Pennsylvania Department of Health - FAQs (Frequently Asked Questions)

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GENERAL INFORMATION
Any business (each location) in the Commonwealth that is physically manufacturing, compounding (503B), distributing, wholesaling, or retailing drugs (prescription, controlled substances , animal, or over-the-counter), medical devices, gases, cosmetics, and/or List I chemicals in accordance with the Controlled Substance, Drug, Device and Cosmetic Act (Act 233 of 1972)(DD&C Act) generally must register with the Pennsylvania Department of Health Drug Device and Cosmetic (DDC) program. Note, Pennsylvania licensed practitioners and healthcare facilities handling drugs or devices, pursuant to their scope of practice or licensure law, do not need to register separately with the DDC program and are generally exempt from registration (i.e. physician dispensing medications to his patients after medical evaluation, pharmacies dispensing drugs or devices pursuant to prescription order, etc). In addition to the registration requirement, any wholesale 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). Any Pennsylvania located wholesale distributor of human prescription drugs or controlled substances (i.e. actually handling product), needs both registration and licensure. Pennsylvania located Brokers or other entities not actually handling product are not required to registration or obtain licensure but should ensure shipping documentation is clear.
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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 including medical devices) is regulated by the Pennsylvania Board of Pharmacy not the Pennsylvania 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/nonresident pharmacies. Pharmacies that are acting beyond their scope of practice such as pharmacy businesses that are manufacturing, 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. This includes pharmacies dispensing medical devices. Pharmacies are regulated 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 or pharmacy license, 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 separate retailer of over-the-counter drug products when no pharmacist is on duty. 4. Operating a separate DME business. 5. Engaging in 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 physically handling actual FDA approved medica devices or equipment must register unless acting with scope of practice license (i.e. Physician providing medical devices directly to his/her patients, pharmacies dispensing devices to their patients, hospitals providing medical devices directly to their patients, etc). Please note, a medical device is generally defined as an instrument or apparatus and parts and accessories used to diagnose, cure, mitigate, treat, or prevent disease in man or animals or alter structure or function of man. Further, devices or equipment marketing and/or sold in the United States are generally defined and classified by FDA (see www.fda.gov CDRH section ) Some common examples but not all-inclusive list of medical devices and facilities that may require registration: Dental laboratories, optical laboratories, durable medical equipment (DME) facilities, eyeglasses/contacts retailers, prosthetics and orthotics, specialized footwear, braces, canes, wheelchairs, incontinence pads, etc. Note, PERS (personal emergency alert systems) are not defined or classified as medical devices by FDA and thus not regulated by the Pennsylvania Department of Health, Drug & Device Program. 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 a drug 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, or medical devices located in U.S but not in Pennsylvania need to register?
Nonresident pharmaceutical or medical device distributors (including reverse distributors and third party logistics, but not retail/direct to consumer) 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. REGISTRATION WITH PENNSYLVANIA DEPARTMENT OF HEALTH DRUG & DEVICE PROGRAM IS NOT REQUIRED FOR OUT OF STATE FACILITIES ENGAGED IN RETAIL SALES ONLY (i.e. direct to consumer/user). If required to register (due to sales representatives or list I chemical) or voluntarily wish to apply, all nonresident applicants must submit within 5 business days their home state and/or federal license/registration. If handling Bulk List I chemicals/unfinished goods or non-pharmaceutical List I Chemicals-please contact the Department for more requirements/guidance.
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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-C documentation to us at the time of new application and renewal of registration at: PA Department of Health Drug & Device Registration/DDC 2525 North 7th Street Suite 210D Harrisburg, PA 17110 or by fax (717) 231-4790. Applications for Registration can then be completed under the fee-exempt status. An official certificate will not be mailed until the 501-C 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?
Generally, most certificate of registration or license will be issued within 15 business days, however, you may be contacted by a Department representative requesting additional information/documentaiton or need to meet additional requirements and/or onsite inspection. If you have neither received your new certificate nor have been contacted by the Department, please contact the program directly. Please note, the program is not responsible for misdirected mail, email, or faxes and fees may be nonrefundable. If onsite inspection or other documentation is required, your application may need such additional documentation or inspection prior to issuance which may take up to 60 days. If you do not respond to such requests, an application may be cancelled.
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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, canes, foot braces, 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 you license or register in state virtual distributors, brokers, or billing agents?
No. We only register or license in state facilities actively engaged in manufacturing, distribution, retailing, storage and physically handling of actual product at the location in Pennsylvania.
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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 directly shipping products containing a List I chemical (ie pseudoephedrine, GHB, etc) Commercial Warehouses or Third Party Logistics (3PL) should also review the federal Drug Quality and Supply Act for possible licensure requirements and other compliance requirements.
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What Other Drug or Device Registrations may I possibly 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 radiologic equipment, registration may be required with the Pennsylvania Department of Environmental Protection. (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 entrepreneurial 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 Non-Controlled 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 provide further guidance 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 includes producing, preparing, propagating, compounding, processing, repackaging, or relabeling. Cosmetic facilities must maintain sanitary conditions, proper recordkeeping, adhere to federal labelling requirements, federal safety substantiation, federal adverse reaction reporting, and ensure policies/procedures to prevent the distribution of misbranded or adulterated cosmetics. (see www.fda.gov). Larger Cosmetic manufacturers may be required to also register and list their products with the FDA and meet additional requirements. See 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 product, registration with FDA, and adherence to GMP (good manufacturing practices). Visit the FDA website under cosmetics and under drugs for further information. FDA's article “Are all personal care products regulated as cosmetics?” on their website may be helpful with regards to specific products such as lip balms. Regarding soap versus cosmetics- FDA website may provide further guidance on soap vs. cosmetic vs. drug at: 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 inclusive, 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 or Drug Quality and Security 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 Precursor 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 into Pennsylvania. No fee is applied, only registration and reporting are 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 distributor, 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, not retail/direct to consumer) 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. REGISTRATION I WITH PENNSYLVANIA DEPARTMENT OF HEALTH DRUG & DEVICE PROGRAM IS NOT REQUIRED FOROUT OF STATE FACILITIES ENGAGED IN RETAIL SALES ONLY (i.e. direct to consumer/user). If required to register (due to sales representatives or list I chemical) or voluntarily wish to apply, distributors, 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. All nonresident wholesale distributors of human prescription drugs should be listed under the federal wholesale distributor database. 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-direct to consumer/retailers/ billing Medicare: Out of state DME providers retailing only should visit https://palmettogba.com/palmetto/npewest.nsf/DID/P4LF7PNQM8?Open&emb=PA under the DMEPOS state licensure directory or Novitas (www.novitas-solutions.com) See special notes. OUT OF STATE DME/MEDICAL DEVICE RETAILERS (i.e. direct to consumer) DO NOT NEED TO REGISTER WITH THE PENNSYLVANIA DEPARTMENT OF HEALTH. All nonresident facilities are expected to comply with applicable federal laws
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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 certified chemist, or other person with at least 3 years documented verifiable experience as qualified by scientific, technical, professional or educational training specifically 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 and photo identification. 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 verifiable 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 commercially 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 visit the FDA website (www.fda.gov) or review the aforementioned laws. The Pennsylvania 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 manufactured 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, OR to fulfill a specific patient need,(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, exceed 5% distribution, or to distribute to other pharmacies or distributors. Both federal and state laws clearly outlined a limited exemption for a licensed pharmacy to distribute, however, this exmeption under the federal and state laws never intended for a pharmacy to act as a wholesaler. Thus, a wholesale Distributor license and 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. (i.e not drop ship). 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 directly from licensed distributors or manufacturers, not pharmacies. 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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How do I notify the Department of change in designated representative or qualified supervisor for manufacturer or distributor?
Notify our office of designated representative or qualified supervisor within 15 business days in writing – the information can be faxed to us (fax 717-231-4790), email to ra-ddc@pa.gov or mailed to the PA. Dept of Health, Drug & Device Section, 2525 North 7th St, Suite 210D Harrisburg, PA 17110. For in state facilities, include your certificate number and qualifications of designated representative or supervising manager (i.e. pharmacist license, resume with verifiable and qualifying experience, etc), photo identification, criminal background and effective date of change.
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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 in writing – the information can be faxed to us (fax 717-231-4790) or email to ra-ddc@pa.gov or mailed to the PA. Dept of Health Drug & Device Section, 2525 North 7th Street, Suite 210D, Harrisburg, PA 17110 – include your certificate number plus your old and new address/business name as well as effective date of changes. 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. NOTE: For in-state wholesale prescription drug distributor contact the Department as onsite inspection and additional documentation may be required. 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 cover letter with application, or send email ra-communityprogramlicensure@pa.gov if submitting online regarding the change and reference original registration number. Submit within 15 business days after the change of ownership. A new certificate of registration number and if applicable license as well will be issued and mailed. Please note, in-state wholesale drug distributors may need onsite inspection and submission of additional data prior to approval Contact Department (717-787-4779) for more information. OUT OF STATE OR FEDERALLY LICENSED FACILITIES: Must submit a copy of their home state license or federal license reflecting the change or updates. (i.e obtain updated home state or federal license first). Also see: What defines a change of ownership?
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How do I renew my registration/license?
Renewal notices are mailed approximately 4 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 2 weeks prior to expiration date, please feel free to contact our office for a copy of form. Third party consultants must submit Power of Attorney 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 717-231-4790. The form may also be mailed to our office - PA. Dept of Health, Drug, Device, & Cosmetic program, 2525 North 7th Street, Suite 210D, Harrisburg, PA 17110 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 717 787-4779
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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 prescribing 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 orthotists and prosthetist acting not directly under a licensed physician or healthcare facility
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What is required to register an in state pharmaceutical manufacturer or repackager facility?
Interested parties must complete an application for registration and if applicable wholesale license application AND fax or mail documentation to confirm an appropriate manufacturer registration with FDA. If your FDA registration is pending or has not yet been obtained, please do not submit application as it will be returned to you as incomplete. 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 authority including mailing an billing addresses. The letter should include the licensee's or registrant's certificate number and address as well as name, title, and 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 generally required to be dispensed by prescription or distributed only to those authorized by law to receive medical gases. 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 licensed or registered business sells or otherwise transfers its ownership to a different individual or entity, as evidenced by a change in federal employer identification number (FEIN), or (ii) an event in which 51 percent or more of the ownership, shares, membership, or controlling interest of the specific licensee or registrant business 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. Changes in federal license or home state (for out state facilities) may require submission of new application. Generally indirect changes at grandparent or great-grandparent level whereas no changes have occurred at facility or registrant/licensee level (i.e. no change in FEIN, no change in federal license, etc.) then a new application is not required. This is not a formal definition. For formal legal determination of change of ownership, please seek the advice of legal counsel. Also see: What do I do if our business undergoes a change of ownership?
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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, the research being conducted is or will be within a recognized scientific institution, governmental agency, or university. This exemption 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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Does an out of state medical device/equipment or medical gas retailer, mail order, (i.e.direct to consumer seller) need to register?
NO. Out of State retailer/Direct to consumer sales/delivery of medical devices/equipment or gases does not require registration, regardless of sales or marketing. However, said entities must comply with federal law and general consumer protection laws. Out of state Pharmacies dispensing medical devices to patients under their pharmacy license may need to register with Pennsylvania Board of Pharmacy (www.dos.pa.ogv/pharm) Note: Out of State manufacturers and/or distributors/wholesalers ( i.e. selling to practitioners/healthcare facilities) of FDA approved medical devices/equipment- see manufacturer or distributor FAQ.
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RENEWAL: Will I receive a renewal notice when it is time to renew my registration or license and when can I expect this form? What if a consultant is handling the company's license renewals?
As a courtesy, renewal notices/forms are automatically generated and mailed to the address on file approximately 4 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. Please note, a facility cannot renew more than 5 weeks prior to expiration date. Pin numbers generally remain the same from year to year. If you do not receive a notice 3 weeks prior to expiration date, please feel free to request a copy of form to be faxed or remailed to your organization by emailing ra-ddc@pa.gov with subject: DDC RENEWAL FORM and in email provide: your name, facility name, registration and/or license number, AND FAX NUMBER . Third party consultants must submit or file Power of Attorney or similar authorization/documentation to receive notices, certificates, etc and act on behalf of a company with regards to registrations/licenses unless already filed with the Department.
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Do in-state drop shippers, virtual distributors, brokers, or billing agents need to be registered?
No, only in state drug or device manufacturers, distributors, and retailers that are physically receiving/handling product at the Pennsylvania location/warehouse/storefront need to be registered with the Pennsylvania Department of Health, Drug, Device, and Cosmetic Program. The program does not oversee or register in state virutal distributors, drop shipper only, brokers only, paper only offices, or billing/invoicing agents. All enitties should ensure compliance with applicable federal laws and ensure paperwork/invoicing is transparent and not misleading to consumers.
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My Medical Device company is participating in competitive bidding for CMS/Medicare. Do we need to register in Pennsylvania?
Any retailer (direct to ultimate user/patient) of a FDA classfied medical device physically LOCATED in the Commonwealth of Pennsylvania and physically handling product 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 https://palmettogba.com/palmetto/npewest.nsf/DID/P4LF7PNQM8?Open&emb=PA or Novitas at www.novitas-solutions.com Under Pennsylvania. See special notes. MEDICAL DEVICES-OUT OF STATE: Nonresident retailer of medical devices do not need to register regardless of employment of sales representatives. See out of state FAQ for more information NOTE, the Department of Health Drug & Device program does not register or icense in state virtual, brokers, drop shippers, or billing only agents.
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Does the Pennsylvania Department of Health Drug Device and Cosmetic program oversee or regulate tattooing, microblading, or permanent applied/tattooed cosmetics?
No
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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 recommend visiting or reviewing the PA Bulletin at www.pabulletin.com
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Where can I get more information about electronic prescribing or dispensing of controlled substances?
Federal Drug Enforcement website provides information on the final rule as well as general FAQ and FAQ specifically for pharmacists, their general website is www.deadiversion.doj.gov On state level for more guidance on electronic prescribing of controlled substances contact: Pennsylvania Department of Health Attn: Drug Surveillance and Misuse Prevention Office 625 Forster Street, 6th Floor Harrisburg, PA 17120 Email: RA-DH-PDMP@pa.gov, phone 1-844-377-7367 FAQS for Act 96: https://www.health.pa.gov/topics/Documents/Programs/PA_EPCS_FAQ.pd
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Do in state billing/invoicing offices for medical devices/DME need to register?
No. The Pennsylvania Department of Health, Drug & Device Program only registers facilities, storefronts, or warehouse physically handling FDA approved product at the Pennsylvania location (i.e. receiving, storing, handling etc.). The Pennsylvania Department of Health, Drug & Device Program does not oversee in state virtual, Billing only/invoicing only locations or "'paper" headquarters. Such entities are encouraged to ensure their paperwork clearly notes where product is "shipped from" vs. "Billed to". The Pennsylvania Department of Health, Drug & Device Program does not oversee devices not classified by FDA as a medical device (ie PERS are not classified as a medical device and thus not overseen by the program).
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What are the Registration Requirements for Oxygen and/or Medical Gases?
Oxygen and/or medical gases for medical purposes are generally considered prescription drugs under state and federal law. If a facility is manufacturing or transfilling oxygen or other medical gases in the Commonwealth, they must register with the Department of Health as a Manufacturer of prescription drugs and register with the Federal Food and Drug Administration (FDA). A facility that is purchasing and reselling filled oxygen units/cylinders to another facility or business or that is supplying medical gases directly to the ultimate user must register as a Distributor of prescription products. Licensure as a wholesale distributor is not required. Individual Practitioners, pharmacies, and other healthcare facilities such as hospitals and nursing homes licensed by their respective practice or healthcare facility laws, do not need to register if dispensing oxygen to their own patients. Note: Registration as a Distributor of prescription products/medical gases permits the handling and selling of other medical devices or durable medical equipment. Licensure is generally only required to handle prescription drugs other than medical gases. 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 and said substance is intended for the manufacturer of an FDA approved commercial drug in the U.S. shall register. This includes substances for use as a component of the aforementioned definition. Out of state facilities see FAQ on out of state/nonresident manufacturers or distributors. If the substance is also a List I chemical , please contact the Department for more guidance.
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Does a licensed practitioner (i.e. 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. Practitioners 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 recognized by the Federal government (generally FDA) 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 5.must have FDA- FEI number or FDA labeler code, 6. 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 formal verification or letter of good standing for my Pennsylvania drug or device registration?
All verification or good standing requests should be mailed with pre-addressed envelope included with the request (i.e.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, note such in the request letter. Please include facility name, certificate number, and contact information for person making the request. (Currently there is no fee for verification requests and turn around time is generally 15 business days.) Mail to: PA Dept. of Health Drug, Device, and Cosmetic Program Attn: Verification 2525 North 7th Street, Suite 210D Harrisburg, PA 17110 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 register a virtual drug or device manufacturers located within the Commonwealth. However, virtual drug or device manufacturers located in the Commonwealth and recognized by federal government (ie FDA) may voluntarily request an official 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/ All applications are subject to review and verification of certain documentation (ie FDA label code, business filings etc.). 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 other FAQ on How to obtain a formal verification?) 3. A FDA assigned drug or device labeler code, 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. Additionally, the National Association of Board of Pharmacies (NABP) offers an inspection and accreditation program for virtual manufacturers. Contact them directly if interested.
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