PharmElite Compounding will be the go-to outsourcing facility in the rapidly expanding pharmaceutical compounding market.

Every day, drugs are combined or altered in some way to create new forms of drugs that better suit the end user’s needs. With an ever-increasing number of facilities choosing to outsource their drug compounding, combined with new federal policies coming down the pipeline eventually requiring this, PharmElite is getting ahead of the curve by building a brand new state-of-the-art facility that meets all current and future policies and regulations.

Compounding drugs requires the expertise, precision, and experience of pharmacists. While there are many pharmaceutical compounding facilities currently in operation, only a very small handful have a staff with the right qualifications. The PharmElite team is comprised of talented pharmacists and technicians who are already experts in large-batch manufacturing. Simply put, we have an unparalleled level of understanding of the regulations and requirements that go along with this industry. In an industry with an extremely high barrier to entry for competition, PharmElite is on the right side of that barrier.

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PharmElite Compounding will be an elite pharmaceutical compounding facility that will quickly take a major share of the rapidly expanding sterile compounded pharmaceutical market.

There is a growing demand for outsourced compounding due to its ability to provide sterile and stable products, with ensured potency, extended expiration dates and efficient ready-to-dose preparation sizes. Despite this demand, current compounding facilities are failing FDA regulations left and right, creating an opportunity for new players to enter the space. PharmElite is seizing that opportunity.

Every single one of these roughly 75 million annual surgeries requires at least one injection, and often several more than that. Having medications available in ready-to-administer dosage forms enables hospitals and surgery centers to:

• Save time by eliminating bedside preparation and labeling of the product(s)
• Eliminate medication waste at the facility
• Eliminate calculation errors and potential over/underdosing
• Virtually eradicate contamination and infection risk from poor aseptic technique
• Remove errors caused by mislabeling (or not labeling) multiple syringe preparations

Some degree of compounding is always handled in-house, but the vast majority of facilities:

• Simply can’t keep up with the demand
• Don’t have the same level of expertise in compounding
• Don’t want to assume the legal risk involved
• And understand that even if they try to handle almost everything in-house, a guaranteed 20% of compounding has to be sent away for testing anyways.

The time is right for us because as the demand for compounding rises to record highs, the number of current compounding facilities running into trouble with the FDA is also rising. New FDA standards are causing current compounding companies to restructure, leaving an opening in the market for us to build a state of the art facility from the ground up that meets all the new requirements.

In addition to complete FDA compliance, PharmElite Compounding will be the first choice for healthcare facilities for the following reasons.

PharmElite has the best compounding team, not only for our education and training, but because we have all worked together on a daily basis for several years. Compounding on this scale requires great teamwork, and we have that in spades.

Our team is efficient, cooperative, and synergistic. Perhaps most importantly, we all care deeply about large-batch compounding and have committed our careers to it. Because of this, we’re able to optimize production under the shared vision of making PharmElite the most reliable and efficient outsourcing compounding facility in the nation. We know each other’s strengths and have come together to form a cohesive unit, working in unison to create the best compounds available. The team section below highlights our specific skills and training.

Combined, these factors put PharmElite ahead of the game within an industry that is becoming more reliant on our services every day. In the coming years, there will be a lot of companies trying to jump on the large-batch pharmaceutical compounding bandwagon. PharmElite will not only beat them to the punch, but our team’s training, skills, and cohesiveness will ensure we always do it better than anyone else.

Here are a couple of realistic examples of potential PharmElite Compounding customers.

Farma Hospital is a small rural inpatient facility with only about 150 beds. Their 2 staff pharmacists and 3 technicians service the whole hospital, including narcotics delivery, Pyxis refills, IV preparation/batching and order entry/verification. Their staff is sufficient for their current needs, but they have been noticing an increased amount of wasted compounds due to the shortened beyond use dating they must use in an isolator hood. They also know these time frames are soon to be even shorter with USP <800> mandating the use of an isolator hood within an ISO 7 environment. In order to minimize the product waste, they decide to contact PharmElite for their premade vancomycin and oxytocin bags, as well as OB epidurals, which have extended room temperature stability.

A new ambulatory surgery center is opening in South Carolina, an adjacent state to PharmElite Compounding. The number of medications they use is not diverse, so they want to explore the option of using a compounding facility to provide the standard 20 drugs that they need for their surgeries on a daily basis. The choice to use PharmElite becomes simple: They won’t have to worry about the safety and risk involved with having their surgery physicians and anesthetists prepare every injection at bedside, they don’t have to worry about wasting drugs, they don’t even have to hire a pharmacist or license themselves as a pharmacy, both extremely costly endeavors. With PharmElite, they are assured stability, sterility and extended beyond use dating, as well as saving the surgeons and anesthetists tons of time.

We’ve been making significant strides towards an open, fully operational, and state-of-the-art PharmElite Compounding facility.

What’s Next?

• Hire web developer to build payment processor with industry compliant software
• Order the clean room, refrigerators, compounding tables, etc.
• Lease a building
• Register with the DEA and FDA
• Start formulating recipes
• Inspection
• Compound products
• Source customers
• Down the road, we also plan on expanding into veterinary compounds

We’re well on our way, but you can help make PharmElite a reality even quicker! Please request access to the business plan tab of this profile for full details.

There’s a very limited number of facilities that have a staff qualified to do this level of compounding, and PharmElite is one of them. A number of existing facilities are discovering that they don’t have the qualifications needed, and as a result, are losing customers; in some cases, closing their doors altogether. This won’t be an issue for PharmElite.

In addition to the extensive qualifications our team already has, we are in the process of securing certifications that will qualify us to handle narcotics and other controlled substances. This will further entrench PharmElite as the only compounding facility fully equipped to handle the job.
 

Dr. Albers provides the leadership to the team in both a figurehead and executive capacity. She provides direction and guidance to ensure efficiency among the team as well as managing all production deadlines and daily workflows, label design and approval, executive tasks, etc. In addition to her doctorate in pharmacy, she also holds a bachelor’s degree in business.

Mrs. Cooper provides balance from an operational standpoint, and a technician’s point of view. Optimization of operations and procedures will be focused on, with an emphasis on utility and functionality. Specializing in human resources, her unique perspective will contrast with the purely scientific outlook of the other members of the team.

Dr. Brown will provide the necessary oversight in recipe formulation and standardization needed to ensure products are consistent and reliable in terms of potency and stability. Completion of media fill tests as required as well as sterility testing for products will help to ensure customers are receiving the best injections possible, consistently and reliably.

Dr. Harper has the tenacity and attention to detail that is needed in order to ensure cGMP requirements and FDA regulations are being adhered to. Holding staff to the most rigorous of expectations while staying current with new rulings will ensure continued 503B registration and approval.

Dr. Anderson’s narcotics expertise ensures a seamless transition once PharmElite needs to begin ordering controlled substances for production. She also ensures all DEA requirements for documentation and tracking are met to the fullest degree.

Mrs. Britt will be responsible for all aspects of purchasing and acquisitions, as well as ordering and timeline management. Ensuring product is on hand for future preparations (incoming product orders), replenishing stock and supplies, managing drug shortage interchanges and product distribution will be her focus.

To sum it all up: There is a major market opportunity in this industry, and PharmElite is uniquely qualified to capture it.