Apply
Important: Any new facility permit issued before December 31 must be renewed during that same calendar year, regardless of when the permit became active.
Facility permits are specific to the work performed at the permitted location. Review the definitions below and select the permit type that matches the facility’s actual operations.
How to Apply
- Create or use a personal Gateway profile. Do not create the profile in the facility’s name.
- In the Gateway, open Applications and select the appropriate facility application.
- Submit payment within seven days of starting the application or the application will expire.
- Provide every required checklist document. Incomplete submissions cause significant delays and may be withdrawn.
- After approval, return to the Gateway and print the facility permit.
Choose the Correct Permit Type
A facility, other than a pharmacy, that prepares, derives, produces, compounds, or packages a drug, medicine, chemical, or poison.
A facility engaged in distributing drugs, including medical oxygen, for resale to pharmacies, hospitals, practitioners, government agencies, or other lawful outlets permitted to sell drugs.
A facility that purchases or acquires a drug, chemical, or poison from a manufacturer or distributor for bottling, labeling, or other repackaging for sale or distribution.
An entity that provides or coordinates warehousing or other logistics services for a product in interstate commerce on behalf of a manufacturer or wholesale distributor, without taking ownership of the product or directing its sale or disposition.
A firm that does not manufacture or process a drug but markets and distributes under its own trade name a drug product made by another entity. The private label distributor is responsible for the products it introduces into interstate commerce and for compliance with applicable federal requirements and Current Good Manufacturing Practices.
Select this permit type when the facility’s operations involve manufacturing or wholesaling medical oxygen.
A chemical substance designated by the Alabama State Board of Pharmacy that has legitimate uses but may also be used in the unlawful manufacture of controlled substances.
Required for a person or entity that sells or provides medical oxygen directly or indirectly to patients or consumers and bills the patient, insurer, Medicare, Medicaid, or another third-party payer.
A facility at one geographic location that compounds sterile drugs, has elected to register with the FDA as an outsourcing facility, and meets the requirements of Section 503B(d)(4)(A) of the federal Food, Drug, and Cosmetic Act.
Facility & Designated Representative Fees
All application, renewal, and change-of-ownership fees are non-refundable. Please review the permit type definitions above before submitting payment.
Standard Facility Permits
Applies to manufacturers, wholesalers, repackagers, private label distributors, 503B outsourcing facilities, third-party logistics providers, reverse distributors, and applicable virtual or distribution-only permit types.
| Fee | Amount |
|---|---|
| Initial facility permit | $750 |
| Annual renewal | $500 |
| Change of ownership | $750 |
| Late renewal fee | $100 per month |
Controlled Substance Permits
Available only to facility types legally eligible to hold a controlled substance permit. Precursors, Virtual Entities, and Oxygen Wholesalers/Distributors are not eligible to apply for controlled substance permits.
| Fee | Amount |
|---|---|
| Initial controlled substance permit | $600 |
| Annual controlled substance permit renewal | $600 |
Retail Medical Oxygen Permits
| Fee | Amount |
|---|---|
| Initial permit | $400 |
| Renewal | $250 |
| Change of ownership | $750 |
| Late renewal fee | $100 per month |
Precursor Permits
Precursor permits renew every two years and are not eligible for a controlled substance permit.
| Fee | Amount |
|---|---|
| Initial precursor permit | $500 |
| Biennial renewal | $500 |
| Permit to possess a listed precursor chemical | $35 per occurrence |
| Change of ownership | $750 |
| Late renewal fee | $10 per month |
Designated Representative Registrations
| Fee | Amount |
|---|---|
| Initial registration | $100 |
| Background check — initial applications and reinstatements only | $40 |
| Annual renewal | $100 |
| Late renewal fee | $50 per month, up to $1,000 |
Administrative Fines
Separate administrative fines may apply for operating with an expired permit, failing to timely report a change of ownership or designated representative, or failing to maintain required records. Fine amounts vary based on the violation, length of delay prior occurrences, etc. See Alabama Administrative Code 680-X-2-.40 for details.
Documents Required to Apply
Review the requirements before paying. The exact checklist depends on the permit type and the facility’s operations. Additional information may be requested during review and will be identified in the Gateway.
NOTE – ALL REQUIRED DOCUMENTS MUST BE UPLOADED WITHIN 30 DAYS OF APPLICATION SUBMISSION.
Required for All Facility Types
- Copy of the home-state license
- Ownership organizational chart
- List of all states where the facility is licensed
- Proof of FDA reporting, except for precursor chemical permits
- Description of services
- DEA certificate, if applicable
- Proof of entity registration with the Alabama Secretary of State
Additional Documents by Permit Type
- Most recent FDA inspection, unredacted
- Response to the FDA inspection, unredacted
- Home-state inspection, if available
- Name, address, and Alabama permit number for each manufacturer distributed for. An Alabama permit number is required only for U.S. locations.
- List of drugs distributed under the labeler code
- NDA approval
- CMO contracts
- Facility photographs
- List of contract manufacturers
- Home-state inspection, if available
- List of drugs distributed under the labeler code
- NDA approval
- CMO contracts
- 3PL contracts
- Facility photographs
- Contract manufacturers
- Third-party logistics providers
- Home-state inspection, if available
- Entities for which the facility provides 3PL services, including name, address, and Alabama permit number
- Home-state inspection, if available
- Home-state inspection. If unavailable, provide proof of exemption.
- Home-state inspection, if available
- Wholesale trading partners, including name, address, and Alabama permit number
- List of all precursor chemicals
- Home-state inspection, if available
- In-state facilities only: Fire letter dated within the last 30 days
- FDA inspection, unredacted, if applicable
- Response to the FDA inspection, unredacted, if applicable
- If repackaging on behalf of other entities, a list of those entities
- List of compounds
- Beyond-use date policy
- NIOSH chemicals
- Compound testing policy
- Environmental tests or certifications
- Most recent FDA inspection, unredacted
- Response to the FDA inspection, unredacted
- Discipline, recalls, and seizures
- Labeled floor plan
- Facility photographs
Designated Representatives
New Designated Representative Registration
New designated representatives must complete an application and background check to receive a registration number. Review Alabama Administrative Code 680-X-2-.23 for the requirements.
- Create or use a personal Gateway profile.
- Open Applications and select New Designated Representative.
- Submit payment within seven days and provide all required documentation.
- After approval, the DR registration number will appear on the green Gateway tile. Designated representatives do not receive a separate paper permit.
DR Renewal
- The renewal fee is $100.
- Routine uploads are not required. If a discipline question is answered Yes or the Board requests documentation, upload the requested information.
- The renewed registration is issued for one year.
Updates and Facility Changes
Use the Update Current Designated Representative Information Form only to update information for an individual who already has a DR registration number. Do not use it to replace a facility’s DR.
To change a facility’s designated representative, follow the DR Helpful Tips.
Gateway Help and Permit Management
Gateway profiles belong to individuals, not facilities. After creating a personal profile, an authorized user can be connected to the facility permit.
Gateway Tutorials
Tasks Available in the Gateway
- View the facility permit and application status
- Print the facility permit
- Manage employee information
- Pay an assessed fee or fine
Changes Requiring a Filing
- Use a Facility Amendment for changes to the facility name, address, or phone number.
- Use Manage Owners and the Change of Ownership application for ownership changes.
- Follow the DR Helpful Tips to replace a facility’s designated representative.
Gateway Access for Authorized Representatives
Licensing companies and other authorized representatives who do not hold an individual ALBOP license or registration should create a personal Gateway profile in their own name. Do not create a profile in the facility’s name. After creating the profile, email tking@albop.com to request access to the facility permit.
Change of Ownership
A change of ownership application must be submitted after the transaction closes. The application will not be accepted before closing.
Deadlines
- Begin the filing through Manage Owners on the green facility tile.
- Submit the application fee and Change of Ownership Application and Affirmation within 10 days after closing.
- Payment must be completed within seven days after starting the online application or the application will expire.
- Submit all remaining checklist documents within 60 days of the initial application.
Processing generally takes 10–15 business days after all required information is received. A new permit number is not issued. If the facility name or address changes, print the updated permit from the Gateway after completion.
Renew
Renewal Schedule
- Renewals open October 1.
- Most facility permits renew annually. Precursor permits renew every two years.
- The renewal deadline is December 31 of the applicable renewal year.
- Apply early to allow time to correct any deficiencies.
If the permit has expired, review Reinstatement and Late Renewal below. Gateway setup and video tutorials are available under Gateway Help and Permit Management.
Reinstatement and Late Renewal
- January 1–31: Submit a late renewal through the Gateway. Late fees and possible discipline may apply.
- February 1 and after: The renewal portal is closed. Open the expired facility tile and submit a reinstatement application.
Submit all requested information promptly. Applications requiring staff review generally take 10–15 business days after all required information is received.
Facility FAQs
Before You Apply
Review all facility definitions before applying:
- The permit definitions under Apply on this page
- Alabama Administrative Code 680-X-2-.23
- Types of Drug Facility Permits within the online application
Select the permit type that matches the facility’s actual operations.
No. Review the checklist before paying and do not submit an incomplete application. Application fees are non-refundable.
If you are unsure whether a document applies to your facility, contact tking@albop.com before paying.
Apply only after the products have received FDA approval, all required FDA reporting is complete, and every other application requirement is in place.
The Board will not approve the distribution of unapproved products or hold an incomplete application while approvals or documents are pending.
Your selections may indicate that the application does not meet Alabama requirements. Select Save Application & Exit and follow the instructions in the pop-up before submitting payment.
New Facility Applications
The average processing time is approximately 90 business days. Processing time varies by application and may increase during renewal season, October 1 through January 31.
No courtesy acceptance email is sent.
After payment and receipt of all required documents, the application enters the review queue. An initial queue review generally occurs within 10–15 business days, in the order received.
The Board needs additional documentation or clarification. Submit everything requested within 30 days of the notice. Failure to respond may result in the application being closed. Application fees are non-refundable.
Change of Ownership
Submit the application within 10 days after the ownership change closes. In the Gateway, open the facility tile and select Manage Owners under Permit Options.
No. The application will not be accepted before the ownership change closes.
Within 10 days after closing, submit:
- Application fee
- Change of Ownership Application and Affirmation
Submit all remaining checklist documents within 60 days of the initial application.
The application may be withdrawn if the Change of Ownership Application and Affirmation is not received within 10 days, or if the remaining checklist documents are not received within 60 days. Application fees are non-refundable.
Processing generally takes 10–15 business days after all required information is received.
No new permit number is issued. If the facility’s name or address changes, print an updated permit from the Gateway after the change is completed.
Facility Renewals
Most facility permits renew annually. Precursor permits renew every two years. Facility permits expire December 31 of their applicable renewal year.
Facility renewals open October 1 and must be submitted through the Gateway by December 31. Apply early to allow time to correct any deficiencies.
Renewals requiring manual review generally take 10–15 business days. Responding to a deficiency may require an additional 10–15 business days.
The Board will issue an Application Action Needed notice. Submit all requested information within 30 days of the notice.
Check the permit status in the Gateway. Routine status emails are not provided during renewal season.
From January 1 through January 31, submit a late renewal through the Gateway. Late fees and possible discipline may apply. On February 1, the renewal portal closes; submit a reinstatement application from the expired facility tile.