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  • Writer's pictureLindsay Wall, PharmD, RPh

Specialty Pharmacies & Drugs 101


Are you interested in opening a small pharmacy business that sells specialty drugs? If so, there are a few things to keep in mind as you move through the process. HVRS Solutions is here to break down important information about these unique and vital establishments.


If you want to know what a specialty pharmacy is, what patients they serve what types of drugs they provide, and how to get started, you can learn more by reading below!


What is a specialty pharmacy?

According to the American Pharmacists Association, specialty pharmacies are businesses that sell and distribute specialty medications, which often cost more than other drugs. To get accredited as a specialty pharmacy, you must meet and adhere to stringent requirements.


Due to the nature of the medications specialty pharmacies provide, they are also required to maintain a comprehensive patient management program, including patient education, monitoring, and medication management.


What do specialty pharmacies do?

There are several key ways that specialty pharmacies differ from local or community pharmacies. Most notably, specialty pharmacies…


  1. Are usually open seven days per week with extended hours.

  2. Carry medications not typically found in regular community pharmacies.

  3. Adhere to FDA requirements for prescribing and dispensing specialty medications.

  4. Provide personalized patient care that begins as soon as their first prescription gets filled.

  5. Have a team of specialized pharmacists and staff members available to provide 1-on-1 patient support, monitoring, and guidance.

Since these types of pharmacies specialize in specialty medications, they are required by law to take all necessary measures to ensure proper dispensing and delivery. They can insert a cold pack for medications that need to remain at a certain temperature, ship medications overnight as needed, and provide self-administration supplies like syringes, sharps disposal kits, cleansing alcohol swabs, and more.


Who gets specialty drugs from pharmacies?

People with a wide variety of chronic conditions use medications to manage symptoms, improve overall quality of life, and follow their personal treatment plan. A few of the many conditions and diseases specialty pharmacies might provide medications to treat include:


● Anemia

● Cancer

● Cystic Fibrosis

● HIV/AIDS

● Rheumatoid Arthritis


Specialty drugs are FDA-approved medications used to treat complex medical conditions, such as complicated diseases and disorders. Often, they require specific storage, preparation, and handling procedures to ensure they work as intended. Because of this, they are normally must more expensive than other prescription and over-the-counter medications. For more information about specialty drugs, check out this article.


What are the requirements for becoming a specialty pharmacist?

As specified by the National Association of Specialty Pharmacy (NASP), you must have a pharmacy degree from an accredited U.S. institution, an active pharmacy license, and good licensure standing. Along with that, you need to have completed a 30-hour specialty pharmacy continuing education course within the last two years and 3,000 hours of specialty pharmacy practice within the last four years.


The final part of the initial Certified Specialty Pharmacy process is a background, code of conduct, and application accuracy check, followed by an examination. You can learn more about the certification process by visiting the NASP website.


What other accreditations and certifications do specialty pharmacies need?

If you are serious about starting a specialty pharmacy or want to enhance your credibility, then you need to know about the Utilization Review Accreditation Commission (URAC). It is the leading provider of pharmacy accreditations and certifications. Specialty pharmacies must update their policies and procedures to align with URAC requirements annually in order to maintain their accreditation status.


The HVRS Solutions team can help you apply for URAC accreditation and maintain your certification by updating your policies and procedures to align with all requirements. Contact us for more information about our specialty pharmacy and URAC accreditation services.


Learn more about specialty pharmacies & medications

Wherever you are in your specialty pharmacy journey, whether you’re a pharmacist continuing their education or a current business owner, HVRS Solutions can help. Our knowledgeable team is here to streamline your application, continuing accreditation, and annual certification processes, so you can focus on patient care management and day-to-day operations.

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