New Guidelines For Electronic Drug Product Reporting For Human Drug Compounding Outsourcing Facilities

The US Food and Drug Administration FDA announced guidelines for Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities.

The new guidelines will assist facilities that elect to register with FDA, as outsourcing facilities are directed to submit drug product reports.

They will carry out this process in adherence to section 503B of the Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b).

Section 503B of the FD&C Act provides that any facility that chooses to register with FDA as an outsourcing facility must provide FDA particular information about the drugs compounded at that outsourcing facility in the way that FDA may “prescribe by regulation or guidance.”

These guidelines define who must report and what information they must provide. It also elaborates that drug compounding reports must be submitted in Structured Product Labelling (SPL) format using FDA’s electronic submissions system.

This will make it a standardized form for submission, thus minimizing discrepancies.

These guidelines are an evolution to President Obama’s signing of a legislation called Drug Quality and Security Act (DQSA) in 2013.

This legislation enabled the compounding (manufacturing) of human drugs, drugs which are made to be used in humans, to be perused.

It was the DQSA that added the new section 503B to the FD&C Act, which allows any manufacturer to become an outsourcing facility by registering with FDA and meeting some other necessary requirements described in section 503B of the FD&C Act.

Once registered, the “outsourcing” status will exempt them from FDA approval requirements as well as from labelling the product, which won’t be a requirement anymore.

Despite the convenience, these guidelines are not exempted from standard checks.  Outsourcing facilities are inspected by FDA on the basis of risk-based schedule and must be in compliance with other provisions of the FD&C Act, such as current good manufacturing practice (CGMP) requirements.

Moreover, a facility that nominates itself to transform itself to be an outsourcing facility must, at the time of initial registration and twice annually, in the month of June and December, submit to FDA a report identifying the drugs being manufactured by the facility during the last 6 months.

The drug report, that an outsourcing facility must submit at initial registration and twice each year, under section 503B to FDA, should be carried out even if the facility has not manufactured any drug products during the last six months.

In this case, the facility must mention in their report that it has not manufactured any drug products during the period.

This report must identify all sterile and non-sterile drugs produced at the outsourcing facility during the last six months’ timeframe and provide all of the following information for each compounded drug:

  • The source of the active ingredient
  • The National Drug Code (NDC) number of the source drug or bulk active ingredient, if it is available
  • The dosage form and route of administration.
  • The active ingredient and strength of active ingredient per unit
  • The package description
  • The number of individual units produced
  • The NDC number of the final product, if assigned

For purposes of drug product reporting under section 503B(b), the strength of the active ingredient per unit means that it is the strength of the active ingredient per dose of the product.

Whereas the NDC number for both the source drug or bulk active ingredient and any fully completed drug product to which an NDC has been assigned must be submitted in the standard format of ten numerical digits, while the three segments will be separated by dashes, for example, in a 6-2-2, 5-3-2, or 6-3-1 configuration.

The package information is a little easier to grasp. The package description refers to the description of the smallest individual saleable package of the product for distribution and must include the type of package, for example if it’s a vial, syringe, or a bottle and the volume per package each package contains, for example, a 200 ml vial, 50 ml syringe, and 20 tablets per bottle.

The number of individual units produced means the number of the smallest individual saleable packages of drug produced for distribution.

As an example, if a registered outsourcing facility produces one thousand 100 ml vials of 5 mg/ml of Drug A, so keeping all above things in mind, the strength of the active ingredient per unit will be “5 mg/ml,” the package description will be “100 ml vials,” and the number of individual units manufactured is “1,000 vials.”

Similarly, if a registered outsourcing facility compounds 5 mg tablets of Drug Y in one thousand bottles of 100 tablets each, the strength of the active ingredient per unit is “5 mg,” the package description is “bottles of 100 tablets,” and the number of individual units produced is “1,000 bottles.”

Another example is if a registered outsourcing facility produces 10 mg tablets of Drug B in five thousand bottles of 200 tablets each, the strength of the active ingredient per unit is “10 mg,” the package description will be “bottles of 200 tablets,” and the amount of individual units produced will be “5,000 bottles.”

Therefore, these guidelines will allow the process of manufacturing drugs to be more streamlined, minimizing delays while still maintaining a level of safety and quality.

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