Pharmaceutical Firms | Washington State Department of Health – Washington State Department of Health

The following forms are required for completing the application process. Please download and print forms.
** The Washington Pharmacy Quality Assurance Commission discussed third-party logistic (3PL) providers at its March 2018 business meeting. The commission decided it will no longer license entities exclusively engaged in third-party logistics, as defined in 21 U.S.C. § 360eee(22). While the commission will not license third-party logistics providers (3PLs), 3PLs are federally required to report annually to the FDA.
WAC 246-907-030 – Fees
Note: — means there is no fee required.
Applicants for a controlled substance researcher must list the controlled substances to be used, the purpose for such use, and the names of the people authorized to access the controlled substances. The applicant must develop policies and procedures for the storage, security, accountability, as well as recordkeeping for the acquisition and disposition of the controlled substances. All applicants are subject to a site inspection before registration.
Personal Data Questions
Applicant must answer personal data questions. If there is a positive answer to the professional liability claims history question, the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If a case is pending, applicant must indicate status.
Process for Approving/Denying Applications
Credentialing staff members review the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in RCW 18.64.080 and WAC 246-863. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal Requirements
Controlled substance researchers must renew their registrations annually on or before May 31. Registrations may be renewed within 90 days of the expiration date.
A courtesy renewal notice will be mailed to registration location address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the registration expire.
A health care entity license is location- and owner-specific. A health care entity is an organization that provides health care services in a setting that is not otherwise licensed by the state to acquire or possess legend drugs. Health care entity includes a freestanding outpatient surgery center, a residential treatment facility, and a freestanding cardiac care center.
A health care entity does not include an individual practitioner’s office or a multipractitioner clinic, regardless of ownership, unless the owner elects licensure as a health care entity.
A health care entity must designate a Washington licensed pharmacist as pharmacist in charge as a full time employee or consultant. The pharmacist in charge shall have the authority and responsibility to assure that the area(s) within the health care entity where drugs are stored, compounded, delivered or dispensed are operated in compliance with all applicable state and federal statutes and regulations.
A health care entity license may include the authority to purchase, possess, administer, and dispense controlled substances.
All applicants are inspected before a license is issued and periodically to ensure compliance with laws and rules on purchasing, ordering, storing, compounding, delivering, dispensing and administration of controlled substances and/or legend drugs. Physical requirements for the areas of a health care entity where drugs are stored, compounded, delivered or dispensed shall comply with official United States pharmacopeia standards.
Background questions
Applicant must answer background questions related to the owners, partners, managers, etc. If there is a positive answer to the professional liability questions the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If a case is pending, applicant must indicate status.
Additional information/documents required
A health care entity that dispenses controlled substance prescriptions for more than a 24-hours supply must report to the Prescription Monitoring Program by registering at the Secure Access Washington portal.
A health care entity that does not dispense controlled substances to Washington State residents, must complete the No Dispensing of Controlled Substances (NDCS) registration form. The NDCS registration is at: www.wapmp.org. Look under the “WA Pharmacy/Prescriber Data Uploader” link in the menu on the left of the page and then the “No Dispensing of Controlled Substances” link. This form must be resubmitted with each license renewal.
Process for approving/denying applications
Credentialing staff member reviews the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in Chapter 18.64 RCW, and Chapter 246-904 WAC. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal requirements
Health care entity licenses are renewed annually on or before September 30 and may be renewed within 90 days of the expiration date.
A courtesy renewal notice will be mailed to licensee’s address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the license expire and accrue a late penalty.
Location or ownership changes
A change of location to a different address requires a new application and payment of original licensing fees, including control substance authority if applicable.
A change in the business structure or organizational structure such as a change from sole proprietorship to a corporation or a change of more than 50 percent of ownership in a corporation requires a new application and original licensing fees, including CSA. A change of location or ownership will require an inspection before a new license is issued.
An itinerant vendor or peddler registration permits the holder to vend or sell to the public nonprescription drugs or preparations for the treatment of disease or injury. The registration is location-, owner-, and vehicle-specific. Applicant must provide a list of drugs intended for distribution.
Applicants are inspected before a license is issued, and periodically to ensure compliance with laws and rules.
Change of location or owner requires a new application and initial inspection. This registration is not transferable.
Personal data questions
Applicant must answer background questions if any person associated with the applicant has had a professional license restricted, or been found guilty of a drug or controlled substance violation. If there is a positive answer to the professional liability questions, the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If a case is pending, applicant must indicate status.
Additional information/documents required
An itinerant vendor may not sell any quantity of ephedrine, pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or salts of isomers, if the total monthly sales of these products exceed 10 percent of the vendor’s total prior monthly sales of nonprescription drugs in March through October. In November through February, the vendor may not sell any quantity of ephedrine, pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or salts of isomers, if the total monthly sales of these products exceed 20 percent of the vendor’s total prior monthly sales of nonprescription drugs. For purposes of this section, “monthly sales” means total dollars paid by buyers.
Drug inventory records are required to be maintained for two years and available for inspection.
Process for approving/denying applications
Credentialing staff members review the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in RCW 18.64.047. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal requirements
Controlled substance other registrants must renew their registrations annually on or before September 30. Registrations may be renewed within 90 days of the expiration date. A courtesy renewal notice will be mailed to registration location address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the registration expire or late penalty.
A drug sample distributor is a manufacturer of any federal food and drug administration approved controlled substance, legend drug, or products requiring prescriptions in this state, which is distributed at no charge to a practitioner by a manufacturer or a manufacturer’s representative, exclusive of drugs under clinical investigations approved by the federal food and drug administration.
Applicants must provide a 24-hour telephone number and the name of the individual(s) who shall respond to reasonable official inquiries based on reasonable cause, regarding required records, reports, or requests for information pursuant to a specific investigation of a possible violation.
Applicants that are not able to provide a 24-hour telephone number must provide the addresses of sites in this state at which drug samples are stored by the manufacturer’s representative, and the names and addresses of the individuals who are responsible for the storage or distribution of the drug samples. The manufacturer shall annually submit a complete updated list of the sites and individuals to the department.
State license/credential verification
Applicants must list all states where they do or did hold credentials. This list must also include when the applicant has applied for a credential, even if a credential was not granted. The jurisdiction where the applicant is or was credentialed must complete and submit the verification form (PDF). The jurisdiction must send the completed form directly to the department.
Background questions
Applicant must answer background questions related to the owners, partners, managers, etc. If there is a positive answer to the professional liability questions the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If a case is pending, applicant must indicate status.
Additional information/documents required
Out-of-state wholesalers must provide:
Process for approving/denying applications
Credentialing staff member reviews the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in Chapter 60.45 RCW. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal requirements
Sample drug distributor registrations are renewed annually on or before September 30 and may be renewed within 90 days of the expiration date.
A courtesy renewal notice will be mailed to the registration holder’s address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the registration expire and accrue a late penalty.
Location or ownership changes
A change of location to a different address requires a new application and payment of original licensing fees, including CSA.
A change in the business structure or organizational structure such as a change from sole proprietorship to a corporation or a change of more than 50 percent of ownership in a corporation requires a new application and original licensing fees, including CSA.
In-state wholesalers must pass an inspection before a new location or change of ownership registration is issued.
Applicants for other controlled substance registration must be location and ownership-specific to legally possess and use controlled substances.
Applicant must provide a list the controlled substances to be used, the purpose for such use, and the names of the persons authorized to access the controlled substance.
Examples of persons or firms in this classification
Applicants are inspected before a license is issued, and periodically to ensure compliance with laws and rules.
Change of location or registrant requires a new application and initial inspection. This registration is not transferable.
Personal data questions
Applicant must answer personal data questions. If there is a positive answer to the professional liability claims history question, the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If a case is pending, applicant must indicate status.
Process for approving/denying applications
Credentialing staff members review the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in RCW 18.64.080 and WAC 246-863. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal requirements
Controlled substance other registrants must renew their registrations annually on or before September 30. Registrations may be renewed within 90 days of the expiration date. A courtesy renewal notice will be mailed to registration location address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the registration expire.
Note: the commission will no longer license entities exclusively engaged in third-party logistics, as defined in 21 U.S.C. § 360eee(22). While the commission will not license third-party logistics providers (3PLs), 3PLs are federally required to report annually to the FDA.
A wholesaler that sell legend drugs and nonprescription, or nonprescription drugs in this state must be licensed as a wholesale distributor. A “wholesale distributor” means anyone engaged in wholesale distribution of drugs, including but not limited to, manufacturers; repackers; own-label distributors; private-label distributors; jobbers; brokers; warehouses; including manufacturers’ and distributors’ warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions. Types of practice licensed in this category:
Wholesaler Application:
Manufacturer applications – apply to locations in Washington state that manufacturer pharmaceuticals or engage in virtual manufacturer practice in-state only
In-state wholesalers and manufacturers are inspected before a license is issued and periodically to ensure compliance with laws and rules.
Non-resident manufacturers that sell or distribute legend drugs and nonprescription, or nonprescription drugs in this state must be licensed as a Washington pharmaceutical wholesaler and as a legend drug sample distributor if sample drugs are distributed.
No license is required for the wholesale distribution of medical devices so long as no pharmaceuticals are involved.
State license verification
Applicants must list all states where they do or did hold credentials. This list must also include when the applicant has applied for a credential, even if a credential was not granted. The jurisdiction where the applicant is or was credentialed must complete and submit the submit the verification form (PDF). The jurisdiction must send the completed form directly to the department.
Background questions
Applicant must answer background questions related to the owners, partners, managers, etc. If there is a positive answer to the professional liability questions the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If the case is pending, applicant must indicate status.
Additional information/documents required
Out-of-state wholesalers must provide:
Process for approving/denying applications
Credentialing staff members review the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in Chapter 18.64 RCW, and Chapter 246-879 WAC. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal requirements
Pharmaceutical wholesaler and manufacturer licenses are renewed annually on or before September 30 and may be renewed within 90 days of the expiration date.
A courtesy renewal notice will be mailed to licensee’s address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the license expire and accrue a late penalty.
Location or ownership changes
A change of location to a different address requires a new application and payment of original licensing fees, including CSA.
A change in the business structure or organizational structure such as a change from sole proprietorship to a corporation or a change of more than 50 percent of ownership in a corporation requires a new application and original licensing fees, including CSA.
In-state wholesalers must pass an inspection before a new location or change of ownership license is issued.
Third Party Logistic Providers – 3PLs
The Washington Pharmacy Quality Assurance Commission discussed third-party logistic (3PL) providers at its March 2018 business meeting. The commission decided it will no longer license entities exclusively engaged in third-party logistics, as defined in 21 U.S.C. § 360eee(22). While the commission will not license third-party logistics providers (3PLs), 3PLs are federally required to report annually to the FDA.
A distributor or manufacturer of poisons must hold a license issued by the Department of Health, Pharmacy Quality Assurance Commission. Poison is defined as:
Poison distributor and poison manufacturer licenses are renewed annually on or before September 30 and may be renewed within 90 days of the expiration date.
State license verification
Applicants must list all states where they do or did hold credentials. This list must also include when the applicant has applied for a credential, even if a credential was not granted. The jurisdiction where the applicant is or was credentialed must complete and submit the verification form (PDF). The jurisdiction must send the completed form directly to the department.
Background questions
Applicant must answer background questions related to the owners, partners, managers, etc. If there is a positive answer to the professional liability questions the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If the case is pending, applicant must indicate status.
Additional information/documents required
Poison register – mandatory record before selling:
Process for approving/denying applications
Credentialing staff members review the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in Chapter 69.38 RCW. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal requirements
Poison distributor and poison manufacturer licenses are renewed annually on or before September 30 and may be renewed within 90 days of the expiration date.
A courtesy renewal notice will be mailed to licensee’s address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the license expire.
Location or ownership changes
A change of ownership or change of location to a different address requires a new application and payment of original licensing.
Applicants who are not wholesalers, manufacturers, or retailers must have a permit to sell, transfer or furnish any precursor substance. A precursor is a substance that is usable in the illegal production of a controlled substance. Applicants must provide a list of any substances that may be sold, transferred, received or furnished.
Applicants are inspected before a license is issued, and periodically to ensure compliance with laws and rules.
Change of location or change of ownership requires a new application and initial inspection. This permit is not transferable.
Personal data questions
Applicant must answer personal data questions. If there is a positive answer to the professional liability claims history question, the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If a case is pending, applicant must indicate status.
Additional information
Before selling, transferring, or furnishing a precursor substance to any person:
The permit holder that received precursor substances from any source outside the state of Washington will report the transaction within 14 days of receipt. The report (PDF) will include the following:
Process for approving/denying applications
Credentialing staff members review the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in Chapter 69.43 RCW and Chapter 246-889 WAC. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal requirements
Controlled substance other registrants must renew their registrations annually on or before September 30. Registrations may be renewed within 90 days of the expiration date. A courtesy renewal notice will be mailed to registration location address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the registration expire.
A shopkeeper registration is required for businesses (except licensed pharmacies) that sell any nonprescription drugs. These drugs must be in the original manufacturer’s packaging. Shopkeeper registration is processed through the business licensing system at the Department of Revenue.
A shopkeeper registration is required for businesses (except licensed pharmacies) that sell any nonprescription drugs. These drugs must be in the original manufacturer’s packaging. Shopkeeper registration is processed through the business licensing system at the Department of Revenue.
Restricted non-prescription/over-the-counter drugs
State law as well as federal law requires retailers who sell over-the-counter cold and allergy medicine containing ephedrine, pseudoephedrine, or phenylpropanolamine to restrict consumer access to these products by storing them behind the counter and reporting their sales to the National Precursor Log Exchange (NPLEx). No shopkeeper or its employee may sell, transfer, or furnish in a single transaction products containing a total of more than 3.6 grams of ephedrine, pseudoephedrine, or phenylpropanolamine, their salts, isomers, or salts of isomers, in any 24-hour period, or more than a total of nine grams per purchaser in any 30-day period.
After you have registered your business by completing the business license application, please set up an account to report your sales of cold and allergy medicine by completing the NPLEx (Methcheck) registration.
In addition, federal law requires sellers to self-certify with the Drug Enforcement Administration (DEA). For more information refer to Section IX of the DEA Chemical Handler’s Manual or contact the DEA at 888-219-1418.
A person making a retail sale of a finished drug product containing any quantity of dextromethorphan must require and obtain proof of age from the purchasers’ before completing the sale, unless from the purchaser’s outward appearance the person making the sale would reasonably presume the purchaser to be 25 years of age or older. Chapter 69.75 RCW.
Please note, a registered shopkeeper may sell from vending machines over-the-counter medications that have no sales restrictions. However, medications that are subject to any restriction on their sale e.g. age, quantity, or sales transaction tracking requirement, are not to be sold from a vending machine. If you have questions regarding this information, please contact the Pharmacy Quality Assurance Commission’s business office at 360-236-4834.
A humane society and animal control agency may apply to the department for registration for the sole purpose of being authorized to purchase, possess, and administer sodium pentobarbital to euthanize injured, sick, homeless, or unwanted domestic pets and animals. Any agency so registered shall not permit a person to administer sodium pentobarbital unless such person has demonstrated adequate knowledge of the potential hazards and proper techniques to be used in administering this drug.
All humane societies and animal control agencies are inspected before a registration is issued, and periodically to ensure compliance with laws and rules.
Background questions
Applicant must answer background questions related to the owners, partners, managers, etc. If there is a positive answer to the professional liability questions the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If a case is pending, applicant must indicate status.
Additional information/documents required
Written policies and procedures must be submitted with the application for registration. The policies and procedures must include:
A humane society or animal control agency must employ at least one person who has completed an approved training program or training that is substantially equivalent.
A humane society or animal control agency must designate a person responsible for maintaining all records and submitting all reports required by applicable law or rule. The designated person is also responsible for the ordering, possession, safe storage, and use of the sodium pentobarbital and approved legend drugs.
Process for approving/denying applications
Credentialing staff members review the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in chapter 69.50 RCW, and Chapter 246-886 WAC. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal requirements
Humane society and animal control agency registrations are renewed annually on or before May 31 and may be renewed within 90 days of the expiration date.
A courtesy renewal notice will be mailed to registration holder’s address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the registration expire.
Location or ownership changes
A change of location to a different address requires a new application and payment of original licensing fees.
A change in the business structure or organizational structure such as a change from sole proprietorship to a corporation or a change of more than 50 percent of ownership in a corporation requires a new application and original licensing fees, including CSA.
The Washington State Department of Fish and Wildlife (DFW) may apply to the department for registration to purchase, possess, and administer controlled substances for use in chemical capture programs. The registration names a primary registrant and physical address of where the drugs are stored. The registration is relevant to the named location and registrant. All applicants are subject to a site inspection before registration.
Controlled substances obtained under this limited registration are for veterinary use only.
Background questions
Applicant must answer background questions if any person associated with the applicant had a professional license restricted or was found guilty of a drug or controlled substance violation. If there is a positive answer to the professional liability questions, the applicant must send an explanation of the nature of the case, data and summary of care given, copies of the original complaint, and the settlement or final disposition. If a case is pending, applicant must indicate status.
Additional information/documents required
The DFW must notify the Commission in writing of the names of individuals who are authorized to possess and administer controlled substances.
Applicants must their federal Drug Enforcement Administration registration number.
Possession and administration of legend drugs and controlled substances are limited to DFW officers, biologists, and veterinarians who have successfully completed approved training. Approved drugs are listed under Chapter 246-886 WAC Chemical Capture.
Process for approving/denying applications
Credentialing staff members review the application and supporting documents to make an initial determination on eligibility. The recommendation is based upon the requirements outlined in chapter 69.50, 69.41 RCW and Chapter 246-886 WAC. Credentialing supervisors approve routine applications that don’t have positive answers to personal data questions, have questionable verifying documents or are otherwise “red flag” applications. “Red flag” applications are forwarded to the exception application process for determination by the appropriate disciplinary authority. An applicant will be formally notified of a denial and has the opportunity for a hearing to appeal the decision.
Renewal requirements
Washington Department of Fish and Wildlife Chemical Capture registrations are renewed every five years on or before September 30 and may be renewed within 90 days of the expiration date.
A courtesy renewal notice will be mailed to registration holder’s address of record. Renewals mailed to the department must be postmarked on or before the expiration date to avoid having the registration expire.
Location or registrant changes
A change in location where drugs are stored or primary registrant requires a new application.
For people with disabilities, Web documents in other formats are available on request. To submit a request, please contact us at civil.rights@doh.wa.gov.
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