IA #66-72, IMPORT ALERT #66-72, ADETENTION WITHOUT PHYSICAL EXAMINATION
OF MISBRANDED DRUGS AND MARKETED NEW DRUGS WITHOUT APPROVED APPLICATIONS@
ATTACHMENT B 3/30/07 ATTACHMENT C 5/4/07 ATTACHMENT D 8/7/07 ATTACHMENT E
11/21/07
TYPE OF ALERT: Detention Without Physical Examination (DWPE) of finished drug
products and Active Pharmaceutical Ingredients (APIs)
NOTE: This import alert contains the Agency's current guidance to FDA field
personnel regarding the manufacturer(s) and/or product(s) at issue. It
does not create or confer any rights for or on any person and it does
not operate to bind FDA or the public.
PRODUCT: See attachments
PRODUCT CODE: See attachments
PROBLEM: Unapproved new drugs; Misbranded drugs
PAC: 56008H
PAF: LBL, AAP
COUNTRIES: All
MANUFACTURER/SHIPPER: All. Please see guidance for exceptions.
CHARGES: For finished drug products: AThe article is subject to refusal of
admission pursuant to Section 801(a)(3) in that it appears to be a new drug
within the meaning of Section 201(p) without an effective new drug application
(NDA)[Unapproved New Drug, Section 505(a)".]
and/or
"The article is subject to refusal of admission pursuant to section 801(a) (3)
in that it appears to be misbranded in that it lacks adequate directions for
its intended use. [Misbranding, Section 502(f) (1)]."
For all active pharmaceutical ingredients (APIs), including those APIs
intended for use in pharmaceutical compounding: AThe article is subject to
refusal of admission pursuant to section 801(a)(3) of the FDCA because it
appears to be misbranded in that it lacks adequate directions for its intended
use and it is not exempt from this requirement. (Misbranding, section 502(f)
(1) of the FDCA)
OASIS CHARGE CODE: UNAPPROVED; DRUGS DIRECTIONS
RECOMMENDING OFFICE: CDER, OC, Division of New Drugs and Labeling Compliance
(HFD-310)
REASON FOR ALERT:
As part of its ongoing drug safety initiative, FDA issued a final guidance
document, announced in the Federal Register at 71 FR 33466 -33467 (June 9,
2006), outlining its enforcement approach to drugs that are marketed without
required FDA approval. The guidance may be found at
http://www.fda.gov/cder/guidance/6911fnl.htm
Background:
For a variety of historical reasons, some drugs, mostly older products,
continue to be marketed illegally in the United States without required FDA
approval. FDA=s guidance document on marketed unapproved drugs clearly
articulates the agency=s expectation that manufacturers of products requiring
FDA approval submit applications showing that their products are safe and
effective. The guidance also outlines the agency=s enforcement policies aimed
at efficiently and rationally bringing these drugs into the approval process.
This approach includes efforts to identify illegally marketed drugs,
prioritization of those drugs according to potential public health concerns or
other impacts on the public health, and subsequent regulatory follow-up._ _
Many marketed unapproved new drugs are imported into the U.S. Others are
manufactured domestically using imported APIs. As unapproved new drug
products are identified and selected for enforcement action, the finished
unapproved products and/or the APIs used in their manufacture may be included
in this alert. The finished products and APIs listed in the alert should not
be allowed entry into the U.S. unless they comply with the exceptions listed
below. The products subject to this import alert will be identified and
covered by separate attachments to this alert.
GUIDANCE:
Districts may detain without physical examination all shipments of unapproved
finished drug products and all shipments of APIs intended for the manufacture
of unapproved finished drug products that are identified in the attachments to
this alert.
Exceptions include:
(1) Finished drug products that are covered by approved applications (NDA or
ANDA);
(2) Finished drug products that are covered by an Investigational New Drug
Application (IND);
(3) APIs that are intended for use in the manufacture of finished drug
products that are subject to approved applications, under the conditions set
forth in 21 CFR ' 201.122(a);
(4) APIs that are intended for use in the manufacture of an investigational
new drug, under the conditions set forth in 21 CFR ' 201.122(b);
(5) APIs that are intended for use in the manufacture of finished drug
products subject to a pending application, under the conditions set forth in
21 CFR ' 201.122(c);
Note: Districts should contact Ada Irizarry, CDER Import-Export Team at
301-827-8967, if they cannot confirm in CDER=s databases that an approved
application or an IND covers the shipment of a finished drug product, or that
an approved or pending application, or an IND covers the shipment of an API.
(6) APIs that are intended solely for tests in vitro or in animals used only
for laboratory research, under the conditions set forth in 21 CFR ' 312.160,
and
(7) APIs that will be used in teaching, law enforcement, research, and
analysis under the conditions set forth in 21 CFR ' 201.125;
Note: Importers of APIs that claim to fall within exceptions (6) or (7) should
provide documentation establishing that the product meets the conditions set
forth in 21 CFR '' 312.160 or 201.125.
Other
(1) APIs intended for pharmacy compounding: Districts should contact Samia
Nasr, CDER=s Pharmacy Compounding Team at 301-827-8950, for further
instructions when reviewing entries of APIs identified in the attachments to
this alert that are intended for pharmacy compounding.
(2) APIs for use in the manufacture of drugs intended to generate data for the
submission of an application (pre-submission batches): Districts should
contact Ada Irizarry, CDER Import-Export Team when reviewing entries of APIs
identified in the attachments to this alert that are intended for
pre-submission batches.
If the District Offices have questions concerning this alert they should
contact CDER/OC/DNLC or ORA/ORO/DIOP/immediately.
Ada Irizarry 301-827-8967
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging required
KEYWORDS: Carbinoxamine, API, Carbinoxamine Maleate
Carbinoxamine tannate
PREPARED BY: Nawab A. Siddiqui, DIOP, 301-594-3871
Ada Irizarry /CDER/OC/DNLC 301-827-8967
DATE LOADED
INTO FIARS: March 2, 2007
ATTACHMENT A: "DETENTION WITHOUT PHYSICAL EXAMINATION OF CARBINOXAMINE
PRODUCTS@
PRODUCT: Carbinoxamine finished products and active pharmaceutical ingredients
(APIs)
PRODUCT CODE: 61X[][] 05
ATTACHMENT B: "DETENTION WITHOUT PHYSICAL EXAMINATION OF QUININE PRODUCTS"
(3/30/2007)
PRODUCTS: Quinine Sulfate finished drug products and active
quinine pharmaceutical ingredients; including quinine,
quinine sulfate, or any salt of quinine for drug use.
PRODUCT CODE(S): 62L[][]36
62L[][]37
62L[][]38
Districts may detain without physical examination all shipments of quinine,
quinine sulfate, or any salt of quinine for drug use that do not meet the
criteria established in the guidance section of this import alert.
Note: Until June 12, 2007, unapproved finished drug products containing
quinine, quinine sulfate, and any other salt of quinine may be imported
provided the product has been listed with FDA by December 15, 2006. After
June 12, 2007, no unapproved finished drug products containing quinine,
quinine sulfate, and any other salt of quinine may be allowed entry. Please
contact CDER for questions.
ATTACHMENT C: "DETENTION WITHOUT PHYSICAL EXAMINATION OF TRIMETHOBENZAMIDE
HYDROCHLORIDE SUPPOSITORIES" (5/4/07)
PRODUCTS: Trimethobenzamide Hyrdochloride Suppositories, finished
product, and Active Pharmaceutical Ingredients (APIs);
Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz.
PRODUCT CODE(S): 61T-M20
61T-S20
Manufacturer/
Shipper: All
Starting May 9, 2007, districts may detain without physical examination all
shipments of Trimethobenzamide Hydrochloride Suppositories.ATTACHMENT D: ADETENTION WITHOUT PHYSICAL EXAMINATI
ON OF UNAPPROVED ERGOTAMINE
CONTAINING DRUG PRODUCTS@ (7/30/2007)
PRODUCTS: Drug products containing ergotamine tartrate
PRODUCT CODE(S): 60L[][]80
Districts may detain without physical examination all shipments of ergotamine
which do not meet the criteria established in the guidance section of this
import alert.
Note: Until August 24, 2007, unapproved finished drug products containing
ergotamine may be imported provided the product had been listed with FDA on or
before April 27, 2007. After August 24, 2007, no shipments unapproved
ergotamine may be allowed entry. Please contact CDER, Import/Export Team, for
questions.
ATTACHMENT E: "DETENTION WITHOUT PHYSICAL EXAMINATION OF HYDROCODONE PRODUCTS"
(11/21/2007)
PRODUCTS: Drug products containing hydrocodone bitartrate, or any other salt
or ester of hydrocodone
PRODUCT CODE(S): 62U[][]13 ; 62U[][]21
Districts may detain without physical examination all shipments of hydrocodone
bitartrate, or any other salt or ester of hydrocodone for drug use which do
not meet the criteria established in the guidance section of this import
alert.
Any firm marketing any unapproved hydrocodone drug products must stop
manufacturing such products on or before December 31, 2007.
Note: Until March 31, 2008, unapproved finished drug products containing
hydrocodone bitartrate, or any other salt or ester of hydrocodone may be
imported provided the product had been listed with FDA on or before October 1,
2007. After March 31, 2008, no shipments of unapproved hydrocodone bitartrate,
or any other salt or ester of hydrocodone may be allowed entry.
Please contact CDER, Import/Export Team, for questions.
|
