Compounding Information Concerning Outsourcing Facility Registration
Information Concerning Outsourcing Facility Registration
- 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
List1, 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.
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