These regulations from state and federal governments extend to anyone who manufactures, distributes, dispenses, and sells prescription drugs and devices.
I am a Durable Medical Equipment supplier. Do I need to register for Sales Tax in addition to obtaining a Durable Medical Equipment License?
Many states do require DME suppliers to register for sales tax even though, very often, durable medical equipment is exempt from sales tax. If you are unsure of whether a particular jurisdiction requires you to obtain a Sales Tax ID, please feel free to contact us!
Overview The licensing requirements for suppliers of Durable Medical Equipment (“DME”) or Home Medical Equipment (“HME”) vary across all jurisdictions in the United States. Given that the term DME covers such a wide array of devices, it is not always clear which licenses, if any, a provider may need in order to distribute in any given state. Furthermore, the term “supplier” or “provider” includes DME companies, home health agencies, physicians, and other practitioners. Often, each state varies on which suppliers may or may not be exempt from DME licensing requirements.
Generally, approximately 25 jurisdictions issue Durable Medical Equipment licenses at the state level. However, just because a DME License exists in a state, it doesn’t mean that every DME supplier needs to be licensed. This must be determined on a case-by-case basis, dependent upon what type of equipment is being dispensed, by whom, and to whom. Once it has been determine that a license is, in fact, required, the process typically requires a lengthy application, a fee ranging from $100 to $1,000, extensive supporting documentation, and renewals. Licenses are generally issued by the State Board of Pharmacy of Department of Health. Processing times can be as long as 9 months due to the inspection requirements implemented by the majority of states that license DME providers.
With respect to Durable Medical Equipment providers, states also tend to differs on whether a Pharmacy License or a Sales Tax ID is required. A pharmacy license may be required if the equipment falls under a state’s definition of pharmaceuticals. A Sales Tax ID or a Sales Tax Exemption may be required depending on the types of equipment that fall under a state’s exemption laws. Even for a jurisdiction that does not issue DME Licenses at the state level, the possibility of these other types of licensing requirements should be considered.
Ramifications of non-compliance
A company providing Durable/Home Medical Equipment without proper licensure may be subject to civil and criminal penalties. Companies must be particularly careful to ensure that their employees are properly licensed if they are going to be setting up or installing any of the equipment being provided. In many cases, companies have incurred heavy fines as a result of unlicensed employees. How we help your business: 1) We stay up-to-date with changing requirements and forms so you can focus on the job at hand. 2) We complete license applications efficiently and correctly, allowing your in-house staff to save valuable time struggling to obtain the proper licenses. 3) Once your license has been issued, we ensure that you remain compliant with all licensing laws.
Do pharmacists have to renew their licenses?
Every U.S. state requires a licensed resident pharmacist to renew annually or biennially (every 2 years). Requirements can be complicated when a pharmacist is licensed in other states as a non-resident pharmacist, and prescriptions are mailed.
Typically, resident pharmacist licenses must be renewed every one-to-three years, and most renewal applications may be filed online. The date of renewal is either a fixed annual date or based on the date of issuance of the original license.
A license holder must be diligent about properly renewing his or her license or may face serious penalties for noncompliance.
We are a pediatric therapy clinic where we do speech, occupational, and physical therapy in Wisconsin. We would like to order splints for clients and bill their private insurance. Do we need a DME license?
Not being able to dispense Durable Medical Equipment (DME) from your office could result in a loss of revenue for your practice. Having the ability to dispense supplies to your clients is a convenience to your patients when they do not have to take their prescription elsewhere to receive those additional services. It is important before jumping into offering this service that you make sure that you are compliant with the local laws on DME licenses before selling any products to clients. The failure to be properly license could result in fines to your business or a tarnished business reputation. The State of Wisconsin does not require a Durable Medical Equipment License. However, if your business is selling durable medical equipment in WI, you may still be required to comply with other licensing laws at the state or local level
CT Corporation provides a License Research Service that will:
- Identify the potential licenses that your business might require in every relevant jurisdiction.
- Obtain for you all the necessary application forms and compile a list of required supporting documents.
- Produce a comprehensive report for your records containing forms, filing information, and state fees.
Once you receive your license research packet with all of the applications you need, you can choose to fill them out yourself or have CT Corporation complete the license filings for you.
To get started you will be assigned an account manager who will handle your licenses from start to finish. For more information please contact CT Corporation to consult a licensing specialist.
My business has a Pharmacy License, but we want to begin dispensing medical devices as well. Do we need to get a separate DME license?
In some states, durable medical equipment falls under the umbrella of a pharmacy license. However, in many states, a business like yours would be required to obtain a separate DME license, likely from a different licensing agency. Please contact us if you would like CT Corporation to look into any additional licensing requirements that may affect you.
I own a compounding pharmacy and want to begin dispensing compounded prescriptions by mail-order. Is there a difference between the licensing process for a non-compounding pharmacy versus a compounding pharmacy?
Generally, the licensing process for a compounding pharmacy is different from a standard pharmacy. Compounding pharmacies are often governed by state regulations specific to compounders. The level of record keeping and due diligence often surpasses the standards required for non-compounders. Some states require additional attachments and forms for compounding pharmacies applying for the state pharmacy license. Other states have separate and distinct licenses required only for compounders. The regulatory landscape for compounders is changing rapidly and we expect many states will enact new licensing requirements over the next few years.
In many states compounding pharmacies need the same licenses as a regular retail pharmacy. These licenses are often called a resident pharmacy license for in state pharmacies or a non-resident or mail order pharmacy license for out of state pharmacies. The application process is similar to non-compounding pharmacies in most cases. Applications usually require sample labels, DEA Registration, inspection reports, and corporate documents. Compounding pharmacies must often provide supplemental information and attachments with each application. These can include internal policies and procedures of compounding practices, more stringent inspections, and proof of accreditation.
Some states have a separate license specifically for compounders. The California Board of Pharmacy, for example, requires in state pharmacies either obtain the sterile compounding license or hold current accreditation from through an enumerated list of private accreditation agencies. CA requires that non-resident pharmacies hold the non-resident pharmacy license AND the sterile compounding license AND a current accreditation.
Effective September 2013, the Florida Board of Pharmacy now requires a special sterile compounding permit for resident pharmacies, in addition to the resident community pharmacy license. Sterile compounders have until March, 2014 to obtain the license. This license is not required for non-resident pharmacies at this time.
Other states, including Maryland, have proposed legislation that would require separate licenses for compounders.
CT Corporation will help guide compounding pharmacies through the changing landscape of licensing requirements and regulations. We can help you obtain all of the licenses and registrations you need, minimizing time-consuming and costly delays. If you are already licensed, we can file renewals and manage ongoing compliance. For additional help please contact CT Corporation
How does a wholesale drug distributor get NABP Drug Distributor Accreditation (DDA)?
NABP Drug Distributor Accreditation (DDA) is an accreditation issued by the National Association of Boards of Pharmacy to wholesale distributor facilities. The accreditation ensures that facilities operate legitimately in full compliance of state and federal laws. Twenty one states recognize the accreditation and North Dakota, Wyoming and Indiana require it as an element of the licensure process. The accreditation process involves verification of the distributor’s existing state and federal licenses, criminal and financial background checks, and a detailed review of the company’s policies and procedures. The application also requires a $100,000 surety bond, proof of insurance, photos of facility, list of customers and vendors, a detailed business description and an ownership chart.
The policy and procedure guides required are extensive. Formal company documents must be submitted in the areas of licensing and compliance with laws/regulations, operations, security, records, and many more. These documents must lay out a detailed plan of action for achieving the highest standards of compliance.
The application process takes 7-12 months. The initial fees are approximately $5,000, but they vary based on the number of background checks required. Annual renewals and documentation are required to maintain the accreditation.
Our services will help your company obtain all licenses and registrations and manage ongoing license renewals and compliance with state laws and regulations. For additional please contact CT Corporation
I want to supply home medical equipment throughout the United States. How do I know where I need to be licensed and which licenses I need to get?
Every jurisdiction is different. Some states do not issue Durable Medical Equipment, or Home Medical Equipment, licenses at all, while other states may require a DME license for certain types of suppliers and/or certain types of equipment. CT Corporation can research all 51 jurisdictions for you, and based on the specifics of your business, determine exactly which licenses you need. To get started right away, please please contact us.
Does CT Corporation monitor changes in the Pharmacy industry?
Yes, CT Corporation monitors any regulatory and statutory changes in the pharmacy industry in all 50 states. Wolters Kluwer provides a service known as TRAC (Tracking Regulations And Compliance) which is a quarterly compliance report covering all 50 states as well as the District of Columbia. TRAC summarizes any recent pharmacy licensing law changes and processes being implemented by each state’s board of pharmacy. TRAC provides timely and crucial information on the status of licensing laws across the country. TRAC includes research and analysis of any changes to license processes and procedures, including changes to PDMP programs, controlled substance classifications and new definitions in the pharmacy code. TRAC research also alerts subscribers to any upcoming changes that have not yet been implemented. Additionally, if there is a change in the industry, TRAC will include the necessary forms and information pertaining to that change.
Is it legal to send prescription drugs through the mail?
It is only legal for entities that are registered with the Drug Enforcement Administration to send drugs through the U.S. Postal Service. For example, a drug manufacturer, a registered agent of a drug manufacturer, pharmacy, medical practitioner, mail-order pharmacy, or another authorized dispenser.
Every state in the country requires mail-order pharmacies or web-based pharmacies to be properly licensed before they can legally operate in that state. For every state in which an order is placed, the appropriate license is required but additionally, each state varies on which authority regulates this type of business and what additional licenses are necessary.
State licensing laws and state public health codes all have specific requirements that must be met. CT Corporation streamlines the licensing process for your business so that you can be certain that your mail order pharmacy is fully compliant with all registration requirements.
Do mail order pharmacies need a licensed Pharmacist in Charge in West Virginia?
All Mail Order Pharmacies licensed in West Virginia must have a West Virginia licensed Pharmacist in Charge (PIC) by June 30th, 2014. This date coincides with the WV annual license renewal deadline and the license will not be renewed unless the pharmacy has a PIC licensed in WV.
Per West Virginia Code 30-5-7(a)(13), "Regulation of mail order pharmacies: Provided, That until the board establishes requirements that provide further conditions for pharmacists whom consult with or who provide pharmacist care to patients regarding prescriptions dispensed in this state by a mail order pharmacy, the pharmacist in charge of the out-of-state mail order pharmacy shall be licensed in West Virginia and any other pharmacist providing pharmacist care from the mail order pharmacy shall be licensed in the state where the pharmacy is located."
To obtain a license as a Pharmacist in West Virginia, all applicants must request the license through NABP, prepare an Official application for the West Virginia Board of Pharmacy, and pass the Multistate Pharmacy Jurisprudence Examination (MPJE). The West Virginia licensed PIC does not need to be the home state PIC. All other pharmacists working under the PIC simply need a valid pharmacist license in the state where the pharmacy is located.
CT Corporation will begin the Pharmacist licensing process TODAY. Our skilled Account Managers seamlessly navigate the filing process on your behalf. If you are already licensed, we can manage license renewals and ongoing license compliance. To get started, please contact CT Corporation
Which states require nonresident pharmacies to be licensed?
Currently all states except Massachusetts require out-of-state or mail-order pharmacies that ship drugs to their residents to obtain some form of Nonresident Pharmacy License in their state. Nonresident pharmacy licensing is typically similar to in-state pharmacy licensing, with perhaps a few additional requirements such as the designation of an in-state representative to act as an agent for service of process and other local matters.
Nonresident pharmacy rules differ from state to state; some states require acting pharmacists-in-charge to be licensed through their Board of Pharmacy, while others do not; certain states require nonresident pharmacies to file periodic reports of controlled substances dispensed to their residents. Regulations are always changing - Pennsylvania only recently enacted legislation establishing a nonresident pharmacy license requirement - so it is important to stay abreast of developing legislation in order to remain compliant in the industry.
CT Corporation helps clients stay on top of new requirements and changing regulations. Please contact CT Corporation to consult a licensing specialist.
Which states require Nonresident PIC licensing?
Which states require a nonresident pharmacy’s Pharmacist-in-Charge (“PIC”) to be licensed through that state’s Board of Pharmacy?
Currently, the following states require a nonresident pharmacy PIC to be licensed in their state: Alabama, Arkansas, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Nebraska, Oklahoma, Oregon, Tennessee, Texas, Virginia and West Virginia. Certain states including Iowa and Idaho do not require full state licensure but still require nonresident PICs to register with the Board.
You can get a quote by contacting CT Corporation
Does my pharmacy need a federal license to export drugs?
If your pharmacy exports drugs and biologics to foreign countries, you may be required to obtain an exporters license or certificate issued by the Food and Drug Administration (FDA), the Department of Commerce Bureau of Industry and Security (BIS), and/or the Drug Enforcement Agency (DEA).
Pursuant to FDA regulation, pharmacies are not required to obtain export certificates. However, many foreign governments do require verification of FDA approval from pharmaceutical exporters as an assurance that products being brought and sold in their countries are suitable to be marketed within the U.S. Thus, it is important that pharmaceutical exporters consult with the importing country to determine exactly what type of information is required. If the host country does require such verification, the FDA is legally mandated, upon official request, to issue an export certificate containing vital information about a product’s regulatory or marketing status within the United States.
To apply, pharmacy administrators must consult and complete form FDA 3613b. Exporters must keep in mind that each drug requires a separate application. However, if one drug is being exported to multiple countries, only one application must be used, with separate certificates to be issued for each distinct importing country. Fees include $175 per each certificate, with a reduced fee for each subsequent certificate for the same country in the same application. Certificates will expire 24 months from the date of notification, and thereupon require submission of a new application upon expiration.
According to the Department of Commerce Bureau of Industry and Security (BIS), only those pharmaceutical products classified with an ECCN require an export license. These products include but are not limited to: vaccines, immune-toxins, medical products, diagnostic and food testing kits as specifically listed in the Commerce Control List. To apply, pharmacies should consult form BIS-748P which may also be used to request classification of items/materials to be exported, or to request an advisory opinion as to whether a license is required for a particular item/ material for a given end-user and/ or destination. An export license issued by the BIS is valid for four years from the date issued.
Furthermore, under the DEA, a yearly exporter registration is required for all controlled substances. Pharmacies intending to export controlled substances must consult DEA Form 225 which, upon submission, involves a 4-6 week processing time and requires annual renewal and fees that range in excess of $1500.
Do states require licenses for sterile compounding facilities that are registered with the Food and Drug Administration (FDA) as outsourcing facilities?
A facility that compounds sterile drugs may elect to register with the Food and Drug Administration (FDA) as an outsourcing facility. The registration will help the FDA identify and regulate these facilities. In addition to the FDA registration, many states are beginning to require licenses for outsourcing facilities. For example, states such as Delaware, New York, Mississippi, and Ohio have enacted specific licenses requirements for FDA registered outsourcing facilities. Other states have pending regulations to enact non-resident outsourcing facilities that ship compounded sterile drugs into their states to register as outsourcing facilities. Since these rule changes rely on existing federal law, pharmacies should not wait to comply with any state license requirements that may be required.CT Corporation tracks all licensing regulations in all states for outsourcing facilities. CT Corporation will help guide FDA registered outsourcing facilities through the changing landscape of licensing requirements and regulations. We can help you obtain all of the licenses and registrations you need, minimizing time-consuming and costly delays. To get started, please contact CT Corporation.
My business prepares sterile compounds, do I need to register with the FDA as an outsourcing facility?
A facility that compounds sterile drugs may elect to register with FDA as an outsourcing facility. Each facility at a separate geographic location or address must hold a distinct registration. Outsourcing facilities are subject to GMP requirements and can only compound with drug substances that are on a “clinical need” list established by the U.S. Food and Drug Administration (“FDA”). Outsourcing facilities can compound large quantities of products on FDA’s drug shortage list without prescription and is not required to be a licensed pharmacy. Under the Drug Quality and Security Act (DQSA), an outsourcing facility is not considered registered until all registration fees owed by the facility have been paid. Beginning in fiscal year (FY) 2015, outsourcing facilities that elect to register with FDA must pay an annual establishment fee. Each year, the registration period for outsourcing facilities begins on October 1st and ends on December 31st. The annual establishment fee is paid at the time of registration and is equal to the sum of $15,000, multiplied by the inflation adjustment factor plus the small business adjustment factor. The FDA will publish a notice in the Federal Register announcing the amount of the establishment fee to be collected in a given FY (based on the calculation set forth above) no later than 60 calendar days before the start of that FY. Beginning in FY 2015, an outsourcing facility will be assessed a reinspection fee each time it is subject to a reinspection. Reinspection is defined as: “one or more inspections conducted under section 704 subsequent to an inspection conducted under such provision which identified noncompliance materially related to an applicable requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction.” The reinspection fee is designed to reimburse FDA when it must visit a particular outsourcing facility more than once because of noncompliance identified during a previous inspection. The reinspection fee will be equal to $15,000 multiplied by the inflation adjustment factor. The inflation-adjusted reinspection fee for each FY will be published in the Federal Register not later than 60 calendar days before the start of each FY.
Outsourcing facilities registered before October 1, 2014 do not have to pay a fee for FY 2014. To maintain their status as outsourcing facilities in FY 2015, however, those entities will have to register during the FY 2015 registration period (October 1 – December 31, 2014). Failure to pay the fee by December 31, 2014, will result in an entity losing its status as an outsourcing facility.
In addition to the FDA registration, many states are beginning to require licenses for outsourcing facilities. CT Corporation tracks all licensing regulations in all states for outsourcing facilities. Let us help you determine which licenses your company needs, obtain all licenses, and manage ongoing license renewals. For additional help please contact CT Corporation to consult a licensing specialist.
What license does a pharmacist need?
A Doctor of Pharmacy degree (PharmD) from a school or college of pharmacy that is accredited by the Accreditation Council for Pharmacy Education is required to become a licensed pharmacist. You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. Each state may have different individual requirements for obtaining a pharmacist license.
A pharmacist must obtain a pharmacist license in any state in which he/she is dispensing pharmaceuticals. Typically, once licensed in his/her home state, he/she may apply for a pharmacist license in another state through reciprocity, making him/her eligible to waive certain requirements with respect to the licensing process. If the pharmacist will be acting as a pharmacist in charge for a pharmacy, requirements for pharmacist licensure may change depending on the states in which the pharmacy is located and intends on operating.
CT Corporation will research pharmacist licensing requirements, file and manage all pharmacist licenses and pharmacist renewals on your behalf.
For more information and assistance, please contact CT Corporation to consult a licensing specialist.
How long does it take to get a wholesale drug distributor license?
The licensing process for Wholesale Drug Distributors varies significantly from state to state. States, along with the federal government, have an interest in maintaining the availability of safe and effective drugs for public. Depending on the state, licensing approval timelines for Wholesale Drug Distributors range from weeks to months. Let CT Corporation streamline the process for you by providing comprehensive research to ensure that all of your licensing requirements are met.
All fifty states require Wholesale Drug Distributors to obtain a license before they may engage in any wholesale drug distribution activities within the domestic state. The procedures that each state follows vary, and the more information required by the state, the longer the process may take. Most states require background checks, submission of facility floor plans, proof of insurance, disclosure of all operating officers, and surety bonds for liability purposes. In states like Alaska where the licensing requirements are fairly straightforward, a business may obtain its Wholesale Drug Distributor License within two to three weeks. However, in states such as California, the process may be far more tedious, requiring not only the basics, but also requiring the Wholesale Drug Distributor to obtain approval by both the FDA and DEA. A handful of states also require VAWD certification by the National Association of Boards of Pharmacies, or a similar entity. In states requiring additional certifications, the processing time may range from one to three months. Furthermore, should a Wholesale Drug Distributor choose to expand into another state, the licensure process must be recommenced in the new state, resulting in additional processing time.
Failure to comply with licensure requirements for Wholesale Drug Distributors may result in civil and/or criminal penalties at both the state and federal level. Wolters Kluwer assists with license compliance by making sure Wholesale Drug Distributors stay up to date on licensure requirements, filings, and renewals so you can focus on growing your business. We will complete all applications on your behalf both efficiently and accurately, and ensure that your licenses remain up to date. Please contact CT Corporation to consult a licensing specialist.
What licenses do Wholesale Drug Third-party Logistics Providers (3PLs) need?
Third-party logistics providers offer “supply-chain” services to producing entities, maintaining one or more cogs in the flow of goods and products from the initial point of production to the final destination – the consumer.
Whether you are a group that specializes in obtaining raw materials needed for drug manufacturing, a storage facility that houses a distributor’s product while it is being prepared for shipping, a trucking company that transports pharmaceuticals from one place to another, or a comprehensive 3PL that handles all of these services together, there are important legal requirements that your business must satisfy.
United States law requires a wholesale drug 3PL to be licensed in the state in which it does business. In certain states, there is a license specific to third-party logistics providers. Florida, for example, requires 3PLs to obtain a Third Party Logistics Provider License from the Division of Drugs, Devices and Cosmetics. Other states may not have a specific 3PL license and may require the 3PL to become licensed as a wholesale drug distributor or other type of entity. The department that administers the appropriate license varies from state to state as well. If the 3PL transports drugs between states, it must be licensed in all of the states in which it does so. If the state in which the 3PL does business has not established a 3PL license requirement, the 3PL must file with the U.S. Secretary.
Applying for the appropriate license in each required state can be comprehensive and time-consuming. Applicants will typically be asked to provide samples of contracts, lists of customers and states in which the 3PL operates, and proof of general liability insurance. Application fees can range from several hundred to several thousand dollars. If you maintain a brick-and-mortar facility, you will more than likely be subject to state inspection of that facility. The entire approval process can take between four weeks and three months depending on the licensing division in the state in which you are applying.
In addition to obtaining a license in each state in which your 3PL operates, there may be other requirements that your company must satisfy in order to remain compliant. For instance, the FDA requires that a wholesale drug 3PL file an annual report of every state in which it operates, its applicable license numbers and expiration dates, and records of any disciplinary actions it incurred that year. It goes without saying that failure to comply with any facet of federal 3PL regulations can result in heavy fines, cease-and-desist orders, and potential disintegration of your business.
How can CT Corporation help third-party logistics providers?
- CT Corporation will research the licensing requirements for every state and jurisdiction in which you operate.
- Your Dedicated Account Manager will then prepare and submit your 3PL license applications and consolidate all license fees into one simple invoice, saving you time, money, and frustration.
- Once your licenses have been issued, we ensure that you renew on time and remain compliant will all 3PL licensing laws.
If you’re a 3PL, you recognize the benefits of outsourcing complicated aspects of an industry to experienced professionals. Let CT Corporation handle the licensing of your third-party logistics provider. Please contact CT Corporation to consult a licensing specialist.