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.

To begin applying:

1. Using the link on the ALBOP homepage, create a Gateway profile if you have not already done so. Note this Gateway profile is a personal profile, not a profile for the pharmacy itself. For more instructions on how to do this, please view our “How to Create a New Gateway Profile” video tutorial.
2. Log in to your Gateway, click the Applications tab, and select the appropriate new application. You will have 7 days to submit payment or the application will expire.  Please be sure that you pay, and provide ALL required documentation to avoid extensive delays or withdrawals.
3. Once you receive your approval email, log back in to your Gateway profile to print your permit.

MANUFACTURER

Every facility, except a pharmacy, that prepares, derives, produces, compounds, or packages any drug, medicine, chemical or poison. 

WHOLESALE DRUG DISTRIBUTOR

Every facility engaged in the business of distributing drugs, to include medical oxygen, for resale to pharmacies, hospitals, practitioners, government agencies or other lawful outlets permitted to sell drugs. 

REPACKAGER

 facility that purchases or acquires from a manufacturer or distributor, a drug, chemical, or poison for the purpose of bottling, labeling, or otherwise repackaging for sale or distribution. 

THIRD PARTY LOGISTICS (3PL)

(Abbreviated as 3PL, or TPL) An entity that provides or coordinates warehousing or other logistics services of a product in interstate commerce on behalf of a manufacturer or wholesale distributor of a product that neither takes ownership of the product nor has responsibility to direct the sale or disposition of the product. 

PRIVATE LABEL DISTRIBUTOR

A firm that does not participate in the manufacturing or processing of a drug but instead markets and distributes under its own trade name and labels a drug product made by someone else. A private label distributor is responsible for the products it introduces into interstate commerce and for compliance with federal Food, Drug and Cosmetic Act requirements and Current Good Manufacturing Practices 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. 

To begin a new DR application:

1. Using the link on the ALBOP homepage, create a Gateway profile if you have not already done so. Note this Gateway profile is a personal profile, not a profile for the facility itself. For more instructions on how to do this, please click the “DR Helpful Tips” below.
2. Log in to your Gateway, click the Applications tab, and select “New Designated Representative” application.
3. You will have 7 days to submit payment or the application will expire.  Please be sure that you pay and provide ALL required documentation to avoid extensive delays or withdrawals.
4. Once you receive your approval email, you will see a green tile on your Gateway homepage that will include your DR registration number. Once approved, log back in to your Gateway profile to obtain your DR registration number. (**Please note that Designated Representatives do not have an actual permit. The DR Name and Number will reflect on a Facilities permit if you are an Active DR for a Facility.  If you are not a DR for a Facility, please use the “Search For A License” feature on our website homepage to obtain a verification for your records.)

• To change a facility’s DR, please see in the instructions by clicking the “DR Helpful Tips” below.
  
• Update CURRENT Designated Representative Information Form – This form is only used to update information (name, address, email address, etc.) for a DR who has been issued a DR registration number. DO NOT use this form to change a DR.
• DR Helpful Tips

Please log in to your Gateway for the reinstatement/late renewal process.

***Note: If you are a precursor, create a personal Gateway profile (not a profile for the permit), and email tlinville@albop.com who will grant you admin rights.***

Once logged in to your Gateway, you will be able to:

• Update contact info
• Update employees
• Change name and address
• Add/remove yourself as designated representative
• Print your permit
• Pay fee/fine

• Using the link on the ALBOP homepage, create a Gateway profile if you have not already done so. For more instructions on how to do this, please view our “How to Create a New Gateway Profile” video tutorial.
• Log in to your Gateway, click the green Facility tile, and select Manage Owners on the lefthand side. You will have 7 days to submit payment or the application will expire.  Please be sure that you pay, and provide ALL required documentation to avoid extensive delays or withdrawals.

New Applications:

1. How long does the new application process take?
   • The average processing time for new applications is 90 business days.  **This is a general time.  Each application is different, and processing time will vary per applicant.
2. Will I receive notice that my application is being processed?
   • No.  This office does not send courtesy emails regarding the acceptance of an application.  Once you pay for your application, and you have provided ALL the documents requested, your application is in the Queue for review. A cursory review of all applications will be completed in the order they are received. This process is generally 10-15 business days from the date of receipt (please note the processing time for all new applications will be significantly affected during renewal season October 1st  through January 31st of each year). If the application is complete, meaning EVERY document requested is uploaded, an initial review will take place. 
3. I received a notice via email labeled “Application Action Needed”, 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 notice to submit the requested information or your application will be considered abandoned and removed. **Please note that all applications are non-refundable.  If an application is withdrawn due to deficiencies not being met, no refunds will be issued**
4. I received a pop-up advising me to email someone to determine the next steps while I was completing my new application, why did this happen?
   • This means that your application may not meet ALBOP requirements for review, based on selections you have made to this point in your application.  Please proceed by sending the email as advised by our office to determine what is needed.  All application fees are non-refundable; therefore, we are trying to avoid applications being submitted and paid for if they are not needed. Please be sure to click the BLUE “Save Application & Exit” button when leaving the application to SAVE your progress up to this point.
5. I do not have all the required uploads, what should I do?
   • All items required are clearly outlined prior to paying for an application.  Please do not pay for an incomplete application.  If you are unable to provide every document requested, please stop the process and re-apply once you have all documents ready to apply entirely.  If you are unsure if the items requested apply to you, please contact tlinville@albop.com for clarification.
6. For a Private Label Distribution Applicant – Your facility should wait until you are within 6 weeks of the anticipated FDA approval of your products before submitting your application.  This Board will not approve the distribution of unapproved products.
7. I am not sure what application to select.  How do I determine which facility type to select?
   • There are sections available on our website to review for all Facility Definitions. 
     • All definitions are in the Statutes and Rules Section, specifically, Alabama Administrative Code 680-X-2-.23.
     • All definitions are also clearly listed in the facilities tab, under the heading “Apply”.
     • There is a page conveniently embedded in the initial Drug Facility Application labeled “Types of Drug Facility Permits” which will allow you to review the different options. 
   • Please be sure to review ALL the definitions prior to completing the application to ensure you are applying according to the definitions outlined.

Change of Ownership Applications:

1. How long do we have to report our change of ownership?
   • You must log in to the gateway, click the facility tile, and Under permit options on the left, choose “Manage Owners”.  You MUST pay the application fee, and submit the document provided in the list of items labeled “Change Ownership Application and Affirmation” within the 10 Days AFTER the close of the change. 
2. Can I submit the change of ownership before the effective date of the change of ownership?
   • No.  The change of ownership application must be submitted within 10 days after the change has occurred.  ***Do NOT submit a change of ownership prior to the change’s occurrence.  The application will NOT be accepted prior to the CLOSE of the change. **Please note that ALL application fees are non-refundable.
3. What if I do not have all the items on the checklist at the time of submission?
   • You MUST pay the application fee, and submit the document provided in the list of items labeled “Change Ownership Application and Affirmation” within the 10 days.   All other items requested must be submitted within 60 days of initial submission.
4. How long does it take to process a change of ownership application?
   • The application will be processed in 10-15 business days from receipt.  If we do not receive the Change of Ownership Application and Affirmation within 10 days, your application will be withdrawn. **Please note that ALL application fees are non-refundable.
   • If the remaining required items are not received within 60 days, your application will be withdrawn.  **Please note that ALL application fees are non-refundable.
5. Will I receive a new permit?
   • A new permit is not issued. 
   • If a name change occurs because of the change, you will need to print the new permit reflecting the updated information once the change of ownership is completed.
   • If a change of address occurs because of the change, you will need to print the new permit reflecting the updated information once the change of ownership is completed.

Renewals:

1. 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.
2. How do I submit a renewal for my facility permit?
   • All renewals must be submitted through the online gateway portal.
3. When can I submit my renewal?
   • The renewal portal opens each year on October 1st. We recommend submitting your renewal as early as possible to allow for processing and to prevent any potential interruptions in your daily operations.
4. How long does it take for my renewal to be processed?
   • Renewals are reviewed within 10-15 business days from the date of online submission. Once the renewal is reviewed, your gateway will reflect the progress.  
5. What would happen if my renewal was incomplete or there was a problem?
   • An “Application Action Needed” notice will be sent by email for each deficient item with instructions for what is needed. All deficiencies must be submitted to within 30 days of the date the notice was sent.
6. I provided all the necessary information. When will my renewal be approved?
   • Renewal deficiencies are processed in 10-15 business days from the date of submission.
7. How can I tell if my renewal has been approved?
   • We recommend logging into the Gateway often during the renewal process for updates.  All communication will take place in the Gateway.  NO EMAIL UPDATES WILL BE PROVIDED DURING THE RENEWAL SEASON.  Continuous emails significantly delay renewal reviews.
8. We did not complete our renewal by the expiration date (12/31) and now our permit is Inactive. What’s next?
   • From January 1st -31st you can still complete your renewal through the online portal. Please note that late fees are applied and that there could be possible disciplinary action.
   • Starting February 1st, the online renewal portal is closed, and you must complete a reinstatement, which is in the online gateway.  (Click on the expired facility tile, and search the left side bar for reinstatement options)

• Alabama Secretary of State website