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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 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 is Located Out-of-State?

*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's New?

*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 to a practitioner?

*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 are Pennsylvania's pedigree requirements?

*What are the regulations regarding the issuance of multiple CII prescriptions for the same controlled substance?

*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 to complete a verification form for another state?

*Will I receive a renewal notice when it is time to renew ny registration or license?

*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?

*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 of record?

*How do I obtain a certificate of record?

*How do I get a verfication form completed that is being requested by another State?

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    GENERAL INFORMATION
    Any business (each location) in the Commonwealth who is manufacturing, 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. In addition to the registration requirement, any distributor of prescription drugs, controlled substances, and/or medical gases 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 licensure registration. Again, any distributor of prescription drugs, controlled substances, and/or medical gases needs both registration and licensure.
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    Does an out of state 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.state.pa.us/pharm for current pharmacy requirements including for out of state pharmacies. Pharmacies that are acting beyond their scope of practice such as pharmacy businesses that are manufuacturing or distributing should review FAQ regarding out of state manufacturers or distributors.
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    Does a Pennsylvania licensed Pharmacy need to register with the Department of Health?
    Pharmacies may need to register/obtain licensure if they acting beyond their scope of pharmacy practice such as either/or: 1. The pharmacy is distributing quanity of drugs that is more than 5% of their inventory (see FAQ on pharmacies and distribution for more information) 2. The pharmacy is manufacturing drugs. (see FDA.gov for more information on manufacturing vs. compounding.) 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.
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    What are Some Examples of Medical Devices Requiring Registration?
    Manufacturer, distributor and/or retailer of medical devices within the Commonwealth must register. 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 such by the Federal Food and Drug Administration (FDA)
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    What if my Facility is Located Out-of-State?
    Registration may apply : Any out-of-state business that manufactures or distributes drugs or medical devices into the Commonwealth, is required to register ONLY if the out-of-state facility employs sales representatives within the Commonwealth 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. If virtual manufactuer is exempt from home state and federal licensing then DUNS registration must be submitted along with a letter identifying the exemption. Any out-of-state business (with no sales representatives) that manufactures 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 and is issued for in state facilities. Out-of-state mail order pharmacies or Internet pharmacies are not required to register with the PA. Department of Health; however, pharmacies should check with the Pennsylvania Board of Pharmacy at 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 business (other than practitioners-see FAQ) manufacturing, distributing, or retailing drugs or devices within the Commonwealth must register. If distributing prescription products, then licensure is also required. However, non-profit organizations can have the fee waived by sending a copy of their 501© form to us 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 produces, transfills, repackages, relabels, prepares, propagates, compounds, converts, or processes a controlled substance, drug, device, or cosmetic. A manufacturer who sells or ships prescription and/or controlled substances to another facility or business, unless owned by the same corporation, must also apply under the Licensure Act. A manufacturer or transfiller of oxygen/medical gases, selling all their products directly to the ultimate user or patient pursuant to a prescription order, does not need to apply for licensure. A manufacturer or transfiller of oxygen/medical gases selling their products to a healthcare facility or practitioner do need to apply for licensure
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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 storing, transferring, and acting as a distributor and should register as such under the Pennsylvania Drug, Device, and Cosmetic Act. T
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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 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, registration with the Pennsylvania Department of Labor and Industry is required (www.li.state.pa.us). For facilities handling veterinary/animal products, registration with the Pennsylvania Department of Agriculture may be required (www.pda.state.pa.us). For facilities handling the destruction of drugs or medical devices, registration with the Pennsylvania Department of Environmental Protection may be required (www.dep.state.pa.us). For General business or entreprenurial information in the Commonwealth, please check the Pennsylvania Department of Community and Economic Development (www.dced.state.pa.us) 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.state.pa.us). 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?
    A 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. 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). 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 product sas such as lip balms.
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    What's New?
    The Federal Governement has enacted a new law in November 2013 known as the Drug Quality and Securtiy Act. This law may affect manufacturers, compounders, and dsitributors of drugs/pharmaceuticals. Interested or affected parties should review the law, itself, and the FDA website for more guidance
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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 manufacturer of any drug product must employ a pharmacist, chemist, or other person with at least 5 years experience as qualified by scientific, technical, or educational training in the manufacturing of drugs. A distributor/wholesaler of prescription and/or controlled substance must employ a pharmacist, chemist, or other person with at least 3 years experience as qualified by scientific, technical, professional or educational training in the distribution and sale of drugs.
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    Pharmaceutical Compounding vs. Pharmaceutical Manufacturing
    NABP (National Association of Boards of Pharmacy) defines compounding as the preparation, mixing, assembling, packaging, or labeling of a drug or device as a result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice. In general, the dispensing of a pharmaceutical product to an individual patient for an individual patient needs who has presented a prescription would be considered compounding. It is generally prohibited to compound a commercially available product. For more information on pharmaceutical compounding vs. manufacturing visit the FDA website at www.fda.gov or contact the State Board of Pharmacy. Also note a new federal law was enacted known as the Drug Quality and Security Act on November 2013 that creates a special category known as an outsourcing facility to bulk compound sterile products as well as restating certain requirments. Interested or affected parties should review the law itself as well as again visiting the FDA website.
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    Can a pharmacy distribute drugs to a practitioner?
    A pharmacy may distribute minimal quantities to licensed practitioners under their pharmacy license provided that the sales do not exceed 5% annual prescription drug sales. If a pharmacy will be distributing more than 5% then the business must obtain a separate distribution registration and license. A distribution license and registration does not allow pharmacies to act as a distributor but rather a pharmacy can own a distribution business. All inventory, records, transactions, etc. are to be kept separate from the pharmacy. The following laws and regulations may provide more information for interested parties: Federal Prescription Drug Marketing Act (PDMA), Federal Controlled Substance Act, Pennsylvania Wholesale Prescription Drug Distributors License Act, and The Pennsylvania Controlled Substance Drug, Device, and Cosmetic Act and Regulations, and the Federal Drug Quality and Security Act. Pharmacies may also want to contact DEA for more information regarding distribution of controlled substances and/or List I chemicals
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    Where can I find information on the pseudoephedrine sales restrictions?
    On March 6, 2006 the Federal USA Patriot Improvement and Reauthorization Act of 2005 (HR 3199) was signed into law. 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. You may visit www.fda.gov/cder/news/methamphetamine for general information and overview of the law. The actual law can be viewed at: http://thomas.loc.gov or http://www.govtrack.us enter bill “HR3199”. Click text and view Title VII. The law is overseen by Federal U.S. Department of Justice, Office of Attorney General (http://www.usdoj.gov); therefore, you may wish to contact them for more information. The law goes into full effect on September 30, 2006 In addition Pennsylvania passed Act 107 signed November 23, 2010 which also restricts the sale and access to pseudoephedrine and provides for criminal penalties for failing to do so under Pennsylvania law. Interested parties may view this law and recent Pennsylvania laws under enacted legislation at www.legis.state.pa.us
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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.
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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 acting beyond their scope of practice. Furthermore, Pennsylvania does not currently issue separate controlled substance licenses. 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
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    What are Pennsylvania's pedigree requirements?
    PEDIGREE REQUIRMENTS Pennsylvania require that a drug distributor shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include the following information: (i) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped. (ii) The identity and quantity of the drugs received and distributed or disposed. (iii) The dates of receipt and distribution or other disposition of the drugs. Additionally Pennsylvania law requires compliance with all applicable federal laws including the current Pedigree requirements under the Federal Prescription Drug Marketing Act of 1987 as amended in 1992. For more information on the Federal requirements, please visit www.fda.gov Final note, the legislative bodies of Pennsylvania do periodically introduce legislation that may impose further restrictions or requirements of licensees. Therefore, the Drug, Device, and Cosmetic Program strongly recommends interested parties monitor the Pennsylvania legislative website www.legis.state.pa.us or speak to their representative for the latest legislative actions on this and related issues.
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    What are the regulations regarding the issuance of multiple CII prescriptions for the same controlled substance?
    The Pennsylvania Controlled Substance, Drug, Device, and Cosmetic Act does not address the subject matter of multiple CII prescriptions and therefore it is silent on this issue. The Act, like Federal law, does prohibit refills of CII drugs. The Federal law is found in the Code of Federal Regulations. A summary is listed: CODE OF FEDERAL REGULATIONS Sec. 1306.12 Refilling prescriptions; issuance of multiple prescriptions. (a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. (b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met: (i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice; (ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription; (iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; (iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and (v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law. (2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so. 3. Section 1306.14 is amended by adding a new paragraph (e) to read as follows: Sec. 1306.14 Labeling of substances and filling of prescriptions. * * * * * (e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date. Published Federal Register November 19, 2007 Effective December 19, 2007 NOTE: THESE REGULATIONS DO NOT WAIVE THE REQUIREMENT THAT THE ORIGINAL ISSUANCE DATE TO BE WRITTEN ON EACH PRESCRIPTION.
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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 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 submit a pre-addressed return envelope. Verfication forms and requests can be sent to DDC, 132 Kline Plaza, Suite A, Harrisburg, PA 17104
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    Will I receive a renewal notice when it is time to renew ny registration or license?
    As a courtesy, renewal notices 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.
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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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    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 of record?
    A certificate of record is general recognition by the Department of Health of a business located in Pennsylvania that is performing 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 certificate of record is not a registration, license, or notice of free sale. A certificate of record does not in any way attest to quality of any product or business practices of the entity nor does a certificate of record give permission to a business to manufacture or distribute drugs. Please see "how to obtain a certificate of record" for additional requirements.
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    How do I obtain a certificate of record?
    In order to obtain a certificate of record, the business must complete an application of record including the attestation that no product is being handled at the address on the application, must have a verifiable Pennsylvania address where business is conducted, must have a D-U-N-S number and/or FEI number, and must have current business documents filed with the Pennsylvania Department of State to conduct business in the Commonwealth. (See "What is a certificate of record?" FAQ for more information.)
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    How do I get a verfication form completed that is being requested by another State?
    Obtain the appropriate verification form from the requesting State. Complete your business information on the form. Mail to the Pennsylvania Department of Health Drug, Device, and Cosmetic Program 132 Kline Plaza, Suite A Harrisburg, PA 17104 along with a pre-addressed envelope (with address where you would like form mailed)
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