Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, February 24, 2022
Wednesday, February 23, 2022
| Smart Surgical, Inc dba Burst Biologics | Office of Biological Products Operations – Division 2 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | ||||
| Extrapharmacy.ru | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet | ||||
| rxshopmd.com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet | ||||
| CytoDyn, Inc. | The Office of Prescription Drug Promotion (OPDP) | New Drug/Labeling/Misbranded | ||||
| Toxikon Corporation/Labcorp Bedford LLC | Center for Biologics Evaluation and Research | Good Laboratory Practice (GLP) |
Tuesday, February 22, 2022
And on a unrelated but important topic---
- On Feb. 18, the FDA alerted the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated. The FDA worked with the company to initiate a voluntary recall of the affected products.
- On Feb. 11, as part of the FDA’s effort to protect consumers, the agency issued a warning letter to CytoDyn Inc. for making representations in a promotional context that leronlimab, a drug that has not been approved or authorized by the FDA, is safe and effective for use in treating COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- On Feb. 15, as part of the FDA’s effort to protect consumers, the agency issued warning letters to operators of two websites, https://extrapharmacy.ru/ and https://www.rxshopmd.com/ for marketing unapproved and misbranded drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider. to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
Prescription Labs DBA Greenpark Compounding Pharmacy
Houston, TXEffective immediately, Prescription Labs DBA Greenpark Compounding Pharmacy, an unlicensed nonresident pharmacy and an unlicensed sterile compounding pharmacy shall CEASE AND DESIST practicing any activity that requires licensure, including compounding sterile drug products for shipment into California, and shipping, mailing, or delivering, in any manner, controlled substances and dangerous drugs into California.
Effective December 8, 2021
View Immediate Protection Order
Burbank Tower Pharmacy, PHY 53938, Administrative Case AC 7154
Burbank, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered. The surrender shall be stayed for ninety (90) days from the effective date of the decision, namely April 19, 2022, at which time the pharmacy shall be sold or closed.
Decision effective 1/19/2022.
Drug Depot, PHY 50418, Administrative Case AC 6796
Montebello, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered. The surrender shall be stayed until May 5, 2022, at which time the pharmacy shall be sold or closed.
Decision effective 01/05/2022.
Infuserve America Inc., NRP 928, Administrative Case AC 7060
Saint Petersburg, FL
Through a disciplinary action of the Board, the license is publicly reproved subject to the terms and conditions in the decision.
Decision effective 01/19/2022.
Infuserve America Inc., NSC 99521, Administrative Case AC 7060
Saint Petersburg, FL
Through a disciplinary action of the Board, the license is publicly reproved subject to the terms and conditions in the decision.
Decision effective 01/19/2022.
Remedy Drugs, PHY 42129, Administrative Case AC 6951
Glendale, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered. The surrender shall be stayed until May 5, 2022 at which time the pharmacy shall be sold or closed.
Decision effective 1/5/2022.
Ten Pharmacy, PHY 53619, Administrative Case AC 6796
Long Beach, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 01/05/2022.
Tower Pharmacy, PHY 53607, Administrative Case AC 7035
Burbank, CA
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 1/19/2022.
University of California Irvine Medical Center, HPE 49819, Administrative Case AC 6997
Orange, CA
Through a disciplinary action of the Board, the license shall be subject to public reproval and subject to terms and conditions in the decision.
Decision effective 01/05/2022.
University of California Irvine Medical Center, LSE 100230, Administrative Case AC 6997
Orange, CA
Through a disciplinary action of the Board, the license shall be subject to public reproval and subject to terms and conditions in the decision.
Decision effective 01/05/2022.
quoted from Disciplinary Actions for January 1, 2022 - March 31, 2022 - California State Board of Pharmacy
Orinda Rx & Medical LLC., Applicant, Statement of Issues Case SI 7199
Orinda, CAStatement of Issues Filed 12/7/2021; Case pending.
View Accusation
Friday, February 18, 2022
Thursday, February 17, 2022
Isn't it Time for Congress to Hold Hearings on the Compounding Pain Cream Scheme and Investigate How Such a Massive Health Care Fraud Was Accomplished By So Many People Involving Various Insurances Including Federal Insurance Programs Such as Tricare and To Prevent Such Fraud Involving Compounded Medications Happen Again? When will the question of who came up with the original idea and who was the spoke in this wheel conspiracy with all these coconspirators be answered?.
Department of Justice
U.S. Attorney’s Office
Northern District of Oklahoma
FOR IMMEDIATE RELEASE
Wednesday, February 16, 2022
Doctor Pleads Guilty to Accepting Illegal Kickback Payment in Return for Writing Prescriptions for Compounded Drugs
A doctor licensed in the states of Oklahoma and Texas pleaded guilty Wednesday for writing and referring compounded drug prescriptions in return for illegal kickback payments, announced U.S. Attorney Clint Johnson.
Jerry May Keepers, 68, of Kingwood, Texas, pleaded guilty to one count of soliciting and receiving heath care kickback. Keepers violated the federal anti-kickback statute when he accepted the illegal payment.
If the plea agreement is accepted by U.S. District Judge Claire V. Eagan, Keepers will serve 36 months of supervised probation and pay no more than $1,518,180.46 in restitution. Judge Eagan will sentence Keepers on May 10, 2022.
In the plea agreement, Keepers admitted that OK Compounding solicited him to write prescriptions for his patients that would be filled by the pharmacy. OK Compounding was a pharmacy controlled by Christopher Parks and Dr. Gary Lee, who are also defendants in the case.
Specifically, on January 22, 2014, Keepers knowingly received $25,000 from representatives of OK Compounding. The purpose of the payment was to induce Keepers to refer prescriptions for expensive compounded drugs to the pharmacy. The compounded medications were filled, and claims were filed by the pharmacy. Those medications were in turn paid for by federal healthcare programs, including TRICARE, Medicare, CHAMPVA, and the Federal Employees Compensation Act Program.
According to the superseding indictment filed in the case, kickback payments were disguised through various sham business arrangements, including contracts where several physicians purported to serve as “medical directors” or “consulting physicians” for the pharmacy. Keepers and OK Compounding represented that Keepers had been paid for his services as a national spokesperson, medical director or national marketing director.
It is illegal to pay or receive “kickbacks” in conjunction with federal health care insurance. Prohibitions against kickbacks are crucial to ensure that financial motives do not undermine the medical judgment of physicians and other health care providers.
Keepers ran a pain clinic practice in the cities of Friendswood, Beaumont and Humble, Texas, and established a clinic in Tulsa in November 2012.
The Department of Labor- Office of Inspector General (OIG), IRS - Criminal Investigation, U.S. Postal Service- OIG, Department of Veterans Affairs- OIG, FBI, the Department of Health and Human Services-OIG, and Defense Criminal Investigative Service conducted the investigation. Assistant U.S. Attorneys Melody Noble Nelson and Richard M. Cella are prosecuting the cases.
Topic(s):
Health Care Fraud
Component(s):
quoted from https://www.justice.gov/usao-ndok/pr/doctor-pleads-guilty-accepting-illegal-kickback-payment-return-writing-prescriptions
Contact:
Public Affairs
918-382-2755
A doctor licensed in the states of Oklahoma and Texas pleaded guilty Wednesday for writing and referring compounded drug prescriptions to OK Compounding in return for illegal kickback payments, announced U.S. Attorney Clint Johnson.
Date: February 16, 2022
Contact: newsroom@ci.irs.gov
A doctor licensed in the states of Oklahoma and Texas pleaded guilty Wednesday for writing and referring compounded drug prescriptions in return for illegal kickback payments, announced U.S. Attorney Clint Johnson.
Jerry May Keepers of Kingwood, Texas, pleaded guilty to one count of soliciting and receiving heath care kickback. Keepers violated the federal anti-kickback statute when he accepted the illegal payment.
If the plea agreement is accepted by U.S. District Judge Claire V. Eagan, Keepers will serve 36 months of supervised probation and pay no more than $1,518,180.46 in restitution. Judge Eagan will sentence Keepers on May 10, 2022.
In the plea agreement, Keepers admitted that OK Compounding solicited him to write prescriptions for his patients that would be filled by the pharmacy. OK Compounding was a pharmacy controlled by Christopher Parks and Dr. Gary Lee, who are also defendants in the case.
Specifically, on January 22, 2014, Keepers knowingly received $25,000 from representatives of OK Compounding. The purpose of the payment was to induce Keepers to refer prescriptions for expensive compounded drugs to the pharmacy. The compounded medications were filled, and claims were filed by the pharmacy. Those medications were in turn paid for by federal healthcare programs, including TRICARE, Medicare, CHAMPVA, and the Federal Employees Compensation Act Program.
According to the superseding indictment filed in the case, kickback payments were disguised through various sham business arrangements, including contracts where several physicians purported to serve as "medical directors" or "consulting physicians" for the pharmacy. Keepers and OK Compounding represented that Keepers had been paid for his services as a national spokesperson, medical director or national marketing director.
It is illegal to pay or receive "kickbacks" in conjunction with federal health care insurance. Prohibitions against kickbacks are crucial to ensure that financial motives do not undermine the medical judgment of physicians and other health care providers.
Keepers ran a pain clinic practice in the cities of Friendswood, Beaumont and Humble, Texas, and established a clinic in Tulsa in November 2012.
The IRS - Criminal Investigation, Department of Labor- Office of Inspector General (OIG), U.S. Postal Service- OIG, Department of Veterans Affairs- OIG, FBI, the Department of Health and Human Services-OIG, and Defense Criminal Investigative Service conducted the investigation. Assistant U.S. Attorneys Melody Noble Nelson and Richard M. Cella are prosecuting the cases.
quoted from https://www.irs.gov/compliance/criminal-investigation/doctor-pleads-guilty-to-accepting-illegal-kickback-payment-in-return-for-writing-prescriptions-for-compounded-drugs
Extremely High Importance: FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray
February 16, 2022
Background
FDA has become aware of safety reports involving compounded intranasal ketamine to treat psychiatric disorders which may be putting patients at risk. Compounded drugs are not FDA-approved, which means FDA has not evaluated their safety, effectiveness, or quality prior to marketing.
Ketamine hydrochloride[a] (tradename: Ketalar) is a Schedule III controlled substance that is FDA-approved as an intravenous or intramuscular injection solution for induction and maintenance of general anesthesia. Ketamine is a racemic mixture consisting of two mirror image molecules, R- and S-ketamine. FDA-approved labeling for ketamine contains warnings and precautions on hemodynamic instability, emergence reactions (vivid dreams, hallucinations, or delirium), respiratory depression, and drug-induced liver injury, among others.
Ketamine is not FDA-approved for the treatment of any psychiatric disorder. However, the “S” form of ketamine, which is derived from ketamine and known as Spravato (esketamine), is a Schedule III controlled substance that was approved by FDA in 2019 as a nasal spray for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior, in conjunction with an oral antidepressant. Because of the potential risks associated with Spravato (esketamine), including sedation, dissociation, and abuse or misuse, its label contains Boxed Warnings, and Spravato is subject to strict safety controls on dispensing and administration under a safety program called a Risk Evaluation and Mitigation Strategy (REMS). The Spravato REMS[1]program requires Spravato (esketamine) to be dispensed and administered in health care settings that are certified in the REMS. Spravato (esketamine) cannot be dispensed for use outside the certified healthcare setting. Patients must be monitored inside the healthcare setting after administration for a minimum of two hours until patients are safe to leave.
Though esketamine is derived from racemic ketamine, they are not the same drug. Animal studies have shown that racemic ketamine can cause lesions in the brains of rodents;[2] the relevance of this finding to humans is unknown. Animal studies with esketamine do not show these brain lesions.[3]
FDA is aware that some pharmacies compound nasal spray formulations of ketamine either alone or in combination with other ingredients, and there have been a concerning number of case reports of adverse events in recent years. Given these reports and the lack of standardized safety measures associated with the use of compounded ketamine nasal sprays, patients may be at risk of serious adverse events and potential misuse and abuse. FDA is issuing this alert due to the increased awareness of adverse events reported, the seriousness of these adverse events, and the likelihood that adverse events related to compounded drug products are under-reported, given that pharmacies that compound drugs under section 503A generally do not report them.
Case Findings and Discussion
FDA searched the FDA Adverse Event Reporting System (FAERS) database and the medical literature from April 2011 through January 2022 and identified five cases, reported between 2016-2021, associated with psychiatric events such as delusion, dissociation, visual hallucination, and panic attack as well as abuse and misuse[b] following the use of compounded ketamine nasal spray. The reported concentrations of compounded ketamine nasal spray ranged from 125 – 200 mg/mL. Frequency of use varied from three sprays three times a day to six sprays eight times a day. The amount of medication administered to the patients with each spray is unknown. In most case reports, the patients self-administered the product at home, and it is unknown whether they were observed or monitored by a healthcare professional.
Because compounded ketamine nasal spray products are not FDA-approved, there is no FDA-approved dosing regimen for these products. There are also no data to support dosing conversion between Spravato (esketamine) nasal spray and compounded ketamine nasal spray. However, although ketamine is not identical to Spravato, ketamine includes both enantiomers of the molecule, including Spravato’s active ingredient, esketamine. Ketamine and Spravato (esketamine) also share a mechanism of action in that both are N-methyl D-aspartate receptor antagonists. Given these similarities, it is plausible that, in addition to the warnings and precautions associated with FDA-approved ketamine, psychiatric events could be induced or worsened with the use of compounded ketamine nasal spray, especially given the fact that FDA is aware that it is being used at different doses and a higher frequency than are currently approved for Spravato (esketamine). The benefit and risk profile for Spravato (esketamine) has been established, as described in the FDA-approved labeling and the approved Spravato REMS program, with elements to assure safe use. However, the benefit and risk profile for compounded ketamine nasal spray has not been evaluated. As such, FDA has concerns about increased potential risk of adverse events, misuse, and abuse associated with compounded ketamine nasal spray given the apparent different doses, higher frequency of use compared to Spravato (esketamine), and at home administration reported to the FAERS database.
Conclusion
There is no FDA-approved ketamine nasal spray product. Compounded drugs are not FDA-approved, which means FDA has not evaluated their safety, effectiveness, or quality prior to marketing. Therefore, compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. The dispensing of compounded ketamine nasal spray for home use when safe and effective dosing for psychiatric indications has not been established may place the patient at risk for serious psychiatric adverse events, misuse, and abuse. Healthcare professionals should be advised that animal studies have shown an association between racemic ketamine and brain lesions, and that the implications of the animal findings to humans are unknown. FDA recommends that healthcare professionals be aware of the potential risks associated with compounded ketamine nasal spray.
FDA encourages consumers, patients, and health care professionals to report adverse events or quality problems experienced with the use of compounded drugs to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at MedWatch: The FDA Safety Information and Adverse Event Reporting Program; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
[a] The terms “ketamine hydrochloride,” “ketamine,” and “racemic ketamine” are used interchangeably and refer to the same drug product.
[b] FDA defines drug abuse as intentional, nontherapeutic use of a drug product or substance even once, to achieve a desired psychological or physiological effect, and drug misuse as intentional therapeutic use of a drug product in an inappropriate way and specifically excludes the definition of abuse. References: Assessment of Abuse Potential of Drugs – Guidance for Industry; General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products – Guidance for Industry.
References
1 Approved Risk Evaluation and Mitigation Strategies (REMS). Accessed February 8, 2022. Available at Spravato (esketamine).
2 Olney, J. W., Labruyere, J., & Price, M. T. (1989). Pathological changes induced in cerebrocortical neurons by phencyclidine and related drugs. Science, 244(4910), 1360–1362.
3 Drug Approval Package: Spravato (2019). Pharmacology Review(s). Accessed February 8, 2022. Available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000TOC.cfm.
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