Pharm D Solutions LLC is a newcomer to the pharmaceutical industry. FDA records suggest the company has been operating since 2014. The company’s website claims it opened its doors in 2015.
Pharm D Solutions operates as a national compounding pharmacy. According to its marketing materials, it provides hospitals and clinics with “custom batch sizes” of medications and offers lyophilization studies.
According to its website,
- We meet or exceed regulatory requirements issued by state and federal agencies
- We meet or exceed USP 797 requirements for compounded sterile preparations
- We are also registered with FDA as a 503b outsourcing facility. We voluntarily invite the FDA to inspect our facility at random for adherence to Good Manufacturing Practice standards.
- Additionally, our facility is registered with the DEA as a manufacturer, rather than "re-labeler." The requirements for this type of license are far more stringent compared to that of a regular non-sterile compounding pharmacy.
Despite their apparent commitment to quality, recent events suggest real cGMP and sterility problems continue to plague the company.
The FDA inspected Pharm D’s facility during the summer of 2015. According to an FDA warning letter,
“During the inspection, the Investigator observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, the Investigator noted that your firm used non-sterile disinfectants within the aseptic processing areas. In addition, your firm failed to demonstrate through appropriate studies that your hood is able to provide adequate protection of the ISO 5 area in which sterile products are produced. Therefore, your products may be produced in an environment that poses a significant contamination risk.”
The FDA inspection resulted in an FDA 483 letter.
Most pharmaceutical companies take 483 warning seriously and work hard to cure any problems. That doesn’t appear to be the case with Pharm D.
The FDA issued its 483 notice on June 5, 2015. On December 8, 2016 it issued its formal warning letter.
The warning letter says,
“The investigator noted that drug products that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health, causing them to be adulterated... Furthermore, the FDA Investigator observed significant CGMP violations at your facility, causing your drug products to be adulterated…”
Shortly before the FDA warning letter, Pharm D Solutions recalled certain batches of Testosterone cypionate 200 mg/ml in sesame oil and HCG Cyanocobalamin 500 U due to mislabeling. The testosterone recall was widespread and was not limited to a few selected lots.
For a company that claims it opened its doors in 2015, in less than 2 years the company boasted a terrible FDA inspection, 483 warning, a formal warning letter, and two products recalls. Fast forward just a few months and things have further deteriorated.
In September 2018, the FDA reported that the company is recalling all its supposedly sterile products. According to the company’s recall notice dated September 10, 2018,
“Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.”
“Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death. The pharmacy has not received any reports of patient complaints or adverse events related to this recall. To date, Pharm D Solutions, LLC is not aware of any adverse events related to this recall. Nor is there any indication that the compounded sterile drug products being recalled are actually contaminated. No medications or any component thereof have been shown to be non-sterile. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy’s highest priority.”
Pharm D’s recall goes back 12 months. That Is very concerning. It suggests that the company has had continuous sterility problems that go all the way back to its last recall.
If there is any good news, the company reports it is not aware of any adverse events.
Despite near nonstop manufacturing problems, the company’s website continues to claim that its products “meet or exceed regulatory requirements issued by state and federal agencies.”
Potential Whistleblower Reward Opportunities
Federal law offers people with inside information about Medicare or Medicaid fraud to receive huge monetary awards. The awards are based on a percentage of what the government recovers from the wrongdoers.
Pharm D Solutions does maintain a retail pharmacy meaning it makes some sales to the public. Most of its products are sold to hospitals, clinics and physician practices.
We do not know all the products are produced or compounded at Pharm D. We know that its vitamin B-12 and injectable testosterone are probably not reimbursable by Medicare or Medicaid. That could be an important factor if you are seeking a whistleblower reward. Awards are dependent on whether a compounding pharmacy offers products that are reimbursable by Medicare / Tricare / Medicaid. (Most compounding pharmacies do.)
What else does Pharm D Solutions compound? We don’t know. But if you work or once worked there, you know.
Any pharmaceutical company can have a manufacturing problem. Accidents and mistakes happen. The False Claims Act doesn’t punish companies that make innocent mistakes. It addresses fraud. And that occurs when a company continues to market pharmaceuticals knowing or suspecting that they are adulterated / non-sterile / not to proper strength.
To be eligible for a reward, you generally must be the first to report. Obviously, the FDA has already acquired a significant amount of information about Pharm D Solutions. This means you can’t claim a reward based on information from the FDA.
We suspect that there is a tremendous amount of information that the inspectors missed or that the company covered up. This includes knowledge that the company continued to ship products knowing these products had significant sterility and cGMP issues.
The goal of the Pharmaceutical Integrity Coalition is to clean up dirty pharma. We love our industry and believe that patients should always come before profits.
We believe the best way to clean up the industry is by shining a light on greed and corruption. We do that by sharing information we receive from pharma insiders and by empowering whistleblowers to come forward. We provide a safe harbor for QA, DS, DP professionals and other insiders anywhere in the world to report unsafe non-spec drugs being sold into the U.S market and to make cash reward claims under U.S. law.
We can help you decide whether to become a whistleblower, help you find a lawyer and help you find an employment lawyer should you suffer illegal retaliation.
Call for Pharm D Solutions and Other Compounding Pharmacy Whistleblowers
If you have evidence of significant cGMP deviations in the last 6 years for products made by Pharm D Solutions or any other compounding pharmacy or pharmaceutical company, contact us confidentially by emailing us at: [hidden email] or call us at 202.780.9957. We help match would-be whistleblowers with CM&C experts and qualified lawyers to ensure they receive the highest awards possible and protection from retaliation. There is no fee for our services.
The cause of most of the problems in our industry is greed. Profits over people. The effects of this greed are more profound. When pharmaceutical companies focus more on profits than their products, patients can die or suffer needlessly. Adulterated, contaminated, non-sterile, under potent and superpotent products are dangerous.
Whether or not you are eligible for a whistleblower award or even want a reward, we still want to hear from you. Feel free to tell us your story, even if it is anonymous. Shining a light on wrongdoing is one of the most effective ways of cleaning up problems within our industry.
You can find the December 2015 FDA Warning letter here. A copy of the June 2015 FDA form 483 can be found here.
The Pharmaceutical Integrity Coalition (PIC) is an independent Advocacy Group, with no ties to the pharmaceutical industry. Our focus is on health and healing.