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The California Department of Health Services' Food and Drug Branch (DHS) has
implemented changes to the Drug Manufacturing License process for Human
Prescription Drug Manufacturers.
BACKGROUND
In 1988, the federal Prescription Drug Marketing Act of 1987 (PDMA) (Pub. L.
100-293, 102 Stat 95), was enacted in response to serious public health and
safety problems, associated with the "diversion market" for
prescription drugs. Congress found that adulterated, mislabeled, subpotent,
expired, or counterfeit drugs were easily introduced into the national
distribution system due to the activities of a wholesale sub-market, commonly
known as the "diversion market," where drug products were accessible
from sources outside of normal channels of distribution.
In 1990, the US FDA published final federal regulations mandating state
guidelines for enforcing minimum requirements on prescription drug storage and
security, as well as on the treatment of returned, damaged, and outdated
prescription drugs. Further, wholesale drug distributors were required to
establish and maintain inventories and records of all transactions regarding the
receipt and distribution of prescription drugs and make these available for
inspection and copying by authorized law enforcement officials (21 CFR 205).
In 1992, California adopted emergency regulations in conformance to the PDMA,
which are currently found in the California Code of Regulations (17 CCR 10376,
10377, and 10377.1 thru 10377.8). All Human Prescription Drug
Manufacturers in CA were to comply with these regulations governing the
establishment of storage, handling, record keeping, security systems, etc., in
their operations. In addition, these regulations established a new drug
manufacturing application form and an additional $100 annual fee assessment to
support DHS' costs to inspect for compliance with PDMA, along with other
existing licensing requirements pursuant to the CA Health & Safety
Code. However, enforcement of these regulations was suspended due to a
lack of resources.
IMPLEMENTATION
Beginning July 1, 2005, DHS has increased the Drug Manufacturing License Fee
and has fully implemented the enforcement of the PDMA requirements pursuant to
the CA Code of Regulations mentioned above. The following information is
provided to assist in understanding the changes to the Licensing process.
First of all, the Drug Manufacturing License Applications (CDPH 52 N and
CDPH 52 R) has been
modified to capture additional information specifically required in the PDMA to
be evaluated by CDPH. General information about a facility's ownership and
type of manufacturing is still required by all applicants. But for those
companies involved in the manufacturing of Human Prescription Drugs, the
principle individuals identified as having direct responsibilities over the
manufacturing operations (Line #9 of the Application) and the owners, partners,
or the five highest-ranking corporate officers/directors/stockholders (Line #23
of the Application) must also be specifically identified. The Application
must be fully completed and submitted annually with the appropriate fee (plus
the $100 PDMA fee), to to address listed on the form. Incomplete
applications, and/or insufficient fees, will result in the return of an
unprocessed application packet back to the applicant.
Secondly, a confidential
Disclosure Statement (CDPH 53) must be submitted for
specific principle individuals representing the Human Prescription Drug
Manufacturer (HPDM). Those individuals identified in Lines #9 and #23 of the
License Application (EH 52) must provide information about any substance
addiction, professional licensing, and/or criminal background information on the
Disclosure Statement. Each individual must submit the statement to DHS for
evaluation, as a condition for licensing the specific drug manufacturing
facility for which he or she is associated with. Like the application, the
confidential Disclosure Statement must also be fully completed and submitted to
the corresponding DHS address on the form.
Lastly, in association with the Disclosure Statement (EH53), the individual
identified on Lines #9 and #23 of the License Application (EH 52) must also
submit to an Applicant Fingerprint Live Scan to verify any criminal history
disclosed. The Live Scan system is administered by independent operators
in your area who will forward electronic fingerprint scans directly to the CA
Department of Justice (DOJ) for the purpose of conducting criminal history
background reviews of the identified applicants. DOJ will then deliver their
results to DHS for use in making a final determination regarding a firm's
manufacturing licensing qualifications
Please note that separate fingerprint processing fees may be charged by both
the CA Department of Justice and the Live Scan operator who will collect them
accordingly. To find the Fingerprint Live Scan site nearest you and a
listing of fees, go to the CA Attorney General's website at: http://ag.ca.gov/fingerprints/publications/contact.htm
IN SUMMARY
For HPDMs, all of the items mentioned
above: 1) License Application (EH 52) with fees, 2) Disclosure Statement (EH
53), and 3) the Fingerprint Live Scans, must be completed and found satisfactory
in order for the Drug Manufacturing Licensing process to begin. All checks
submitted as License fees must be made payable to the California Department of
Health Services and remitted with your application.
Non-prescription drug manufacturers must only complete and submit the Drug
Manufacturing License Application (EH 52) and appropriate fees. Non-prescription drug
manufacturers are NOT required to submit the Disclosure Statement nor provide
fingerprint scans.
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