to enforcement. Hospital and health system pharmacies can measure their operations against certain factors to assess whether their practices are likely to be an enforcement priority. At this time and based on the agency’s current understanding of the risks, the FDA generally intends to consider the following factors for prioritizing risk-based regulatory action:  

  • poor compounding practices or a lack of sterility assurance
  • non-patient-specific compounded drugs that are not for emergency uses
  • routine, large amounts of non-patient-specific compounded drugs
  • interstate distribution of large amounts of non-patient-specific compounded drugs
  • lack of a procedure to obtain non-patient-specific compounded drugs from an outsourcing facility. 

Hospitals and health systems have varying distribution practices for drugs that have been compounded in their pharmacies. The agency understands the size of operations and resources available to hospital and health system pharmacies varies widely. For example, small rural hospitals may differ from large multi-state health systems. Some pharmacies compound drugs only for use in the same hospital where the pharmacy is located, (e.g., for the treatment of patients during a hospital admission, or for use in the hospital emergency room). Other health system pharmacies distribute compounded drugs to other facilities within their health system, such as to other hospitals, clinics, infusion centers or long-term care facilities within the health system.  

While the revised draft guidance provides additional flexibility, the agency encourages hospitals and health systems to have procedures in place to obtain non-patient-specific compounded drugs from outsourcing facilities and to consider registering their pharmacies as outsourcing facilities. 

We believe the revised policy being proposed today will assist hospitals and health systems in their approach to appropriate medical treatments for patients. The agency will further consider the policy based on any comments received in response to this revised draft guidance before it is finalized. The FDA remains committed to our compounding policy efforts as we continue to promote opportunities to improve health and provide appropriate medications for patients who rely on compounded drugs.  


https://www.fda.gov/news-events/press-announcements/fda-revises-hospital-and-health-system-compounding-guidance-help-preserve-patient-access-compounded?utm_medium=email&utm_source=govdelivery

Thursday, September 30, 2021

 

1 day ago — A Puerto Rico pharmacist has pleaded guilty to administering Pfizer's COVID-19 vaccine (Comirnaty) to children younger than 12, the Justice Department ...

 

4 days ago — Professional Compounding Centers of America (PCCA) is an independent compounding pharmacist's complete resource for fine chemicals, equipment, ...
Founded: 1981
Revenue: $25 to $50 million (USD)
Size: 201 to 500 Employees
Headquarters: Houston, TX
 Rating: 3.1 · ‎49 votes

 

5 days ago — Another great reason for having more compound pharmacies available is having skilled pharmacists make this possible. They make the use of natural ingredients 

 

3 days ago — CONCERNING THE ABILITY OF A PRESCRIPTION DRUG OUTLET TO. 101. COMPOUND DRUGS FOR ... distribute compounded drugs to a hospital located in Colorado.

 

3 days ago — But NECC was actually processing compounded medication orders for ... FDA as to whether NECC was a drug manufacturer or a compounding center because the law ...

 Department of Justice

U.S. Attorney’s Office
Eastern District of Louisiana

FOR IMMEDIATE RELEASE
Tuesday, September 28, 2021

Two Plead Guilty to Health Care Fraud Scheme

NEW ORLEANS - U.S. Attorney Duane A. Evans announced DONALD PETER AUZINE (“AUZINE”) and BONNIE JEAN LAWLESS DIAZ (“DIAZ”) have each pled guilty in federal court relating to their roles in a health care fraud conspiracy.

AUZINE, age 51, a resident of Baton Rouge, Louisiana, pled guilty on September 23, 2021 before U.S. District Judge Jay C. Zainey to Count One of an Indictment charging him with conspiracy to commit health care fraud, in violation of Title 18, United States Code, Sections 1347 and 1349.

DIAZ, age 46, a resident of Slidell, Louisiana, pled guilty on September 23, 2021 before U.S. District Judge Jay C. Zainey to Count One of a Superseding Bill of Information charging her with misprision (or knowing concealment) of the commission of a felony, in violation of Title 18, United States Code, Section 4.

According to the Indictment, in or around March 2014, continuing through in or around October 2016, AUZINE, conspired to knowingly and willfully execute a scheme and artifice to defraud TRICARE, a federal health care benefit program affecting commerce, and other health care benefit programs.

AUZINE was the marketing manager of Prime Pharmacy Solutions (“Prime”), which was located in Slidell, Louisiana. Prime Pharmacy was primarily a closed-door pharmacy whose primary business focus was the production of compounded medication, which, when created properly, were drugs combined, mixed, or altered by licensed pharmacists or other practitioners to meet the specialized needs of individual patients. The Pharmacist-in-Charge (“PIC”) was responsible for supervision, management, and compliance with all federal and state pharmacy laws and regulations pertaining to Prime Pharmacy’s pharmacy practice.

The owner, on behalf of Prime Pharmacy, contracted with various entities, including Pharmacy Benefit Managers (“PBMs”), obligating Prime Pharmacy to collect copayments from beneficiaries in order to be reimbursed by various health care benefit programs, including TRICARE. Additionally, the owner of Prime worked with AUZINE to market the compounded medications produced by Prime Pharmacy. AUZINE found other marketers outside of the state to find beneficiaries that were willing to receive medically unnecessary compounds and doctors willing to prescribe compounds without medical necessity.

AUZINE would pressure the pharmacists to fill prescriptions for beneficiaries where no doctor-patient relationship existed. He also aided in the creation of the prescription pads that had the highest value prescription

Beginning in or around March 2014, and continuing through in or around April 2016, Prime Pharmacy dispensed prescriptions for High-Yield Compounded Medications to beneficiaries of TRICARE and other health care benefit programs that were not medically necessary, induced by kickback payments, or where copayments were either waived or credited by Prime Pharmacy, and accordingly, submitted or caused to be submitted false and fraudulent claims for reimbursement to TRICARE, other health care benefit programs, and PBMs.

AUZINE received a percentage of Prime Pharmacy’s profits, including a percentage of the reimbursements paid by TRICARE and other health care benefit programs procured through fraud.

According to the Superseding Bill of Information, DIAZ had knowledge of the commission of the health care fraud. DIAZ concealed the fraud by knowingly submitting or caused to be submitted compounded medications for which there was no medical necessity and did not as soon as possible make known the same to some judge or other person in civil or military authority under the United States.

“Individuals involved in this scheme illegally billed TRICARE out of close to $15 million and I am pleased that the U.S. Attorney’s Office is requiring justice,” said Special Agent in Charge Cynthia Bruce, Defense Criminal Investigative Service, Southeast Field Office.  “There are no victimless crimes and DCIS agents will continue to pursue unscrupulous greedy individuals who steal from our military health care system and all taxpayers."

The Court set sentencing of AUZINE and DIAZ for January 4, 2022.

AUZINE faces a maximum term of imprisonment of ten years, a $250,000 fine, three (3) years supervised release, a $100 special assessment fee, and restitution in the amount of $1.2 million.

DIAZ faces a maximum term of imprisonment of three years, a $250,000 fine, up to one  (1) year of supervised release following any term of imprisonment, a $100 special assessment fee, and restitution in the amount of $180,000.

The U.S. Attorney’s Office praised the work of the Defense Criminal Investigative Service – Office of Inspector General, the Department of Homeland Security, the Department of Veterans Affairs – Office of Inspector General, and the United States Postal Service – Office of Inspector General. 

The prosecution of the case is being handled by Assistant United States Attorney Kathryn McHugh.