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The Alabama Board of Pharmacy issues the following types of business permits. Click on which business pertains to you for more information. Please note that all Alabama Board of Pharmacy permits are operational-specific. Please read the definitions of each facility type before making your selection.
MANUFACTURER
A person or entity, except a pharmacy, who prepares, derives, produces, researches, tests, labels, or packages any drug, medicine, chemical, or poison.
WHOLESALE DRUG DISTRIBUTOR
A person (other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or re-packager) engaged in the business of distributing drugs and medicines for resale to pharmacies, hospitals, practitioners, government agencies, or other lawful outlets permitted to sell drugs or medicines.
REPACKAGER
A person who purchases or acquires from a manufacturer or distributor, a drug, medicine, chemical, or poison for the purpose of bottling, labeling, or otherwise repackaging for sale or distribution. This definition shall not apply to a physician licensed to practice medicine who as a part of his or her professional practice dispenses, administers, sells or otherwise distributes any drug to a patient.
THIRD PARTY LOGISTICS (3PL)
An entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.
PRIVATE LABEL DISTRIBUTOR
A firm that does not participate in the manufacture or processing of a drug but instead markets and distributes under its own trade name, and labels a drug product made by someone else. The private label distributor is responsible for the products it introduces into interstate commerce and for compliance with FDCA requirements and cGMP regulations.
OXYGEN MANUFACTURER/WHOLESALER
PRECURSOR
A chemical substance specifically designated as such by the Alabama State Board of Pharmacy that, in addition to legitimate uses, is used in the unlawful manufacture of a controlled substance or controlled substances.
RETAIL MEDICAL OXYGEN
Any person, company, agency, business or entity of any kind which sells or provides medical oxygen directly or Indirectly to patients or consumers and which bill the patient or consumer or their insurance, Medicare, Medicaid or other third-party payor for the sale or providing of medical oxygen must obtain a Retail Medical Oxygen Permit from the Alabama State Board of Pharmacy.
503B OUTSOURCING FACILITY
A facility at one geographic location or address that is engaged in the compounding of sterile drugs, which has elected to register with the federal Food and Drug Administration as an outsourcing facility and complies with the requirements of Section 503B(d)(4)(A) of the federal Food, Drug, and Cosmetic Act.
Reinstatement/Late Renewal
Retail Medical Oxygen Reinstatement Form—email tking@albop.com
For late renewals of all other facilities, email sgamble@albop.com
Pay Fee/Fine
Click here to log in to profile and pay fee/fine.
Change of Ownership
Change of Name and/or Address
Designated Representative Forms
Additional Forms
Print Permit
Click here to print your facility permit
Frequently Asked Questions
New Applications:
- How long does the new application process take?
- The average processing time for new applications is 90 business days.
- Will I receive a notice that my application is being processed?
- If you would like to know what day your application is received in our office, we recommend sending it using a carrier that offers an option for tracking.
- A cursory review of your application will be completed within 7-10 business days of receipt. If the application is complete an email will be sent to the application contact person confirming receipt of the application and details regarding further review. If your application is not accepted for processing, it will be mailed back to the application contact person with a letter of explanation.
- During the review process if our office has any questions or concerns regarding your application, ALL communications will be with the application contact person only. We do not provide repeated status updates.
- If you would like to know what day your application is received in our office, we recommend sending it using a carrier that offers an option for tracking.
- I received a new application deficiency notice, what does that mean?
- During our review process we found that your application was missing documentation or clarification was needed to continue the processing of your application. You have 30 days from the date of the deficiency notice to submit the requested information or your application will be considered abandoned and removed.
- What if my entire application was returned to me?
- This means that your application did not meet ALBOP requirements for review. A letter of return will be enclosed and outline what requirements prevented the application from being accepted for review.
Renewals:
- When do I renew my facility permit?
- All facility permits expire on 12/31 of each year. The renewal must be submitted to our office before the expiration date.
- How do I submit a renewal for my facility permit?
- All renewals must be submitted online either via our homepage or the Facilities tab.
- When can I submit my renewal?
- The online renewal portal opens each year in early September. We recommend submitting your renewal as early as possible to allow for processing and to prevent any potential interruptions in your daily operations.
- How long does it take for my renewal to be processed?
- Renewals are reviewed within 7-10 business days from date of online submission. Once the renewal is approved, the expiration date will be updated and an email notification will be sent to the Business email address on file with printing instructions.
- What happens if my renewal was incomplete or there was a problem?
- A deficiency notice will be sent by email to the renewal contact person that was provided during the renewal process. The deficiency notice will list all concerns/issues and instructions for submission. All deficiencies must be submitted to our office within 30 days of the notice date listed on the form.
- I returned my deficiency notice and all needed information. When will my renewal be approved?
- Returned renewal deficiencies are processed in 7-10 business days from date of receipt in our office. If you would like to have a record of delivery, please use a carrier that offers tracking.
- How can I tell if my renewal has been approved?
- You can use the online verification option to see if the expiration date of your permit has been updated.
- To access the online verification, go to our home page and click Search for a License. Then select Business Lookup and enter the requested details. Once you find your facilities permit click the print icon to view the full permit details.
- You can use the online verification option to see if the expiration date of your permit has been updated.
- We did not complete our renewal by the expiration date and now our permit is Inactive.
- From January 1st -31st, you can still complete your renewal through the online portal on our website. Please note that late fees are applied and that there could be possible disciplinary action.
- Starting February 1st, the online portal is closed and you must request a late renewal packet by emailing sgamble@albop.com.
Change of Ownership Applications:
- How long do we have to report our change of ownership?
- The change of ownership application must be received in our office within 10 days of the effective date of the change of ownership.
- Can I submit the change of ownership before the effective date of the change of ownership?
- No, you must provide the required items on the application or your application will be returned as incomplete.
- What if I do not have all the items on the checklist at the time of submission?
- You must have the 3 required items listed on the checklist provided with the application at the time of submission. If you are not able to provide the remaining items at the time of submission, a change of ownership completion form will be sent to the application contact person provided with the application.
- What does it mean if I receive a change of ownership completion form?
- This form is sent to the application contact person to inform them of the documents that are outstanding for the completion of the change of ownership application. The applicant has 60 days from the date of notice to submit all needed documents per the instructions on the notice.
- Will I receive a notice that my application is being processed?
- If you wold like to know what day your application is received in our office, we recommend sending it using a carrier that offers an option for tracking.
- How long does it take to process a change of ownership application?
- The application will be processed in 7-10 business days from receipt in our office. If your application is not complete the change of ownership completion form will be sent to the application contact person. Once all documents are received and processed a notice of completion will be sent to the application contact person.
- Will I receive a new permit?
- New permit is not issued unless there is a change to the name or address of the applicant facility.
Designated Representative
- The email address on my permit is not correct. How do I correct this information?
- The contact email for all Facilities is the email address provided for the facility Designated Representative. If you would like to update this information, you must complete and submit an “Update CURRENT Designated Representative Form”
- How do I know what email address is listed for my facility?
- To access current information that we have on file for your facility, go to our home page and click “Search for a License”, then select Business Lookup and enter the requested details. Once you find your facilities permit, click the print icon to view the full permit details.