Registered Outsourcing Facilities
Firms Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Updated as of 2/28/14
Date of Registration as an Outsourcing Facility1
End Date of Last FDA Inspection Related to Compounding2
Was a Form FDA-483 issued?3
Compounds Sterile Drugs From Bulk Drug Substances6
Advanced Pharma, Inc., Houston, TX
Allergy Laboratories, Inc., Oklahoma City, OK
|12/30/2013||4/26/2013||Yes||Warning Letter - 9/4/2013||Yes|
|Avella of Deer Valley, Phoenix, AZ||2/24/2014||2/25/2013||Yes||Warning Letter - 1/17/2014||No|
|Banner Health, Chandler, AZ||12/26/2013||Not yet inspected||N/A||N/A||No|
|Cantrell Drug Company, Litte Rock, AR||12/16/2013||11/4/2013||Yes||Open||Yes|
|Central Admixture Pharmacy Services, Inc., Allentown, PA||2/28/2014||Not yet inspected||N/A||N/A||Yes|
|Edge Pharmacy Services LLC, Colchester, VT||1/21/2014||Not yet inspected||N/A||N/A||Yes|
|Greer Laboratories, Inc., Lenoir, NC||2/24/2014||11/15/2013||Yes||Open||Yes|
Healix Infusion Therapy, Inc., Sugar Land, TX
|2/12/2014||Not yet inspected||N/A||N/A||Yes|
|Infusion Options INC., Brooklyn, NY||1/24/2014||Not yet inspected||N/A||N/A||No|
JCB Laboratories, North Wichita, KS
|Kings Park Slope, Inc., Brooklyn, NY||12/23/2013||Not yet inspected||N/A||N/A||Yes|
|KRS Global Biotechnology, Inc., Boca Raton, FL||12/15/2013||Not yet inspected||N/A||N/A||Yes|
|Leiter's Compounding, (Great Oaks Blvd), San Jose, CA||1/31/2014||Not yet inspected||N/A||N/A||Yes|
|Marlborough Hospital, Marlborough, MA||12/26/2013||Not yet inspected||N/A||N/A||Yes|
Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC
Pharmagen Laboratories Inc., Stamford, CT
|Pharmakon Pharmaceuticals, Noblesville, IN||1/23/2014||Not yet inspected||N/A||N/A||No|
PharMedium Services, LLC, Cleveland, MS
PharMedium Services, LLC, Edison, NJ
PharMedium Services, LLC, Memphis, TN
PharMedium Services, LLC, Sugar Land, TX
|RC Compounding Services LLC, Poland, OH||2/12/2014||2/7/2013||Yes||Open||Yes|
|Region Care, Inc., Great Neck, NY||12/24/2013||Not yet inspected||N/A||N/A||Yes|
SCA Pharmaceuticals, Little Rock, AR
Not yet inspected
|SSM St. Clare Health Center, Fenton, MO||2/18/2014||Not yet inspected||N/A||N/A||No|
Triangle Compounding Pharmacy Inc., Cary, NC
|1/24/2014||3/1/2013||Yes||Warning Letter - 1/14/2014||Yes|
|Unique Pharmaceuticals, Ltd., Temple TX||1/24/2014||5/19/2004||No||No||Yes|
|US Compounding, Inc., Conway, AR||12/20/2013||Not yet inspected||N/A||N/A||Yes|
US Specialty Formulations LLC, Bethlehem, PA
|1/31/2014||Not yet inspected||N/A||N/A||Yes|
1. The date of registration is the date upon which the required registration information has been determined by FDA to be complete. This table will be updated weekly and will list outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table.
2. Inspections and other history referenced in this table are associated with the specific registered outsourcing facility at the listed address. A registered outsourcing facility may be owned or operated by a company that also owns or operates other compounding facilities. FDA’s web page on Compounding: Inspections, Recalls, and Other Actions may contain information about other related compounding facilities which may be under the same ownership as the listed registered outsourcing facility.
In addition, please note that inspections may take place over several days, weeks, or longer. The date of the inspection is the date a Form FDA-483 listing the investigators observations is issued or, if no FDA Form-483 is issued, the last day of the inspection.
3. An FDA Form 483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of our relevant regulations.
4. This table includes only FDA actions. It does not include actions, if any, by a State Board of Pharmacy. To determine whether a registered outsourcing facility has been the subject of a State enforcement action, check with the State Board of Pharmacy for the state in which the facility is located. Some states post disciplinary or other actions on their web sites. For more information, please see Compounding: Inspections, Recalls, and other Actions.
5. If the inspection has been closed without further action, the word “closed” will appear. If the inspection has not been closed, the word “open” will appear. Open does not mean that FDA has determined that further action will be taken. It means only that a determination has not yet been made. If an action has been taken, it will be listed. Possible FDA actions may include: warning letter; seizure; or injunction.
6. This column is based on information provided by the registered outsourcing facility at the time of registration and has not been verified by FDA. If this column says “N/A”, it is because the registered outsourcing facility has not provided this information. In the future, FDA intends to provide information about whether the outsourcing facility also intends to compound nonsterile drugs from bulk drug substances, but this information is not currently available to the Agency.
- How does registration as a human drug compounding outsourcing facility under section 503B work?
- What happens after a facility first registers with FDA as an outsourcing facility under section 503B?
- What does it mean to be registered as a human drug compounding outsourcing facility under section 503B?
- If FDA has inspected a human drug compounding outsourcing facility, can I be sure that the drugs I purchase from that facility are safe?
- If I purchase drugs from a company that has multiple facilities, how can I be sure about the quality of the specific compounded drugs I purchase?
- What does an outsourcing facility do?
- Is it safe for me to purchase drugs in shortage from a registered outsourcing facility?
To register as an outsourcing facility, a compounder must send an email or use the electronic registration system to provide the following information: name; place of business; unique facility identifier; point of contact email address; an indication of whether the facility intends to compound products on FDA’s drug shortage list; an indication of whether the facility compounds from bulk drug substances, and if so, whether it compounds sterile drugs from bulk drug substances.
When FDA receives a submission for registration, FDA will review the submission to determine whether the required information has been provided, and if so, the outsourcing facility will be considered registered. If the information is not complete, FDA will contact the registrant and ask that they provide the necessary information. A firm will not be considered registered until the information is complete.
Beginning October 1, 2014, outsourcing facilities will be required to pay a fee at the time of registration. The amount of this fee and directions for paying the fee will be published in the Federal Register in early August 2014. Facilities for which the proper fee has not been received on or after October 1, 2014 will not be considered to be registered and will be removed from this list of registered outsourcing facilities.
2. What happens after a facility first registers with FDA as an outsourcing facility under section 503B?
Once an outsourcing facility is registered, the facility is subject to inspection by FDA and will be added to the list of facilities FDA intends to inspect. Outsourcing facilities are to be inspected according to a risk-based schedule. Depending on the number of outsourcing facility registrants and other inspection priorities, FDA expects to inspect newly registered outsourcing facilities within two months of initial registration, if the facility has not been previously inspected. Subsequent inspections will depend on the findings from the first inspection and other factors including but not limited to: the compliance history of the outsourcing facility; the record, history, and nature of recalls linked to the outsourcing facility; the inherent risk of the drugs compounded at the outsourcing facility; the inspection frequency and history of the outsourcing facility, including whether the outsourcing facility has been inspected within the last 4 years; and whether the outsourcing facility has registered as an entity that intends to compound drugs in shortage.
3. What does it mean to be registered as a human drug compounding outsourcing facility under section 503B?
Registration means only that FDA has received the information required to register the facility. It does not mean that the facility is making FDA-approved drugs and it does not mean it is in compliance with current good manufacturing practice requirements, the other conditions of section 503B, or other requirements in the Act. Approval of a drug requires the submission and approval of a new drug application or an abbreviated new drug application. Facilities registered as human drug compounding outsourcing facilities are required to comply with current good manufacturing practice requirements; report adverse events to FDA; label their products with certain information; and meet certain other requirements if they are to qualify for the exemptions from the new drug approval and adequate directions for use requirements of the Act. Outsourcing facilities that comply with the conditions for exemption under section 503B are not required to obtain new drug approvals. Listing of an outsourcing facility on this list does not mean that FDA has determined that the outsourcing facility is in compliance with these requirements or that it has met the conditions to qualify the exemptions under section 503B.
4. If FDA has inspected a human drug compounding outsourcing facility, can I be sure that the drugs I purchase from that facility are safe?
Drugs made by compounders, including those made at human drug compounding outsourcing facilities, are NOT FDA-approved. This means that they have not undergone the same premarket review as approved drugs. They lack an FDA review of safety and efficacy and of manufacturing quality. Therefore, when an FDA-approved drug is commercially available, FDA recommends that practitioners prescribe the FDA-approved drug rather than a compounded drug unless the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product.
Although the drugs will not be FDA approved, purchasers of drugs compounded at a registered outsourcing facility that has had a recent satisfactory FDA inspection will have some assurance that the conditions at that facility met applicable current good manufacturing practice standards at the time of the inspection, and the compounded drugs are labeled with the required information. It should be noted, however, that FDA inspections are just a snapshot in time. Conditions at the facility can change at any time. And FDA only reviews a small sample of the records available at a facility during an inspection and must draw conclusions about the conditions and practices at the facility from that small sample of records. Purchasers should look at other available information about the facility that can provide them with additional insight with regard to the facility’s operations.
5. If I purchase drugs from a company that has multiple facilities, how can I be sure about the quality of the specific compounded drugs I purchase?
Registration and inspections are facility specific and do not apply to all facilities under common ownership and control. Before purchasing drugs from a corporate entity, you should determine that the specific facility in which the drugs are compounded is a registered outsourcing facility with a satisfactory inspection.
Under section 503B, outsourcing facilities that compound human drugs may register and meet certain other requirements to qualify for the exemptions from the new drug approval requirements and the requirements for adequate directions for use. Under section 503B, an outsourcing facility is a facility that:
- Is engaged in the compounding of sterile drugs
- Has elected to register as an outsourcing facility
- Complies with all of the requirements of section 503B
- Is not required to be a licensed pharmacy, but compounding must be by or under the direct supervision of a licensed pharmacist
- May or may not obtain prescriptions for identified individual patients
When registering, an outsourcing facility must pay a fee. Registering as an outsourcer means that the compounding pharmacy will be inspected according to a risk-based schedule.
Drugs compounded in registered outsourcing facilities that have had a satisfactory FDA inspection may have more assurance of safety than those made by other non-registered compounders because they are to be made in accordance with current good manufacturing practice standards. However, drugs made by compounders, including those made at human drug compounding outsourcing facilities, are NOT FDA-approved. This means that they have not undergone the same premarket review as approved drugs. They lack an FDA review of safety and efficacy and of manufacturing quality. Therefore, when an FDA-approved drug is commercially available, or an alternative FDA-approved drug can be used, the FDA recommends that practitioners prescribe the FDA-approved drug rather than a compounded drug unless the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product.
For drugs compounded by registered outsourcing facilities that are on the FDA Drug Shortage List, the drug must be compounded after the drug is placed on the drug shortage list and may not be dispensed or administered to a patient after it has been removed from the drug shortage list. Therefore, compounders may place shorter beyond use or expiration dates on such products to ensure that they will be used within this period and compounders and purchasers will not be left with inventory of drugs that cannot be used because they are no longer in shortage.