Registered Human Drug Compounding Outsourcing Facilities with the FDA: Where the Count Stands as of Today and A Summary of those Registered as Outsourcing Facilities

April 17, 2014
by Sue Tuck Richmond
 
The United States Food and Drug Administration (FDA) has clearly been busy since the enactment of the Drug Quality and Security Act of 2013 (DQSA), which contains the Compounding Quality Act.  Section 503B of the DQSA created a new category of compounding pharmacies--Outsourcing Facilities.  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

 
To be classified as an Outsourcing Facility under 503B, a compounder that compounds human drugs must register with the FDA and pay a fee.  Registering with the FDA  is voluntary.  For those compounders who register and meet certain other requirements, they are exempt from the new drug approval requirements and the requirements for adequate directions for use. Registering also means the Outsourcing Facility will be inspected by the FDA.  The frequency of an FDA inspection depends on a number of factors.  Regarding inspections of Registered Outsourcing Facilities, the FDA has stated on its website that: 

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.

quoted from FDA/Drugs/Guidance, Compliance, Regulatory Information/Compounding/Information Concerning Outsourcing Facility Registration


The FDA appears to be very transparent about Outsourcing Facilities that are registering.  Its website contains a chart detailing the following information:

1.  Date of Registration as an Outsourcing Facility
2.  End Date of Last FDA Inspection Related to Compounding
3.  Was A Form FDA 483 Issued
4.  Other FDA Action, if Any, Based on Last Inspection
5.  Compound Sterile Drugs From Bulk Drug Substances
 

The chart with this information is found here. 

To date the FDA has registered 38 Outsourcing Facilities. Others may have registered with the FDA as an Outsourcing Facility, however, until the FDA receives all the necessary information and determines the information is complete the name of the compounder will not appear on the FDA's website of registered Outsourcing Facilities.

Of the 38 Outsourcing Facilities whose registration the FDA has deemed complete, the FDA has already inspected 17 of those--or not quite half of those registered-- but still an astonishing amount of inspections in a short amount of time.  All but one of the inspections--that for Unique  Pharmaceuticals, Ltd., Temple, TX  which was done in 2004--have been completed in 2013 and 2014.  I feel certain the FDA is also in the process of completing inspections for the remaining 21 registered Outsourcing Facilities as quickly as they can, and the FDA will post  this information as it becomes available.

Of the 38 registered, 20 have received a FDA 483s. The FDA issues a Form 483 when investigators observe any significant, objectionable conditions.  The issuance of a Form 483 does not, however, constitute a final FDA determination of whether any condition is a violation of the law or any relevant regulations. To date, FDA Warning Letters have been issued to five Outsourcing Facilities  on the list-- 

1.  Allergy Laboratories, Inc., Oklahoma City, OK;  Inc., Oklahoma City, OK
2.  Avella of Deer Valley, Phoenix, AZ
3. Lowlite Investments, Inc. dba Olympia Pharmacy, Orlando, FL
4.  Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC
5.  Triangle Compounding Pharmacy Inc., Cary, NC

Fifteen of the Outsourcing Facilities inspections have not been closed by the FDA which is indicated by the word "open" in the column of the chart entitled Other FDA Action, if Any, Based on Last Inspection. This means only that the FDA has not made a determination about future action; it does not mean the FDA has determined that further action such a warning letter, seizure or injunction will in fact be taken.    If the inspection has been closed without further action, the word “closed” will appear.   None of the Outsourcing Facilities show the word "closed" at this time.  Only one Outsourcing Facility indicates that no action was taken as a result of the inspection, and that is for Unique Pharmaceuticals, Ltd., Temple, TX who last noted inspection was in 2004. 

Also worth noting is that the table on the FDA website includes only FDA actions. It does not include actions that State Board of Pharmacy may have taken.   In footnote 4 of the chart, the FDA reminds readers to check with States Boards of Pharmacies to determine whether a registered outsourcing facility has been the subject of a State enforcement action  The FDA also points out a significant problem in that only  some states post disciplinary or other actions on their web sites.

In footnote six to the chart the FDA explains the information under the" Compound Sterile Drugs From Bulk Drug Substances"  heading.   The FDA notes that this information has not been verified and is based on information provided by the registered outsourcing facility when it registered.  If the column shows "N/A,"  it is because the outsourcing facility failed to provide this information when it registered.
The FDA indicates also in footnote six that it " 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."


Stay tuned.  The FDA will continue to update and provide information regarding registered Outsourcing Facilities, inspections, and action taken and more compounders will likely register in the future, especially once the FDA finalizes more guidance relating to Registered Outsourcing Facilities such as

Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act Concerning Outsourcing Facilities; Request for Nominations⁶

Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations