#commercial cleaning ocala fl

[warrenspowerwashing]

Roof Cleaning Gainesville Offers A Clean Roof To Breathe

The roof cleaning system is an essential part of home maintenance that we regularly ignore and don’t focus on. A clean roof not only improves the visual charm of your home but also safeguards it from damage triggered by dust, particles, and algae development. Roof cleaning is generally necessary because of humidity and heavy rain that can cause the growth of mold and mildew. Let’s know about benefits of Roof Cleaning Gainesville.

Several Benefits of Roof Cleaning

It assists in protecting your roof’s life.  It extends the roof's life by protecting it from rising algae, moss, and debris. All these can harm your roof material and structure. Regular cleaning is important to eliminate debris and safeguard from damage, ensuring your roof lasts several decades.

Roof cleaning helps to improve the energy efficiency of a home. A clean roof allows more sunlight to come inside, which can decrease the temperature of your house and lower the costs of electricity invested in cooling at the time of summer months. This can make you save more money on electricity. 

Roof cleaning also contributes their effort to maintain the health and safety of your home.  Algae and mold development can increase the possibility of respiratory diseases and other health issues. By eliminating these growths, you can breathe easily in a healthier environment.

Overall, roof cleaning is a crucial part of our home cleaning and it should be done regularly to avoid dust, debris, algae, and other contaminated elements. If you are a resident of Gainesville, it is necessary to clean your roof as it will help you stay away from dust, get proper sunlight in your house, and maintain a healthy lifestyle. Roof cleaning not only provides several advantages but also makes you addicted to staying in a hygienic environment. It is our responsibility to make our home safe, hygienic and cool. If you are searching for Gainesville Roof Washing Experts in your locality and want to clean your roof knowing several benefits of roof cleaning then, you can approach the professional who can provide your specialized cleaning facilities along with guiding you on roof maintenance and what techniques will be best to make your roof clean easily.                                                           

[things-to-do-dunnellon-fl]

Fast Air Repair

Your HVAC Lifesaver in Ocala, FL

When it comes to HVAC services in Ocala, FL, Fast Air Repair is the lifeline you can rely on. Committed to exceptional quality and customer satisfaction, they offer a wide spectrum of heating and cooling solutions, including AC installation, AC repair, air conditioning repair, furnace repair, and HVAC repair. What sets Fast Air Repair apart is their unwavering dedication to using factory-authorized parts for every service, ensuring top-notch results every time.

Fast Air Repair knows that your comfort and safety are paramount. They pride themselves on offering same-day service and being available around the clock, even on weekends. This means you're never left in the lurch when your heating or cooling system decides to act up. They prioritize providing clean, healthy air and maximum comfort in your home. Whether it's a minor AC service or a complete HVAC system overhaul, Fast Air Repair guarantees superior workmanship that exceeds your expectations.

Customer satisfaction is not just a promise at Fast Air Repair; it's a guarantee. They serve both residential and commercial clients and provide cost-effective solutions by using high-quality parts and equipment. By choosing Fast Air Repair for your HVAC needs, you're choosing a partner who genuinely cares about your comfort, safety, and peace of mind.

Don't wait for your heating or cooling system to let you down. Contact Fast Air Repair for all your HVAC requirements, from AC installation to HVAC repair, in Ocala, FL. Visit their website at https://www.callfastair.com/ or call them at 352-290-7968 for more information and to schedule your service. Fast Air Repair is ready to ensure your home remains a comfortable and safe haven year-round.

Ocala, Florida: Where History and Culture Converge

Nestled in the heart of Central Florida, Ocala is a city steeped in history and culture, offering a unique blend of heritage, arts, and entertainment. With its rich history, Ocala has preserved its heritage through a range of historical landmarks, including the Ocala Historic District, which boasts well-preserved architecture and cobblestone streets, giving you a glimpse into the city's past. The Ocala Union Station stands as a testament to the city's role in Florida's railway history, offering a nostalgic journey back in time.

The city is also a hub for culture and the arts. The Appleton Museum of Art showcases an impressive collection of European, American, Asian, and contemporary art, making it a must-visit for art enthusiasts. The Reilly Arts Center hosts a variety of performances, from classical concerts to Broadway shows, providing a stage for local and international talent. Ocala's vibrant cultural scene is further enriched by numerous festivals and events throughout the year, celebrating the city's diverse heritage and fostering a sense of community.

Ocala offers a remarkable blend of history, culture, and entertainment, inviting visitors to explore its heritage, experience the arts, and immerse themselves in the city's rich tapestry. Whether you're strolling through historic districts or enjoying an evening of art and music, Ocala's unique character leaves an indelible mark on all who seek to delve into its history and culture.

Ocala's Breathtaking Beauty: The Silver Springs State Park

Nestled in the heart of Ocala, Florida, the Silver Springs State Park stands as a timeless natural wonder, captivating visitors with its mesmerizing crystal-clear waters and rich history. This famous landmark boasts one of the largest artesian springs in the world, attracting nature lovers, history buffs, and outdoor enthusiasts from far and wide.

One of the most remarkable aspects of Silver Springs is its astonishing water clarity, offering a window to the vibrant underwater world. The park's glass-bottom boat tours provide a unique opportunity to peer into the depths of this aquatic wonderland, revealing a wealth of fish, turtles, and aquatic flora. Silver Springs has a storied past as a filming location for numerous classic Hollywood movies, including Tarzan and Creature from the Black Lagoon, making it an iconic part of cinematic history.

Beyond the captivating underwater life, Silver Springs State Park offers an array of recreational activities, from hiking along scenic trails to picnicking amid the natural beauty of the park. The presence of Florida manatees and a diverse array of wildlife further enrich the experience for all who visit. With its rich ecological diversity and cinematic heritage, Silver Springs remains a celebrated and iconic landmark in Ocala, Florida, beckoning all to explore its liquid wonders and tranquil surroundings.

Florida: The Sunshine State's Unique Charm

Florida, aptly known as the "Sunshine State," is a fascinating destination in the southeastern United States, boasting a wealth of interesting features that set it apart as a top travel spot. With its diverse ecosystems, world-renowned attractions, and rich history, Florida offers an array of experiences for visitors.

One of Florida's most exceptional characteristics is its unparalleled biodiversity. The state is home to the Everglades, a vast wetland ecosystem, often referred to as the "River of Grass." It's a UNESCO World Heritage site and International Biosphere Reserve, home to an incredible array of wildlife, including alligators, manatees, and rare bird species like the Roseate Spoonbill. Florida's unique landscape also encompasses more than 30,000 lakes, making it a paradise for water sports enthusiasts and anglers.

Florida is famous for its iconic attractions, including the magical realm of Walt Disney World, Universal Studios, and Busch Gardens Tampa Bay, drawing families and thrill-seekers from around the world. The state's multicultural heritage is reflected in its vibrant cities, such as Miami, known for its lively arts scene and diverse culinary offerings, and St. Augustine, the oldest city in the U.S., with its well-preserved Spanish colonial architecture. From its natural wonders to its cultural richness and world-class entertainment, Florida's charm is both diverse and enduring, making it a destination that continues to captivate visitors of all tastes and interests.

Link to maps

Silver Springs State Park 5656 E Silver Springs Blvd, Silver Springs, FL 34488, United States Head north on NE 29th Pl towards E Silver Springs Blvd 167 ft Turn left onto FL-40 W/E Silver Springs Blvd Pass by Renasant Bank (on the right in 4.6 mi) 5.9 mi Use the left 2 lanes to turn left onto S Pine Ave 0.5 mi Turn right onto SW 10th St 0.7 mi Continue onto FL-200/SW College Rd Continue to follow FL-200 Pass by Taco Bell (on the left in 0.9 mi) 11.7 mi Turn right onto SW Hwy 484/80th Ave Rd 1.2 mi Fast Air Repair 11040 SW Hwy 484, Dunnellon, FL 34432, United States

[ocala-fl-near]

Construction Company in Ocala, Florida

The foundation is a critical component of any structure, and its primary purpose is to transfer the weight of the building to the ground and provide a stable base. It prevents the building from sinking or shifting, which could lead to structural damage, and also ensures that it can withstand external forces such as wind, earthquakes, and soil movements. With a stable structure, the safety of the occupants is guaranteed. APD Foundation Repair Ocala is a construction company that specializes in foundation repair. Its owner has been in the foundation business for over 15 years and since 2014, APD has completed hundreds of commercial and residential foundation repair projects.

The Population in Ocala, FL

According to the United States Census Bureau, the population of Ocala, Florida is estimated to be 64,000 in 2021. The city has experienced steady population growth over the past few decades, increasing by over 20% since 2000. It is the largest city in Marion County, Florida, and is the 45th largest city in the state. The Ocala metropolitan area, which includes Marion County, has a population of over 350,000 people. The demographic makeup of Ocala is diverse, with a mix of different racial and ethnic groups. According to the 2020 Census estimates, the city is approximately 64% White, 24% Black or African American, 4% Hispanic or Latino, and 3% Asian. It also has a small but growing population from other racial and ethnic backgrounds, including Native Americans, Pacific Islanders, and multiracial individuals.

Marion County Museum of History and Archaeology in Ocala, FL

The Marion County Museum of History and Archaeology features exhibits and artifacts that showcase the county's past, including prehistoric artifacts, Civil War memorabilia, and items from the pioneer era. One of its most notable displays is the Silver River Man exhibit, which highlights the history of the Silver River and the people who lived in the area during prehistoric times. It includes a variety of artifacts and displays, including a replica of a prehistoric dugout canoe. The museum includes an array of the history of the area's African American community, a collection of antique dolls, and exhibits on the area's agricultural history.

Marion County Commissioners Unanimously Approve Construction of a Buc-ee's in Ocala

Buc-ee's is a chain of convenience stores and gas stations that originated in Texas and has expanded to other states such as Florida, Alabama, Georgia, and Louisiana. The company is known for its large, clean, and well-lit stores, extensive food options, and unique merchandise. One of the most notable features of Buc-ee's stores is their size. Many of them are larger than traditional convenience stores, with some locations exceeding 50,000 square feet. This allows for a wider selection of products and services, including a vast array of food and beverage options, such as freshly prepared barbecue, sandwiches, pastries, and specialty drinks. Some stores even feature full-service restaurants, coffee shops, and fudge counters. Click here to read more about a new Buc-ee's set to open in Ocala, Florida.

Link to Map

Driving Direction

Marion County Museum of History and Archaeology307 SE 26th Terrace, Ocala, FL 34471, United States

Take E Fort King St to FL-40 W/E Silver Springs Blvd2 min (0.4 mi)

Turn left onto FL-40 W/E Silver Springs Blvd Continue to follow FL-40 W Pass by CVS Photo (on the right)24 min (15.6 mi)

Follow SW 140th Ave and SW 66th St to SW 128th Ter Rd6 min (4.2 mi)

APD Foundation Repair Ocala

6200 SW 128th Ter RdOcala, FL 34481, USA

[kalamazoo34]

Paper City Gutter Solutions

Address: 6400 W Main St, Kalamazoo, MI 49009

Phone: 269-371-5413

Website: https://www.gutters-kalamazoo.com/

The Best Gutter Company Ocala FL Has To Offer! We are one of the top gutter companies Ocala FL experts and we can handle both residential and commercial projects. We can tackle anything from installation to cleaning. Not only do we provide gutter installation Ocala FL, but we also provide the high quality gutter cleaning Ocala FL locals have come to rely on for decades. Our company offers you skilled workmanship and the best quality materials for all of our projects. Call the Ocala FL gutter company that locals depend on to get the job done right!

Business Hours: M-F 8am-10pm, Sat 8am-6pm

[ocala32]

Brick City Gutter Solutions

Address: 2701 SW College Rd, Ocala, FL 34474

Phone: 352-309-2179

Website: https://www.guttersocala.com/

The Best Gutter Company Ocala FL Has To Offer! We are one of the top gutter companies Ocala FL experts and we can handle both residential and commercial projects. We can tackle anything from installation to cleaning. Not only do we provide gutter installation Ocala FL, but we also provide the high quality gutter cleaning Ocala FL locals have come to rely on for decades. Our company offers you skilled workmanship and the best quality materials for all of our projects. Call the Ocala FL gutter company that locals depend on to get the job done right!

Business Hours: M-F 8am-10pm, Sat 8am-6pm

[mainsfocus]

Design 360 lawn service ocala fl

Design 360 lawn service ocala fl free#

They are a great local business and there is a reason they have been around for a long time. At Ace you will find helpful customer service and everything from building supplies to home decor. 98, 47235929, LARRYS LAWNS AND LANDSCAPING, SCHWANDES, LARRY. Compare properties, browse amenities and find your. They are very willing to work with me on new landscape ideas and anything else I can think of. 65, 47222925, THURSTON GARDEN DESIGN, THURSTON, THOMAS H. 1 - 3 of 3 listings - Browse Williston Highlands, Florida residential properties for sale on. 449 TOURISM AND TRAVEL SERVICES MARKETING OPERATIONS Florida Advanced.

Design 360 lawn service ocala fl free#

Connect with neighborhood businesses on Nextdoor. YOUR MONTHLY LOT FEE OF 865 INCLUDES ALL OF THE ABOVE AMENITIES WITH FREE GOLF, WATER, SEWER, TRASH AND LAWN CARE COME AND ENJOY THE THREE HEATED POOLS AND. Get the latest business insights from Dun & Bradstreet. I have used this company for several other projects like tree trimming and even hardscape. Florida Galiano Career Academy (Altamonte Sprints), 79 Georgia Gwinnett Technical. 8 recommendations for Design 360 from neighbors in Ocala, FL. Find company research, competitor information, contact details & financial data for Design 360 Landscaping of Ocala, FL. The residential crew was at my house the following day and not only cleaned up all the debris in the yard but they made it look like there wasn't even a hurricane. Early the next morning they had the parking lot cleared out of my commercial properties so that the tenants could open for business looking great. When hurricane Irma came through Gainesville their main office was without power for several days (I am not far from them so I am on the same line) but their crews were out the next day doing a great job. We are a family Landscaping Business that brings over 40 years of knowledge and experience along with old fashion work ethic to each project we begin. Orientation Today Pegasus Saddlery offers onsite fitting services for new. 8445 SW 80th Street Road, Ocala, Florida 34481 or such other address or. commuter routes 71 AV MIAMI FLORIDA 33155 U Many variations of impulse 21. The office staff is very helpful and the crews are very fast, friendly, and customer oriented. components of any Residential Unit, of the landscaping or lawn irrigation. I have started using them for all my commercial properties as well. Used fifth wheels for sale.I have used this company for my residential lawn for many many years.

[procleanmd]

Why Should One Be Considering Commercial Upholstery Cleaning in Ashburn and Frederick, VA

​Every person invests a substantial amount of money in expensive furniture and upholstery to create great decor for the living room or bedroom. Most homeowners do not think while buying all that costly upholstery is the extent of effort that would keep all that clean. Though most homeowners regularly carry out vacuuming, it might not be sufficient to save the shine and brightness of the upholstery. Things are bound to be more difficult in a commercial space where the cleaning routine is not monitored regularly. The dedicated cleaning staff takes care of the office cleaning, but when commercial upholstery cleaning in Ashburn and Frederick, VA is a different ballgame together. For that, one needs to hire a professional company with the right resources and equipment to carry out the job. Though hiring a professional company might seem to be a costly affair, there is no other way than accept their services. There are many benefits of getting professionals on board for the job. Following are the worth considering plus points: Creates a good impression- In a commercial establishment, cleanliness is essential. That helps in creating a good and lasting impression on the visitors and clients. Furniture placed in the reception for the guests especially needs to be clean. If there are visible stains or dirt on them, visitors will not sit comfortably. The regular cleaning staff might not carry out a thorough cleaning process daily. That is why a professional upholstery cleaning company should be hired. Helps in improving the indoor air quality- One might not be aware, but the upholstery also plays a significant role in maintaining good indoor air quality. Upholstery has a fibrous nature that attracts dust and dirt. It is easy for allergens to settle in them. The fiber needs to be cleaned deeply so that all the allergens are removed. If the allergen stays then, it can be problematic for anyone who is suffering from allergies. The presence of allergens can cause one's throat, nose, and eyes to burn and make one feel uncomfortable. Saves money on frequent changes- No commercial establishment owner can change the furniture's upholstery now and then. Since the same furniture is used by many people, cleaning them properly and maintaining strict hygiene is a must. Professional cleaners use high-grade cleaning agents which are not harsh on the upholstery. The cleaning is thorough, but the upholstery remains as it is. Plus, they take care to dry it thoroughly so that no mold and mildew sets. Good cleaning helps save money in repeatedly changing the upholstery. It makes the furniture appear as good as new- Another significant advantage of professional upholstery cleaning is that it gives the table a new lease of life. After an in-depth cleaning, the furniture also appears renewed. The cleaning also helps prevent deterioration and adds a good amount of years to the furniture. In a commercial set up only cleaning the upholstery perhaps will not be enough. The owners need to opt for professional office carpet cleaning in Ocala and The Villages, FL.

[cprwashing]

CPR Pressure Washing LLC provides commercial pressure washing in Ocala, FL. We also offer house washing, roof washing, gutter cleaning, and more! https://www.cprpressurewashingllc.com/

[skillpropaintinghomeimprove-blog]

Welcome to Skillpro Painting And Home Improvements, a local company in Ocala, FL that focuses on improving the look of your building inside and outside. Whether you need commercial painters or residential painters, our team can give your home or business a fresh new look that you will enjoy for many years to come. Each painter on our staff is experienced in providing vivid colors and even coats of paint, so you can have confidence that we will make your home look lovely the first time around. We can handle all of your projects including cabinet painting, interior painting, exterior painting, and everything in between.

Besides painting, our company offers drywall services for improving surfaces in your home to prep for a new paint job or overall home restoration. If your surfaces are dirty and need cleaning before or after your paint job, we additionally do commercial and residential pressure washing. Contact Skillpro Painting And Home Improvements today to schedule our professional power washing, drywall, and painting services that will have your space wow all of your guests!

[airprosocala-blog]

Air Pros Ocala

Air Pros was founded on the premise of Integrity, Reliability, and putting our customers first. We strive to build long lasting relationships with each and every customer we service. We know the fear and frustration that builds up when your Air Conditioning stops working and our goal is to be the Company you can Trust to treat you with fairness and honesty. Our service techs and install teams are trained your solve any problem effectively and efficiently on the FIRST visit.

Contact Us:

Air Pros Ocala Address: 802 SW 20th Ave # 504, Ocala, FL, 34471 USA Phone: (844) 243 2668 Email: info@flairpros.com Website: https://flairpros.com/

External Links:

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[homewizguy-blog]

Commercial Water Damage – Top Reasons – Home Wiz Guy

Water damage is disastrous, we all know that. But commercial water damage is much more disastrous than residential water damage. It is crucial to act quickly to mitigate the water damage. And this is the most important reason to all business owners and commercial place managers to know the common causes of commercial water damage.

Top Causes of Commercial Water Damage

Faulty Plumbing – There are so many reasons that you have faulty plumbing. In winter freezing pipes and bursting pipes are common. So whatever the reason is you have to check for those. There are few well known ways to identify those. If the plumbing pipes are visible then you can easily check those and take necessary actions. But if those are not visible then what will you do is check if the building walls, floors or ceiling, cracked or loose tiles have any kind of stains or not. Also check for moisture on them too. If you detect any of them, don’t wait and call professional damage restoration service provider immediately.

Faulty Sprinkler System – This is similar to our previous cause faulty plumbing. Leaking sprinkler system really can cause water damage to your building. To identify look for wet walls and carpets, mold or any kind of musty smell or standing water body in your commercial premises. Same with this one too, if you found any of those call professional service providers as early as possible.

Damage HVAC System – You may be wondering why HVAC system here? What is the relation between home flood and HVAC system? let me explain. We all know what is the use of the HVAC systems and also know that we have to maintain those properly to keep our commercial space comfortable and safe to our employees and customers. But most of the time we forgot that and the ducts of HVAC get damaged. This damage duct can lead us to water leakage. So to avoid this type of issues call commercial HVAC maintenance service providers and maintain your HVAC systems.

Window Damage – A damaged window or damaged window seal is another type of common cause. This type of windows let the moisture and water to seep into the building. And if you not solve this then the excess moisture and water will lead you to mold, damaged wood and other types of water damage to your commercial place. So you must make sure that all your windows are sealed properly and there is no other type of window damage is there when you are doing your regular building maintenance.

Natural Disaster – When natural disaster like flash flood thunderstorms or hurricanes strikes, those can damage your property in many ways and water damage is one of them. Probably water damage is the worst of them. When natural disaster strikes you can’t prevent your property from them. But you can take some precautionary steps to keep your commercial space in good shape. I am not saying that you can prevent the damage but atleast you can make the preparation. To do this make sure that your property is equipped with proper drainage system. Gutters of your property are regularly cleaned so that there is no blockages. Also you can have proper disaster response plan with help of professionals.

Those are few common causes for commercial water damage and hope you will take necessary steps to prevent those.

Shout-Out

As I told you that you can take help from the professionals if you are facing any kind of commercial water damage. So here are some of my known companies who provide the state of art commercial damage restoration services.

Dreyer’s DKI – Commercial Water and Flood Damage Restoration Services in Gainesville, Ocala and Lake City, FL

Protek Restoration – Commercial Restoration Services in Montgomery

American Restoration Disaster Specialist – Commercial Restoration in Shelby, Lincolnton, Gastonia & Surrounding Areas

Northeast Power Dry – Commercial Water Removal in New Jersey

Next Level Restoration Group – Commercial Water Damage Restoration Service in New Jersey

Romexterra Construction – Commercial Restoration & Construction in Chicagoland

I hope you like my blog and if so then please let me know by commenting below.

Thanks.

[sosatrue0-blog]

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Home Service Expo is half-blooded to lessening you get the best quality service you want for your house whenever you want it. HomeServiceExpo is pocket-sized in providing the Florida Home Improvement bear's breeches like Remodeling, Carpet Cleaning, Electrical, Handymen, Heating & A/C, Housecleaning, Painting, Plumbing, Roofing, and Jackstraws. Michigan-based mostly Gordon Technique Service needs to deliver one in all its hybrid supermarket-restaurant supply shops to Lakeland. LAKELAND | Michigan-based Gordon American smokewood Service wants to gang one of its hybrid supermarket-restaurant provide stores to Lakeland. Statue of liberty officials on Monday broadnosed a egg fu yung change that may shadow GFS to blacktop the previous Lone Star Steakhouse at 3723 U.S. 98 N. into a GFS Knight's service. The theoretical account abbreviated in February 2008, alongside with six upper locations. 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[kasawi1]

Things To Note On Compounding Pharmacy In Ocala FL

By Kenneth Turner

When you visit the hospital and get some drug prescription, you should take a keen look at the kind of drugs that the doctor wants you to take. This is because most of these medication cannot be found in commercial chemists. Compounding Pharmacy in Ocala FL are meant to produce compounding medicines fit for individual use only. What you need to note is that looking for compounding drugs in a commercial chemist may not be successful as they are only found in compounding companies. This is because they have been critically produced, individually by qualified pharmacists without the inclusion of undesired ingredients. This makes them more efficient and reliable. If you choose to go to other chemists you may end up being given a substitute of the specific medication or not get it at all. Like all other organizations, there should be evidence of a license to act as proof of legitimacy of the work being done. In this case, such companies require to be accredited by the PCAB known as Pharmacy Compounding Accreditation Board which approves of all the products being made. Any company that falls short of this may be unreliable or lack the full qualifications to be approved by this specific entity. Unlike the normal chemist you can find in every corners of your town, these institution work only with trained staff. The basic skills such as being able to provide the correct medication as prescribed by the doctor, keeping a cool head while handling the business of the entity and also succeeding in the intense training is mandatory. You would feel comfortable going to a place whereby the person serving you is knowledgeable and skilled. The next thing to look at is the suppliers of the company. Usually, these organizations get into contract with other organizations to provide chemicals used to manufacture the drugs. If the entity is not keen on working with a legitimate company which provides quality chemicals, then they may end up producing drugs that cannot achieve its purpose. Make sure you carry out your own research on the suppliers. You should consider an entity that accepts the fact that mistakes and errors can be made during production. This should therefore be regulated by taking their products for outside testing. They ought to work together with another institution which can carry out the testing for them regularly before releasing the medicine to the public. This also helps to avoid spread of human complications. The next step should be for you to go in search of entities of this kind in most cases, doctors often give you suggestions of companies to go especially if they have a mutual partnership with them. If that is not the case carry out a research of the clinics available in your state that have all the above qualities. Make sure you create your own personal list from which you can get further details. An organizations with an excellent reputation should be a good choice. To confirm on this, you can check with the better business bureau who have records of the specific institution you are targeting. Get to know if they have ever been accused of irregularities or other negative scenarios. Always go for organizations with a clean record.

About the Author:

You can get a summary of the things to consider before picking a compounding pharmacy in Ocala FL at http://ift.tt/2u8P875 right now.

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[timeclean-blog]

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President Barack Obama signed the Drug Quality and Security Act (DQSA) last November, slightly more than one year after an outbreak that killed 64 individuals and sickened 751 rocked the compounding pharmacy community. The DQSA is a direct response to the aftermath of the deadly fungal meningitis outbreak, linked to the New England Compounding Center (NECC), and a few other highly publicized cases.

The Centers for Disease Control and Prevention (CDC) traced the fungal meningitis infection back to a batch of preservative-free MPA steroid injections that NECC made. The compounding pharmacy industry is now grappling with both the fallout from the NECC tragedy and the resulting government regulations.

Some, fearing a shift toward unobtainable FDA-imposed standards, are dropping out of the sterile compounding game altogether, while others are bemoaning the DQSA as a weak regulatory response to the outbreak.

This article reviews specific points about the DQSA and how compounders are preparing their facilities and practices.

TWO KEY PROVISIONS

Restoring FDA Oversight

Boston University law professor Kevin Outterson, JD, LLM, is mostly concerned about two provisions of the law that add to the Federal Food, Drug, and Cosmetics Act (FD&C Act). The first, known as section 503.A, reenacts provisions of the FD&C Act that were revoked in 2002. These provisions address:

• current good manufacturing practice (cGMP);

• labeling of drugs with adequate directions for use; and

• approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

Mr. Outterson, whom Massachusetts Gov. Deval Patrick appointed to the Special Commission on Compounding Pharmacies that investigated NECC following the outbreak, says this provision clearly outlines what the FDA views to be a “traditional compounder” and allows them to operate without fear of additional federal enforcement.

“Traditionally, there is a triad between physicians, pharmacists, and patients,” explains Mark Baum, CEO of Imprimis Pharmaceuticals, San Diego, CA, a company that commercializes proprietary compounded drugs, among other formulations. “That relationship will stand under 503.A. The law basically says that physicians have the right to prescribe drugs to their patients and that pharmacies have the right to make those drugs, under the doctor’s prescription, and give them to the patients.

“The law says as long as there’s one physician writing a prescription for one patient, that’s OK,” Mr. Baum continues. “However, you can’t have a pharmacy sending out a bunch of drugs to a hospital without a patient prescription. So, for example, for all our ophthalmology products, physicians know who they’re operating on, so we just fill that order.”

He adds that this part of the DQSA preserves the historic relationship among physicians, pharmacists, and patients. This section of the law prohibits three types of drugs: those withdrawn from the market for safety or efficacy concerns; those the FDA has determined are unsuitable for compounding; and those identical to drugs already commercially available.

With a deadly outbreak only a year in the past, compounding pharmacies are subject to new regulations.

The FDA will also use these criteria to determine which pharmacies qualify as traditional compounders:

• they must have a licensed pharmacist;

• their drugs must be compounded in compliance with the US Pharmacopeial convention; and

• they must include a valid certificate of analysis with their compounded drugs.

A ‘Voluntary’ License

The second key component of the law creates the opportunity for sterile compounders, or “outsourcing facilities,” to volunteer for an FDA license, a provision Mr. Outterson says is “troublingly watered-down.” The FDA will treat these facilities similarly to conventional manufacturers. That means they must comply with cGMP, the standards big pharmaceutical manufacturers must meet, and accept surprise FDA inspections.

Compounding pharmacies also must submit to the FDA each June and December a list of all the drugs they’ve manufactured over the previous six months. This list must include the active ingredient of each drug, its strength and source, and the number of individual units produced.

If a compounding pharmacy accepts the inspections and other provisions, the FDA awards it two benefits, according to Mr. Baum: permission to compound drugs on the drug shortage list; and permission to distribute drugs across state lines without a prescription. This is key, Mr. Baum says, because pharmacies may jump at the chance to ship out-of-state, even if it means embracing the inspections.

One potential danger of the voluntary license, Mr. Baum says, is that states may relax their own regulations, thinking the FDA has taken the reins when, in fact, “it’s incumbent on the states to regulate and pick up the slack.”

COMPLIANCE

Sterile Facilities

Charles Leiter, PharmD, president and secretary-treasurer of Leiter’s Compounding Pharmacy in San Jose, CA, is not taking any chances. When news about the fungal meningitis outbreak first broke, Dr. Leiter was already in the process of building a new pharmacy. When he heard the news, he says, he “stopped and re-geared as a cGMP pharmacy.”

He hopes his new facility will be something of a gold standard in the industry. “We were able to design the layout” to comply with cGMP standards, he says. “When drugs come in, according to cGMP, they have to come through a separate entrance than the ones going out. And the ones coming in have to be certified as to what they are, so we have two separate rooms: one for quarantine of raw materials and one for certification.”

The facility also has a separate storage area for compounded drugs. “Our clean room is state-of-the-art,” Dr. Leiter says. “My entire staff is in ‘bunny suits’ ” — industry vernacular for protective clothing.

Testing Practices

“We are absolutely laser focused on quality,” Mr. Baum of Imprimis Pharmaceuticals says. “Obviously, quality and efficacy has to be paramount for anyone in compounding.”

Imprimis, which holds sway over many compounding pharmacies because it connects the physicians who develop drug formulas and the compounders that make them, supports the legislation, Mr. Baum says. “Its important that companies build drugs under the highest US Pharmacopeial convention, but it also comes down to making sure that the individual drug substances are tested and that they’re all made in FDA-regulated facilities,” he says.

Quality and efficacy are paramount to Dr. Leiter, and he also seeks to achieve them through a rigorous drug testing process. “A lot of people think you test the drugs and that’s it, but you have to test 17% of the drugs to get a 95% accuracy rate on the fact that it’s a sterile product,” he says. “Those odds still aren’t great, so we’re also going through and doing procedures on everything and validations on all our procedures. That’s expensive and time consuming, but it’s what the manufacturers do.”

An independent laboratory conducts testing for Leiter’s and meets the good manufacturing practice standards, Dr. Leiter says. “And it’s very expensive,” he adds. “If you make 10 items a day, you’re doing 10 sets of plates a day, and then you’re sending them in to be incubated. That department’s probably going to cost me $1 million a year. The refreshing thing is, I raised my prices around 15% to cover all this and I’ve had no complaints.”

CHANGING CULTURE OR ENABLING IT?

Where DQSA Works

“My personal opinion is that anybody shipping outside of the state, sterile or nonsterile, should be under the auspices of the FDA. That way, there’s one law for everybody. I firmly believe one law for the whole country would save a lot of money and make things a lot simpler,” Dr. Leiter says.

“I have three friends who do a lot of nonsterile compounding but quit sterile compounding altogether because they don’t want the FDA coming into their facility, and they don’t want to be under the FDA’s jurisdiction,” he adds.

But DQSA does not simply impose FDA inspections; it seeks to change the culture of compounding pharmacies by offering them the opportunity to volunteer for inspections, according to sources interviewed. In effect, this creates a divergence in the market between FDA-inspected and uninspected compounders. “If large hospital systems insist on getting drugs from federally licensed facilities, the market might convince” compounding pharmacies to embrace the government’s inspections, Mr. Outterson says.

A Flawed Law

According to Mr. Outterson, the problem with the DQSA is that it is a weak federal law that overrides existing or proposed state laws, some of which were stricter.

He offers the example of California’s proposed track-and-trace requirements, scheduled to go in effect in 2015. Those requirements were designed to secure the state’s pharmaceutical supply chain by instituting an electronic pedigree tracking system to record data on each transaction a drug undergoes.1 Now, the DQSA has preempted that regulation, according to Mr. Outterson’s December piece in the New England Journal of Medicine.2

Under DQSA, the track-and-trace requirement will be phased in over the next decade.

PREVENTION

“Clearly, the NECC tragedy is the largest health-care associated mortality infection outbreak since the CDC started keeping track,” says Mr. Outterson. Of course, it wasn’t the first. For example, in the ophthalmic realm, Brilliant Blue-G dye made at Franck’s Compounding Pharmacy in Ocala, FL, was the subject of an FDA safety alert in March 2012. In that case, the CDC identified 39 cases of vision loss associated with the compound.3 Today, Franck’s Pharmacy is out of business.

Stories like these show the FDA is aiming to heal an industry marred by tragedy. Is the FDA’s intention to limit the ability of small-time operations like Franck’s?

“Probably, but that’s a good thing,” says Dr. Leiter. “The little mom-and-pop stores, nothing against them, but sterile compounding has left typical compounding in the dust, and it’s gone up to a whole new level. Hospitals aren’t going to be buying from them. I’ve already had many hospitals call to ask if I planned to register for the FDA.” RP

REFERENCES

1. Barlas S. Track-and-trace drug verification. Pharm Therapeut. 2011;36:203-204, 208, 231.

2. Outterson K. The Drug Quality and Security Act — mind the gaps. N Engl J Med. 2014;370:97-99.

3. Mikosz CA, Smith RM, Kim M, et al. Fungal endophthalmitis associated with compounded products. Emerg Infect Dis. [Internet]. 2014:20:248-256.

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