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Pennsylvania Department of Health
Drug, Device and Cosmetic Program
FAQs (Frequently Asked Questions)
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  *GENERAL INFORMATION

*Does an out of state/nonresident pharmacy need to register with the Department of Health?

*Does a Pennsylvania licensed Pharmacy need to register with the Department of Health?

*What are Some Examples of Medical Devices Requiring Registration?

*What if my Facility (manfuacturer, distributor, 503B) is Located Out-of-State/nonresident?

*What if my Business is a Charitable Organization?

*What if my Business is Leasing Space at an Already-Registered Facility?

*What are Some Common Examples of Non-Prescription or OTC Products Requiring Registration?

*What Defines a Manufacturer and When do they Need a Distributor's License?

*Do Commercial Warehouses or Third Party Logistics (3PL) Need to Register?

*What Other Drug or Device Registrations Will I Need?

*What is the definition of a Cosmetic and what are registration requirements for manufacturing or distirbuting?

*What are the main laws/regulations governing pharmaceutical distribution?

*What is the Noncontrolled Substance Registration and Reporting Act?

*What Businesses Can Register Under Fee-Exempt Status?

*What, if any, are the personnel requirements for a distributor/wholesaler or manufacturer of drugs?

*Pharmaceutical Compounding vs. Pharmaceutical Manufacturing

*Can a pharmacy distribute drugs or act as a distributor?

*Where can I find information on the pseudoephedrine sales restrictions?

*What do I do if my business name or address changes?

*What do I do if our business undergoes a change of ownership?

*How do I renew my registration/license?

*Does a licensed practitioner or healthcare facility need to register separately with the Department of Health Drug Device Cosmetic Program?

*What is required to register an in state pharmaceutical manufacturer or repackager facility?

*Do consultant firms assisting registrants or licensees need to file with the Department of Health?

*Is Oxygen a prescription drug?

*Are dental laboratories required to be registered?

*What defines a change of ownership?

*Are Researchers required to be registered or licensed by the Department of Health to receive prescription pharmaceuticals and related products?

*Is there a fee and what is the process to complete a verification form for another state?

*Will I receive a renewal notice when it is time to renew ny registration or license and when canI expect this form?

*Does an out of state medical device supplier need to register or be licensed?

*My Medical Device company is participiating in competitive bidding for CMS/Medicare. Do we need to register in Pennsylvania?

*Is there guidance on electronic prescribing in Pennsylvania?

*How do I find out if there have been changes to a Pennsylvania statute or regulation?

*Where can I get more information about electronic prescrbing or dispensing of controlled substances?

*What are the application registration and/or license fees for pharmaceutical, controlled substance, API, medical devices, or cosmetic facilities ?

*What are the Registration Requirements for Oxygen and/or Medical Gases?

*Do I need to register if my company is only handling API (Active Pharmaceutical Ingredient)?

*What is a certificate or letter of record?

*How do I obtain a certificate or letter of record?

*How do I get a Verfication Form completed that another State is requesting?

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    GENERAL INFORMATION
    Any business (each location) in the Commonwealth who is physically manufacturing, compounding under 503B, distributing, or retailing drugs (prescription, controlled substances or over-the-counter), medical devices, and/or medicated cosmetics in accordance with the Controlled Substance, Drug, Device and Cosmetic Act (Act 233 of 1972)(DD&C Act) must register with the Pennsylvania Department of Health. A Certificate of Registration will be issued to the applicant upon registration. Note practitioners and healthcare facilities engaging in the above activities AND wherease the above activities are noted as part of their scope of practice do not need to register (i.e. physician dispensing medical devices to his patients after medical evaluation) In addition to the registration requirement, any distributor of prescription drugs or controlled substances, needs to comply with the licensure requirements under the Wholesale Prescription Drug Distributors Licensure Act (Act 145 of1992)(WPDDL Act). A Certificate of Licensure will be issued to the applicant upon meeting all requirments for licensure. Any Pennsylvania located distributor of prescription drugs or controlled substances (actually handling product), needs both registration and licensure. Pennslyvnai located Brokers or other entities not actually handling product are not required to reigistration or obtain liicensure
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    Does an out of state/nonresident pharmacy need to register with the Department of Health?
    Any pharmacy practicing with the scope of pharmacy practice(i.e. filling patient specific prescription orders) is regulated by the Board of Pharmacy not the Department of Health and thus any questions must be directed to the Board of Pharmacy at email ST-PHARMACY@pa.gov or check their website at www.dos.pa.gov/pharm for current pharmacy requirements including for out of state/noresident pharmacies. Pharmacies that are acting beyond their scope of practice such as pharmacy businesses that are manufuacturing, wholesale distributing, or engaging in 503B activities should review FAQ regarding out of state manufacturers, wholesale distributors, or outsourcing facilities (503B).
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    Does a Pennsylvania licensed Pharmacy need to register with the Department of Health?
    Pharmacies may need to register/obtain licensure with the Department only if they acting beyond their scope of pharmacy practice or license. Examples may include: 1. The pharmacy is distributing quanity of drugs that is more than 5% of their inventory (ie the distribution of minimal quantities less than 5% of product by a licensed retail pharmacy to a licensed practitioner for office use, where a licensed practitioner is defined as one is licensed or authorized by State law to prescribe drugs, is permitted (21 CFR 203.3.)(see FAQ on pharmacies and distribution for more information). 2. The pharmacy is manufacturing or compounding drugs, not for a specific patient or prescription order. (see FDA.gov for more information on manufacturing vs. compounding before contacting the Department.) 3. The business is operating as a retailer of over-the-counter drug products with no pharmacist on duty or pharmacist supervision. 4. Other pharmaceutical or medical device activities that are beyond the scope of practice of pharmacy. Please review the state Pharmacy Practice Act.
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    What are Some Examples of Medical Devices Requiring Registration?
    Any manufacturer, distributor and/or retailer of medical devices within the Commonwealth must register unless acting with scope of practice license (i.e. Physician providing medical devices to his/her patients). A medical device is an instrument or apparatus and parts and accessories used to diagnose, cure, mitigate, treat or prevent disease in man or animals. Some common examples of medical devices and facilities: Dental laboratories, dental equipment sellers, optical laboratories, eye glasses/contacts retailers, prosthetics sellers, orthotics sellers (specialized footwear/repairs/braces), dialysis equipment, hearing aid manufacturers and repairs facilities, etc. Note: Some devices contain prescription drugs or controlled substances. If a device contains prescription drugs then the business should register as a manufacturer, distributor or retailer of prescription drugs or controlled substances IF classified as such by the Federal Food and Drug Administration (FDA)
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    What if my Facility (manfuacturer, distributor, 503B) is Located Out-of-State/nonresident?
    Registration may apply : Any out-of-state US located business that manufactures or distributes drugs or medical devices into the Commonwealth or is engaged in 503B activities, is required to register ONLY if the out-of-state facility employs or engages sales representatives within the Commonwealth (ie boots on the ground) or is handling List I chemicals (common examples include ephedrine or pseudoephedrine). A current list of sales employees (name and addresses) may be submitted annually in lieu of fee with the registration application. All out of state applicants must submit or fax copies of their home state and/or federal license expressing good standing. Out of state virtual manufacturers that need to register must submit home state or federal license/registration if available and federal labeler code. Even if virtual manufactuer is exempt from home state and federal licensing a FDA labeler code and DUNS registration must be submitted along with a letter identifying the state exemption. Any out-of-state business (with no sales representatives) that manufactures, compounds, or distributes drugs or medical devices into the Commonwealth may voluntarily apply for a certificate of Registration (with fee) and receive standard issued certificates provided they submit copies of their home state and/or federal license expressing good standing. Licensure does not apply to nonresident manufacturers or distirbutors and is issued for in state facilities. Out-of-state/nonresident pharmacies or Internet pharmacies need to contact the Board of Pharmacy at ST-Pharmacy@pa.gov or 717-787-8503 for the latest governances related to practice of pharmacy and requirements by the Board of Pharmacy. Out of state DME providers wishing to bill medicare for DME supplies please visit www.palmettogba.com/nsc under the DMEPOS state licensure directory. Under Pennsylvania see special notes. Note: Any business must be registered or licensed in the state in which they are located in order to distribute prescription drugs into the Commonwealth. Please include a copy of your resident state registration/license when submitting an application.
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    What if my Business is a Charitable Organization?
    Regardless of profit status, any entity (other than practitioners-see FAQ) physically manufacturing, distributing, or retailing drugs or devices located within the Commonwealth must register. However, non-profit organizations can have the fee waived by sending a copy of their 501© docuemntation to us at the time of new application and renewal of registration at: PA Department of Health Drug Registration Section 132 Kline Plaza, Suite A Harrisburg, PA 17104 or by fax (717) 772-0232. Applications for Registration can then be completed under the fee-exempt status. An official certificate will not be mailed until the 501© form is received.
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    What if my Business is Leasing Space at an Already-Registered Facility?
    A separately owned company that is leasing space in a registered facility must register, even if they are using the same name as the register facility. Contract third party logistics do not need to register each client they are serviciing,only if a separate area of a warehouse is leased. For example, ABC optical leases space from Supermart Drug Store and calls themselves "Supermart Optical," they are a separate company and therefore must register regardless of the physical location and its registration.
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    What are Some Common Examples of Non-Prescription or OTC Products Requiring Registration?
    Some common examples of non-prescription products requiring registration are “Tylenol,” aspirin, “Maalox,” cough drops, anti-perspirant deodorants, diet aids, First Aid kits, fluoride toothpaste, eye drops, gauze and medicated Band-Aids, veterinary drugs, contraceptive devices, incontinence pads, and some vitamins and herbal products. Only herbal products or vitamins that contain a drug product such as ephedrine m or which are promoted to treat, cure mitigate, or prevent disease in man or animals, mandate registration.
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    What Defines a Manufacturer and When do they Need a Distributor's License?
    A manufacturer is defined as a facility that physically produces, transfills, repackages, relabels, prepares, propagates, compounds, converts, or processes a controlled substance, drug, device, or cosmetic. A Pennsylvania regoistered manufacturer who sells or ships prescription and/or controlled substances to another facility or business, unless owned by the same corporation (i.e. intracompany) or othewise exempt under federal law, must also apply under the PennsylvaniaWholesales Prescription Drug Licensure Act.
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    Do Commercial Warehouses or Third Party Logistics (3PL) Need to Register?
    Yes, even though commercial warehouses within the Commonwealth do not own the products, they are still physically storing, transferring, and acting as a distributor by definition under the Pennsylvania Drug, Device, and Cosmetic Act and need to register. Nonresident Commercial Warehouses or Third Party Logistics (3PL) only need register if they are shipping products containing a List I chemical (ie pseudoephedrine, GHB, etc) Commercial Warehouses or Third Party Logistics (3PL) Nshould also review the federal Drug Quality and Supply Act for possible licensure requirements and other compliance requirements. Virtual businesses or headquarters located in Pennsylvania that do not handle acutal product, are not required to register.
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    What Other Drug or Device Registrations Will I Need?
    For facilities handling controlled substances or List I chemicals, registration with the Federal Drug Enforcement Agency (DEA) is required. For facilities manufacturing or outsource compounding drugs, devices, or medical gases, registration with the Federal Food and Drug Administration (FDA) is required (www.fda.gov). For facilities handling bedding and upholstery (ie hospital beds), registration with the Pennsylvania Department of Labor and Industry is required (www.li.pa.gov). For facilities handling veterinary/animal products, registration with the Pennsylvania Department of Agriculture may be required (www.pda.pa.gov). For facilities handling the destruction of drugs or medical devices, registration with the Pennsylvania Department of Environmental Protection may be required (www.dep.pa.gov). For facilities handling orthotics or prosthetics, individual practitioners may need to obtain licensure from the Board of Medicine (www.dos.pa.gov/med) For General business or entreprenurial information in the Commonwealth, please check the Pennsylvania Department of Community and Economic Development (www.dced.pa.gov) For facilities handling bulk powders of drug products, registration may be required under the NonControlled Substance Reporting and Registration Act. (Please contact the Drug Registration Section for this application and more information.) Please note: all business must be properly registered to do business in Pennsylvania with the Pennsylvania Department of State, Bureau of Corporations (www.dos.pa.gov). Registration with the Pennsylvania Department of Revenue may also be applicable.
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    What is the definition of a Cosmetic and what are registration requirements for manufacturing or distirbuting?
    Generally cosmetic is any substance that is intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body or animal body for cleansing, beautifying, promoting attractiveness or altering the appearance. The term shall not include soap (see below) (FDA link may provie further guiadance on soap vs. cosmetic vs. drug: www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm. Manufacturers, distributors, or wholesalers of cosmetics within the Commonwealth must register. Manufacturing includeds producing, preparing, propagting, compounding, processing, repackaging, or relabeling. Cosmetic facilities must maintain sanitary conditions, proper recordkeeping, and adhere to federal labelling requirements (see www.fda.gov). Cosmetic manufacturers are encouraged to participate in the federal VCRP program- voluntary cosmetic registration program overseen by the FDA. Please note: SOME COSMETICS MAY BE CONSIDERED DRUGS: Any cosmetic promoted to treat, mitigate, prevent, or diagnosis a disease in man or animal AND/OR any cosmetic containing an active pharmaceutical ingredient AND/OR any cosmetic meeting any definition of drug under federal or state law is deemed a drug or cosmeceutical. Some product types such as lip balms are also classified as drugs. Manufacturers or Distributors of cosmetics deemed cosmeceuticals or drugs must adhere to all requirements related to DRUG manufacturing including but not limited to approval of specific prodcut, registration with FDA, and adherence to GMP (good manufacturing practices). Visit the FDA website under cosmetics and under drugs for further information. Also FDA's article “Are all personal care products regulated as cosmetics?” on their website may be helpful with regards to specific products as such as lip balms. Also soap versus cosmetics- FDA website may provide further guiadance on soap vs. cosmetic vs. drug: http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm
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    What are the main laws/regulations governing pharmaceutical distribution?
    While not all inlcusive, the key Federal and Pennsylvania laws/regulations: PA. Controlled Substance, Drug, Device, Cosmetic Act PA. Controlled Substance, Drug, Device, Cosmetic Regulations (PA Code of Regulations) PA. Wholesale Prescription Drug Distributors License Act Federal law ( general links can be through FDA website) Federal Prescription Drug Marketing Act Federal Drug Quality and Supply Act Federal Food, Drug, Device, and Cosmetic Act Federal Modernization Act All interested applicants should carefully review applicable laws and regulations prior to submission of application to the Pennsylvania Department of Health
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    What is the Noncontrolled Substance Registration and Reporting Act?
    This statute, also known as the Precusor Law, requires businesses manufacturing, distributing, or retailing certain List I chemicals and/or very specific drugs to obtain a separate registration under this law and submit quarterly reports to the Pennsylvania Department of Health and the Attorney General’s office. This statute includes in-state as well as out-of-state facilities shipping in to Pennsylvania. No fee is applied, only registration and reporting is required. A list of relevant List I chemicals and/or specific drugs is available under the statute portion of this web page.
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    What Businesses Can Register Under Fee-Exempt Status?
    Any nonprofit manufacturer, distributor, or retailer with federal tax-exempt 501(c) status can request their fee be waived. (See charitable organization details on this page). Certain out-of state manufacturers, distributors, and retailers can request their fee be waived (see out-of-state registrations details on this page). No additional fees are required for businesses that also are required to register for handling chemicals/drugs listed under the Non-Controlled Substances Registration and Reporting Act (NSRRA). (See the NSRRA under the statute portion of the web page and/or the NSRRA details on this page.)
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    What, if any, are the personnel requirements for a distributor/wholesaler or manufacturer of drugs?
    A Pennsylvania distributor/wholesaler of prescription and/or controlled substance must employ a Pennsylvania licensed pharmacist, ACS certifed chemist, or other person with at least 3 years documented verifiable experience as qualified by scientific, technical, professional or educational training specfically in the distribution of pharmaceuticals to physically oversee the day to day operation. Applicant may need to provide documentation of current Pennsylvania pharmacist license, ACS chemist licensure/ certification, or employment records and job description from a U.S. licensed wholesale distributor in addition to criminal background check. A Pennsylvania manufacturer, repackager, relabeler, or 503B of any drug product must employ a Pennsylvania licensed pharmacist, ACS certified chemist, or other person with at least 5 years documented and verfiable experience in pharmaceutical manufacturing repackaging, relabeling, or 503B to physically oversee the day to day operation. A manufacturing repackager, relabeler, or 503B site must also be registered with the Federal FDA.
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    Pharmaceutical Compounding vs. Pharmaceutical Manufacturing
    Interested parties should review federal law including but not limited to the Federal Food, Drug, Device, and Cosmetic Act,, the Federal Prescription Drug Marketing Act, and the Federal Drug Quality and Security Act. In general compounding is producing a drug (not comercially available or banned) pursuant to a prescription order for specific patient, whereas, manufacturing is the producing a drug that is approved by the FDA through drug application process. The FDA does permit an exemption for federally registered outsourcing facilities or 503B facilities to produce or compound nonpatient specific, not commercially available sterile drugs for office use without approval of the drug application process under certain guidelines. For more guidance and information, please vist the FDA website (www.fda.gov) or review the aforementioned laws. The Pennslyvania Department of Health does not provide an exemption to federal drug manufacturing or compounding laws.
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    Can a pharmacy distribute drugs or act as a distributor?
    A pharmacy may distribute minimal quantities of no more than 5 % of their annual total prescription drug sales of FDA approved manufacturered product to licensed practitioner for office use, where a licensed practitioner is defined as one is licensed or authorized by State law to prescribe drugs,(see FDA website or Federal Register -21 CFR section 203 for more informaiton or guidance) Note, obtaining a distribution license/registration does not authorize a licensed pharmacy to act as a wholesale distributor or exceed 5% distribution. Both federal and state laws clearly outlined a limited exemption for a licensed pharmacy to distribute because the federal and state laws never intended for a pharmacy to act as a distributor. (This was reaffirmed in public hearings on the issue previously held by the federal government and the issuance of separate laws, separate licenses, and separate requirements) Thus a wholesale Distributor license/registration are separate from any pharmacy license and all inventory, product, storage, records, etc. is separate from the pharmacy. Furthermore, under the law, holders of distribution license must actively engage in wholesale distribution and use the license and registration for intended purpose, meaning actively and physically receiving, storing, and distributing product under the license. Distributor handling human prescription drugs in Pennsylvania must apply and have both a registration and license. All licensed and registered pharmaceutical distribution facilities must adhere to several federal and state laws, including some recent new federal laws and regulations. This includes but not limited to full pedigree rules, personnel requirements, physical standards, written polices/procedures, and authorized distributors of record requirements. Wholesale distributors must obtain drugs from a licensed distributor or manufacturer. All interested parties are strongly recommended to review the laws themselves or hire appropriate legal counsel, to avoid misunderstanding of the laws and regulations and ensure appropriate compliance.
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    Where can I find information on the pseudoephedrine sales restrictions?
    The Federal USA Patriot Improvement and Reauthorization Act of 2005.This Federal Act included Title VII, also known as the Combat Methamphetamine Epidemic Act (CMA) of 2005. Title VII places restrictions on the storage and sale of pseudoephedrine and ephedrine based products. Pennsylvania participates in the federal NPLEX sales reporting system. Questions regarding Pennsylvania & the NPLEX system can be submitted to panplex@appriss.com or 1-855-675-3972
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    What do I do if my business name or address changes?
    Notify our office when your address or business name changes within 15 business days – the information can be faxed to us (fax 717 772 0232) – include your certificate number plus your old and new address/business name. Please include a statement noting that it is only a name or address change and not any change in ownership. A new certificate will be mailed to you reflecting the change. A department name or employee title may be designated on the mailing address but not an individual name. Out of state facilities must submit a copy of their home state license reflecting the change.NOTE: a Change of ownership requires a new application to be submitted.
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    What do I do if our business undergoes a change of ownership?
    A new application must be completed and submitted. Please include the old certificate of registration number. Business name can be the same or different. Mail (to address on application) or fax (717-772-0232) application within 15 business days of the change of ownership.A new certificate of registration and number will issued and mailed. A department name or employee title may be designated on the mailing address but not an individual name. Out of state facilities must submit a copy of their home state license reflecting the change. DO NOT SUBMITT APPLICATION PRIOR TO CHANGE OF OWNERSHIP!
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    How do I renew my registration/license?
    Renewal notices are mailed approximately ***6 WEEKS*** prior to the certificate expiration date as a courtesy to the address on file. If using a credit card for payment, upon receipt of the renewal notice you can renew your registration/license online utilizing your pin number and certificate number or fax the completed form to our office at 717-772-0232. The form may also be mailed to our office - Drug, Device, & Cosmetic program 132 Kline Plaza, Suite A, Harrisburg, PA 17104 if using check/money order. If you do not receive a renewal notice it is still your responsibility to renew in a timely manner before the registration/license expires. You may renew your registration or license without the notice by submitting a request to our office for renewal with the appropriate fee,noting the registratin/license numbers, name and address along with a statement attesting that the information, business type, and ownership have not changed. The renewal form should note any recent business changes to the registration/license such as address, name, mailing address etc. Changes to ownership require the submission of a new application. You may contact our office at 717 783 1379 or 717 787 4779 with any questions.
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    Does a licensed practitioner or healthcare facility need to register separately with the Department of Health Drug Device Cosmetic Program?
    A licensed practitioner or healthcare facility (licensed issued by Department of State or Health) and his/her business does not need to register with the drug device, or cosmetic program separately unless the practitioners’ activities are directed towards other businesses or patients other than his/her own or the practitioner or healthcare facility is acting beyond their scope of practice or license. Please note, Pennsylvania does not currently issue separate controlled substance licenses for licensed practitioners or licensed healthcare facilities. Examples whereas a practitioner or facility may need to register separately include: 1. Optometrist filling prescription issued by another doctor for glasses/contact lenses 2. Optician not under the direct supervision of an optometrist 3. Dentists providing dental apparatus to people other than his/her own patients. 4. Physician operated a separate DME business 5. Business with orthotisists and prothestist acting not direclty under a licensed physician or healthcare faiclity
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    What is required to register an in state pharmaceutical manufacturer or repackager facility?
    Interested parties must complete a application for registration and fax or mail documentation to confirm an appropriate manufacturer registration with FDA. Please note in order to register as a Pennsylvania pharmaceutical manufacturers/repackager, the facility must also physically manufacturer, compound, or produce product at the location on the physical address on the application, which may be subject to inspection as well as meet personnel and other requirements. Virtual manufacturers do not qualify for registration but may obtain a certificate of record if desired. (See Certificate of Record requirements). Lastly, all businesses operating in the Commonwealth must also be properly registered to do business in Pennsylvania with the Department of State, Bureau of Corporations.
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    Do consultant firms assisting registrants or licensees need to file with the Department of Health?
    Registrants or Licensees who have contracted with a consulting firm to provide regulatory services or licensing application and renewal services should submit a power of attorney or similar documentation in writing notifying the consultant has the authority to act on their behalf and to the extent of that authortiy including mailing an billing addresses. The letter should include the licensee's or registrant's certificate number and address as well as name, title, an contact information for the facility/company person authorizing the authority. The letter must be direct from the registrant or licensee, not the consulting firm.
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    Is Oxygen a prescription drug?
    Medical gases (i.e. oxygen, carbon dioxide, helium, nitrous oxide, medical air, and combination of theses) used in human consumption are drugs within the meaning of section 201(g)(1) of the Federal Food, Drug, Device, and Cosmetic Act and the Pennsylvania Controlled Substance, Drug, Device, and Cosmetic Act section 2(b). Furthermore, pursuant to section 503(b)(1)(A) of the Federal Food, Drug, Device, and Cosmetic Act medical gases are required to be dispensed by prescription. The Federal Food and Drug Administration at www.fda.gov has additional information on oxygen.
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    Are dental laboratories required to be registered?
    Dental laboratories which are located within the Commonwealth of Pennsylvania and which are not operating under the immediate supervision of a licensed dentist must be registered with the Pennsylvania Department of Health and adhere to requirements under the Pennsylvania Controlled Substance, Drug, Device, and Cosmetic Act and the Pennsylvania Code of Regulations Title 28, Chapter 25, Controlled Substances, Drug, Devices, and Cosmetics.
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    What defines a change of ownership?
    Generally Change of Ownership means (i) an event in which the licensee sells or otherwise transfers its ownership to a different individual or entity, as evidenced by a change in federal employer identification number, or (ii) an event in which 51 percent or more of the ownership, shares, membership, or controlling interest of a licensee is transferred, or (iii) a change of business entity type or structure (i.e. S-corporation to Limited liability corporation, sole proprietorship to corporation). Change of ownership may involve mergers, transfers, outright sale or partial sale, stock exchanges, or change in legal entity. This is not a formal definition. For formal legal determination of change of ownership, please seek the advice of legal counsel.
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    Are Researchers required to be registered or licensed by the Department of Health to receive prescription pharmaceuticals and related products?
    Under Pennsylvania Controlled Substance, Drug, Device, and Cosmetic Act, researchers are authorized to receive prescription drugs and are exempt from registration or licensure as long as the research is within the scope of their professional approved research protocol practice. Generally this research is within a recognized scientific institution, governmental agency, or university. This exmeption does not apply to federal laws such as obtaining licensure from the federal Drug Enforcement Administration (DEA) to handle controlled substances. Note, a licensed distributor must perform due diligence and obtain verification documentation to ensure parties they shipped product to are authorized to receive it. This process includes researchers. Verification documentation is not limited to one type of documentation only. Examples include but are not limited to DEA license, veterinarian license, approved NIH protocol studies, and University research approval letters. Verification documentation should be able to show that the needed products are indeed within the scope of practice and research. Researchers must be able provide verification documentation to a licensed distributor in order for the licensed distributor to distribute prescription pharmaceuticals to them. If the pharmaceuticals involve controlled substances, then the researcher must specifically obtain a federal DEA research license prior to obtain controlled substances from a distributor. The Department of Health may be able to provide a letter of exemption in lieu of other documentation for special circumstances such as utilization of chorionic gonadotropin (a controlled substance under Pennsylvania law), one day pharmaceutical recycling programs, or other circumstances whereas individuals or facilities have legitimate need to possess prescription pharmaceuticals but do not have the standard documentation from a scientific institution, university, or other governmental agency. For more guidance check with your scientific institution or contracted distributor. If a letter of exemption is still needed, contact the Department of Health, Drug, Device, and Cosmetic Program for further information. For information regarding federal DEA research license, please contact DEA directly.
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    Is there a fee and what is the process to complete a verification form for another state?
    There is no fee at this time. However, we ask that you complete your portion of the form and maill the reuqest with appropriate form AND a pre-addressed return envelope. Verfication forms and requests can be sent to DDC, 132 Kline Plaza, Suite A, Harrisburg, PA 17104. Please allow a mnimum of 10 buisness days for processing
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    Will I receive a renewal notice when it is time to renew ny registration or license and when canI expect this form?
    As a courtesy, renewal notices/forms are automatically generated and mailed to the address on fiile approximately 5 weeks prior to expiration date of registration or license. While we make attempt to deliver these notices in a timely manner, we are not responsible for misdirected or lost mail. It is still ultimately the responsibility of the facility to renew their registration or license in a timely manner. If you do not receive a notice 4 weeks prior to expiration date, please feel free to contact our office for a copy or notice form. Third party consultants must submit Power of Atotrney or or authorization to receive notices, certificates, etc on behalf of a company.
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    Does an out of state medical device supplier need to register or be licensed?
    Out of state medical device manfuacturers or distributors only need register if they employ sales representatives in the Commonwealth of Pennsylvania. See general information under Out of state FAQ.
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    My Medical Device company is participiating in competitive bidding for CMS/Medicare. Do we need to register in Pennsylvania?
    Any retailer (direct to ultimate user/patient) of any medical device located in the Commonwealth of Pennsylvania must register with Department of Health except a licensed healthcare facility, pharmacy, or practitioner retailing devices within their respective scope of practice or license. MEDICAL DEVICES-OUT OF STATE: Any manufacturer, distributor, retailer of any medical device not located in the Commonwealth of Pennsylvania (OUT-OF -STATE) does NOT need to register UNLESS they employ sales representatives within the Commonwealth. See out of state FAQ for more information
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    Is there guidance on electronic prescribing in Pennsylvania?
    For more information please review the State Board of Pharmacy Special Notice Summary on technology and Automation on their website www.dos.state.pa.us/pharm "special notices" and review the full notice by the Board of Pharmacy in the Pennsylvania Bulletin (www.pabulletin.com) issue May 26, 2006. Also review the Department of Health notice in the Pennsylvania Bulletin (www.pabulletin.com) issue December 11, 2010 electronic prescribing. For federal controlled substance guidance visit www.deadiversion.doj.gov
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    How do I find out if there have been changes to a Pennsylvania statute or regulation?
    For statutes visit or review the legislature website for the latest proposed legislation and statutory amendments as well as recent enacted legislation or amendments at www.legis.state.pa.us For proposed regulation or regulatory amendments as well as recent adopted regulations review the PA Bulletin at www.pabulletin.com
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    Where can I get more information about electronic prescrbing or dispensing of controlled substances?
    Federal Drug Enforcement website provides information on the final rule as well as FAQ the general website is www.deadiversion.doj.gov an the FAQ for pharmacists is http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/pharmacies.htm
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    What are the application registration and/or license fees for pharmaceutical, controlled substance, API, medical devices, or cosmetic facilities ?
    PLEASE NOTE APPLICATION FEES ARE NONREFUNABLE REGARDLESS OF APPROVAL OR DENIAL OF APPLICATION. THEREFORE, PLEASE REVIEW LAWS, REGULATIONS, AND OTHER FAQ's PRIOR TO SUBMITTING APPLICATION. Fees can be reviewed on the application form under download/view application. Note only one fee, the highest amount, is due regardless of the number of applicable category types unless your business involves wholesale distribution of human prescription drugs, controlled substances, or API AND you are located in state then both, the distributor license and registration are due. Each location handling product in the Commonwealth requires a separate application and separate fee.
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    What are the Registration Requirements for Oxygen and/or Medical Gases?
    Oxygen and/or medical gases for medical purposes are considered prescription drugs under registration and licensure requirements. If a facility is manufacturing or transfilling oxygen or other medical gases, they must register as a Manufacturer of prescription products and apply for licensure. A facility that is purchasing and reselling filled oxygen units/cylinders to another facility or business must register as a Distributor of prescription products and apply for licensure. A facility selling filled oxygen units/cylinders directly to the ultimate user/patient only needs to register as a Distributor of prescription products (application for licensure is not required). Note: Registration as a Distributor of prescription products permits the handling and selling of other medical devices or durable medical equipment. Also: Transportation of oxygen may need a special registration with the public utility commission
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    Do I need to register if my company is only handling API (Active Pharmaceutical Ingredient)?
    Any in state manufacturer or distributor handling any substance recognized by the United States Pharmacopeia or National Formulary and whereas the substance is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal and to affect the structure or any function of the human or animal body shall register. This includes substances for use as a component of the aforementioned definition. Out of state facilities only need register if List I chemicals are being handled or they employ sales representatives in the Commonwealth.
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    What is a certificate or letter of record?
    Letter of record A letter of record is general recognition by the Department of Health of a business located in Pennsylvania that is performing specific activities related to pharmaceutical or medical industry but which does not handle any actual product at the address filed with the Department (i.e. a pharmaceutical manufacturer's headquarters). A letter of record is not a registration, license, or notice of free sale. A letter of record does not in any way attest to quality of any product or business practices of the entity nor does a letter of record give permission to a business to physically manufacture or distribute drugs at address on file for the record. A letter of record is a voluntary program and is not mandatory. Please see "how to obtain a certificate of record" for additional requirements.
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    How do I obtain a certificate or letter of record?
    Letter of record In order to obtain a letter of record, 1. the business must complete an application of record (found on our website under download applications) 2. complete the attestation that no product is being handled at the address on the application, 3. must have a verifiable Pennsylvania address where business is conducted, 4. must have and attach a D-U-N-S number and FDA- FEI number or FDA labeler code, 5. and must have current business documents filed with the Pennsylvania Department of State to conduct business in the Commonwealth.
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    How do I get a Verfication Form completed that another State is requesting?
    All verification or good standing requests should be mailed with pre-addressed envelope (the address where form or letter is to be mailed). Most states have a specific form to be completed. Complete your portion of the form and submit it to our office along with the pre-addressed envelope. If the state does not have a specific form, submit a written request for verification or good standing, including facility name and certificate number and contact information for person making the request. (Currently there is no fee for verification requests and turn around time is generally 14 days.) Mail to: PA Dept. of Health Drug, Device, and Cosmetic Program 132 Kline Plaza, Suite A Harrisburg, PA 17104 Please allow 10-15 business days for any request.
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