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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

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

New Manufacturer Application

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. 

New Wholesale Distributor Application

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. 

New Repackager Application

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. 

New 3PL Application

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. 

New Private Label Distributor Application

OXYGEN MANUFACTURER/WHOLESALER

New Oxygen Manufacturer/Wholesaler Application

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. 

New Precursor Application

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.

New Application

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. 

New 503B Application

Designated Representative Registration

New information for Designated Representatives

Effective January 14, 2024, all designated representatives are required to complete a background check and application to receive a registration number. The application will allow the designated representative to link themselves to their current facility. All facilities are required to complete this registration no later than March 15th, 2024. See Alabama administrative code 680-X-2-.23 for all requirements.

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.

Print Permit

Click here to print your facility permit

Frequently Asked Questions

Designated Representatives:

New Applications:

  1. How long does the new application process take?
    • The average processing time for new applications is 90 business days.
  2. 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 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 could be affected during renewal season October 1-January 31 of each year). 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.
  3. 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.
  4. 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:

  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 portal that can be found on our home page.
  3. When can I submit my renewal?
    • The online renewal portal opens each year in September/October. Check our website frequently to ensure that you are aware the portal is open. 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 typically reviewed within 10-15 business days from the 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.
  5. 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.
    • Renewal deficiency notices have very specific instructions for how to submit a response and email submission is not acceptable. Per the instructions, all needed items are to be submitted by common carrier to the provided address with the renewal deficiency as a cover sheet. We are processing thousands of renewals at a time and are not able to keep track of multiple emails and different submissions. We highly recommend that you submit your information per the instructions on the notice so that your deficiency can be properly processed.
  6. I returned my deficiency notice and all needed information. When will my renewal be approved?
    • Returned renewal deficiencies are generally processed in 10-15 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.
  7. 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.
  8. We did not complete our renewal by the expiration date and now our permit is Expired/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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. How long does it take to process a change of ownership application?
    • The application will be processed in 10-15 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.
  7. 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.