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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?

*Does a nonresident/out of state manufacturers, 503Bs, NDA holders, repackager, or relabeler of pharmaceuticals or API located in U.S but not in Pennsylvania need to register?

*What if my Business is a Charitable Organization?

*When should I expect to receive my certificate of registration or license after I submit my new application or renewal application?

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

*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 distributing cosmetics?

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

*What is the Noncontrolled Substance Registration and Reporting Act?

*Does a nonresident/out of state pharmaceutical, device distributor, reverse distirbutor, DME, or third party logistics facility located in U.S but not in Pennsylvania need to register?

*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?

*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 my registration or license and when can I expect this form?

*My Medical Device company is participiating in competitive bidding for CMS/Medicare. Do we need to register 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 Registration Requirements for Oxygen and/or Medical Gases?

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

*Does a licensed practitioner (ie physician, dentist, etc) need to obtain a separate state controlled substances license from the Department of Health in addition to their federal DEA license to prescribe controlled substances?

*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?

*Does an in state virtual drug manufacturer need to be registered or licensed with the Pennsylvania Department of Health?

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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 engaged solely in practice of pharmacy do not need to register or obtain licensure with the Department of Health. Pharmacies are regulate by the state Board of Pharmacy. However, if the business or individuals within are engaging in activities involving drugs or devices that are beyond the scope of pharmacy practice, the business may need to register or obtain licensure to engage in such activities. Examples may include but not limited to: 1. Wholesale Distribution 2. Manufacturing or compounding drugs, not for a specific patient or prescription order. (see FDA.gov for more information on manufacturing vs. compounding, 503B activities, before contacting the Department) 3. Operating as a retailer of over-the-counter drug products when no pharmacist is on duty. 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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    Does a nonresident/out of state manufacturers, 503Bs, NDA holders, repackager, or relabeler of pharmaceuticals or API located in U.S but not in Pennsylvania need to register?
    Nonresident manufacturers, 503Bs, NDA holders, repackager, or relabeler of pharmaceuticals or API located in U.S but not in Pennsylvania only need to register if they have sales representatives physically working or operating in the Commonwealth (i.e. "boots on the ground in the Commonwealth") or are shipping product containing a list I chemical (i.e. Sudafed®/ Pseudoephedrine, GHB, etc.). Licensure is not required as licensure is for in state only. If shipping List I chemical product, the location actually shipping the product is required to register, not a virtual or “headquarter only” location. If required to register (due to sales representatives or list I chemical) or voluntarily wish to apply, the manufacturer, 503B, NDA holder, relabeler, or repackager must complete application with fee or in lieu of fee- application with names of individual sales representative working in Pennsylvania. All applicants must complete application and submit or attach 1. Home state license/registration for manufacturing, 503B, NDA holder, repackager, or relabeler or letter from home state licensing agency noting exemption and reason exempt from home state license/registration, 2. FDA facility establishment registration/number and/or FDA labeler code. If label code only, name and location of contract manufacturer. 3 . DUNS and Bradstreet registration number. 4. Home state or federal wholesale distribution license if applicable Address for 1-4 must match address on application. 5. Additional information may be required. Please ensure contact information is accurate. Additional notes: Please note, nonresident Pharmacies or entities engaged in the practice of pharmacy should contact the Pennsylvania Department of State, Board of Pharmacy (www.dos.pa.gov/pharm) for more guidance on nonresident pharmacy licensure, practice of pharmacy questions, or compounding not exempt under federal 503b exemption. Please note, facilities handling list I chemicals not classified as a pharmaceutical or active pharmaceutical ingredient (API) by the FDA should download and complete the Non-controlled Registration and Reporting Application and review the Pennsylvania Non-controlled Registration and Reporting Law.
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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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    When should I expect to receive my certificate of registration or license after I submit my new application or renewal application?
    You should expect to receive your certificate of registration or license within 30 days OR you should be contacted by a Department representative requesting additional information or to schedule an onsite inspection. If you have neither received your new ceritifcate nor have been contacted by the Department, please contact the program directly. Please note, the program s not responsible for misdrected mail, email, or faxes.
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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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    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 distributing cosmetics?
    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, adhere to federal labelling requirements, and ensure policies/procedures to prevent the distirbution of misbranded or adultered cosmetics. (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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    Does a nonresident/out of state pharmaceutical, device distributor, reverse distirbutor, DME, or third party logistics facility located in U.S but not in Pennsylvania need to register?
    Nonresident pharmaceutical or medical device distributors (including reverse distributors and third party logistics) located in U.S but not in Pennsylvania only need to register if they have sales representatives physically working or operating in the Commonwealth (i.e. "boots on the ground in the Commonwealth") or are shipping/ receiving product containing a list I chemical (i.e. Sudafed®/ Pseudoephedrine, GHB, etc.). Licensure is not required as licensure is for in state only. If required to register (due to sales representatives or list I chemical) or voluntarily wish to apply, distributors, DME, or 3PL's must complete application with fee or in lieu of fee, an application with specific names of individual sales representatives. All nonresident applicants must have and attach or mailed/faxed within 5 business days their home state and/or federal license/registration as a distributor. Address from home state or federal license/registration must match address on application. Additional information may be requested. Applications are available on our website. www.health.state.pa.us/ddc All pharmaceutical or medical device distributors must comply with federal law. Additional subcategory notes: Nonresident pharmacies: nonresident pharmacies or nonresident facilities engaging in practice of pharmacy should contact the Pennsylvania Department of State, Board of Pharmacy for more guidance on nonresident pharmacy licensure. Individual practitioners should contact the Pennsylvania Department of State, Bureau of Professional and Occupational Affairs (BPOA). www.dos.pa.gov Reverse Distributors: If distribution includes transporting medical or pharmaceutical waste, parties should contact the Pennsylvania Department of Environmental Protection to ensure compliance with related laws. (www.dep.pa.gov) Hospital Beds: If distribution includes bedding or upholstery, parties should contact the Pennsylvania Department of Labor an Industry to ensure compliance with related laws. (www.dli.pa.gov) List I Chemicals: if distribution includes list I chemicals not classified as a pharmaceutical or active pharmaceutical ingredient (API) by the FDA should download and complete Non-controlled Registration and Reporting Application and review the Pennsylvania Non-controlled Registration and Reporting Law DME billing Medicare: Out of state DME providers wishing to bill Medicare for DME supplies should visit www.palmettogba.com/nsc under the DMEPOS state licensure directory. Under Pennsylvania. see special notes.
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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 practitioners 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 information 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. 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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    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 **5 weeks *** prior to the certificate expiration date as a courtesy to the address on file. 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 3 weeks prior to expiration date, please feel free to contact our office for a copy of form. Third party consultants must submit Power of Atotrney or or authorization to receive notices, certificates, etc on behalf of a company. 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. Changes to ownership or type of category 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 my registration or license and when can I 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 3 weeks prior to expiration date, please feel free to contact our office for a copy of 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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    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. 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. 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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    How do I find out if there have been changes to a Pennsylvania statute or regulation?
    For statutes we recommend visited or reviewing 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 we recommedn visiting or reviewing 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 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 see FAQ on out of state/nonresdient manufacturers or distributors
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    Does a licensed practitioner (ie physician, dentist, etc) need to obtain a separate state controlled substances license from the Department of Health in addition to their federal DEA license to prescribe controlled substances?
    The Pennsylvania Department of Health does not issue individual practitioner controlled substance licenses. Practitoners should contact their respective licensing Board to ensure compliance with their scope of practice and any additional requirements.
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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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    Does an in state virtual drug manufacturer need to be registered or licensed with the Pennsylvania Department of Health?
    The Pennsylvania Department of Health does not license or registration virtual drug or device manufacturers located within the Commonwealth. However, virtual drug or device manufacturers located in the Commonwealth may voluntarily request a letter of record with record number upon completion of a record application (www.health.state.pa.us/ddc under download application) from the Pennsylvania Department of Health, Drug, Device, and Cosmetic Program. If engaging in activities in another state that requires documentation from a virtual drug or device manufacturer, you should check with that state as to their requirements but it may be helpful to provide or have readily available: 1. A Pennsylvania letter of record 2. A verification form (see FAQ on How to obtain..) 3. A FDA assigned drug or device labeler code, 4. A copy of FDA approval letter for New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA) for each new drug your facility anticipates manufacturing or a waiver from FDA that states this is not necessary. Or similar FDA documentation for medical devices. 5. A copy of the contract entered into with the contract manufacturer and/or FDA facility number for the physical manufacturing site. 6. DUNS and BRADSTREET Registration Number.
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