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Skip Navigation LinksPennsylvania Department of Health > Healthcare Facilities > Laws and Regulations > Drugs, Devices, Cosmetics
Drug, Device and Cosmetic Program
 

Any business in the Commonwealth of Pennsylvania who is manufacturing, distributing, or retailing drugs, medical devices, and/or medicated cosmetics must register with the Pennsylvania Department of Health unless otherwise noted as a designated exemption.

Important Note To Users: 
Due to the latest Payment Card Industry (PCI) security requirements, the Drugs, Devices and Cosmetic Program Registration web site will be updated to use only PCI-approved security protocols and standards on (date TBD).

However, these standards are compatible only with Windows 7 clients and higher. Users with Windows XP or earlier will be unable to connect to the web site
.
User Instructions for web browser configuration:
Internet Explorer (e.g. IE) running on Windows 7 and newer should work on web sites with TLS 1.0 disabled, including this site. However, support for TLS 1.1 and 1.2 may need to be activated in IE's Internet Options (see downloadable instructions below). Google Chrome and Mozilla Firefox should also work on Windows 7 and later versions.
IE (any supported version) running on Windows Vista and earlier will not work on web sites with TLS 1.0 disabled because these versions of Windows do not include TLS 1.1 and 1.2 security components.
The latest versions of Chrome and Firefox should work on Vista.

Download more detailed instructions here in Microsoft Word format or here as a PDF.

Regulations/Statutes:

Pennsylvania Controlled Substance, Drug, Device and Cosmetic Act

Pennsylvania Controlled Substance, Drug, Device and Cosmetic Regulations

Pennsylvania Non-Controlled Substances (List I) Registration and Reporting Act

Generic Drug Substitution/Equivalency Overview of Laws/Regulations

Pennsylvania State Board of Pharmacy - Laws & Regulations

Narrow Therapeutic Index General Information

Federal Requirements for Electronic Orders and Prescriptions

Pennsylvania Wholesale Prescription Drug Distributors License Act

 

​ ​NPLEx Information and Resources:

Click here to access the Appriss website

 

House Bill 602 Act 53 of 2013

NPLEx - National Precursor Log Exchange

PA NPLEx Registration Instructions

Letter of Notification for Act 53 of 2013

 

The information contained in this web site is being made available as a public service by the Pennsylvania Department of Health (Drug, Device, and Cosmetic Program). No posted information or material provided is intended to constitute legal or professional advice. The information contained in this web site was supplied from license/registration applications and other sources such as inspections, statutes, regulations and other governmental agencies. The Department of Health makes no representations or warranties, either express or implied, as to the accuracy of any posted information and assumes no responsibility for any errors or omissions contained therein. Furthermore, no warranty, express or implied, is created by providing information through this web site and the presence of a facility license or registration on the web site does not in any way constitute an endorsement by the Department of Health. No one shall be entitled to claim detrimental reliance on any views or information, whether provided by or accessed through this web site, or to claim any duty on our part to update posted information or to protect the interests of those accessing this web site. In no event shall the Department of Health, its contractors, or its member boards or staff be liable to you or anyone else for any decision made or action taken in reliance on such information or views. For more information regarding this web site or if you have any questions about information provided therein, please contact the Drug, Device, and Cosmetic Program of the Department of Health responsible for the license or registration directly. The data is derived directly from the Pennsylvania Drug, Device, & Cosmetic database and is updated on a daily basis.