Posted by SLS on March 17, 2005, at 20:23:02
In reply to Re: Can't find info. on Valdoxan..., posted by med_empowered on March 15, 2005, at 14:17:49
I'll let the lawyers out there interpret this.
- Scott
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FDA:
RPM Chapter 9, Subchapter Personal importationsSUBCHAPTER
COVERAGE OF PERSONAL IMPORTATIONS
PURPOSE
To provide guidance for the coverage of personal-use quantities of
FDA-regulated imported products in baggage and mail and to gain the
greatest degree of public protection with allocated resources.BACKGROUND
Because the amount of merchandise imported into the United States in
personal shipments is normally small, both in size and value,
comprehensive coverage of these imports is normally not justified. This
guidance clarifies how FDA may best protect consumers with a reasonable
expenditure of resources.There has always been a market in the United States for some foreign made
products that are not available domestically. For example, individuals of
differing ethnic backgrounds sometimes prefer products from their
homeland or products labeled in their native language to products
available in the United States. Other individuals seek medical treatments
that are not available in this country. Drugs are sometimes mailed to
this country in response to a prescription-like order to allow
continuation of a therapy initiated abroad. With increasing international
travel and world trade, we can anticipate that more people will purchase
products abroad that may not be approved, may be health frauds or may be
otherwise not legal for sale in the United States.In addition, FDA must be alert to foreign and domestic businesses that
promote or ship unapproved, fraudulent or otherwise illegal medical
treatments into the United States or who encourage persons to order these
products. Such treatments may be promoted to individuals who believe that
treatments available abroad will be effective in the treatment of serious
conditions such as AIDS or cancer. Because some countries do not regulate
or restrict the exportation of products, people who mail order from these
businesses may not be afforded the protection of either foreign or U.S.
laws. In view of the potential scale of such operations, FDA has focused
its enforcement resources more on products that are shipped commercially,
including small shipments solicited by mail-order promotions, and less on
those products that are personally carried, shipped by a personal
non-commercial representative of a consignee, or shipped from foreign
medical facility where a person has undergone treatment.PERSONAL BAGGAGE
FDA personnel are not to examine personal baggage. This responsibility
rests with the U.S. Customs Service. It is expected that a Customs
officer will notify their local FDA district office when he or she has
detected a shipment of an FDA-regulated article intended for commercial
distribution (see GENERAL GUIDANCE below) an article that FDA has
specifically requested be detained, or an FDA regulated article that
appears to represent a health fraud or an unknown risk to health.When items in personal baggage are brought to FDA's attention, the
district office should use its discretion, on a case-by-case basis, in
accordance with the guidance provided under GENERAL GUIDANCE below, in
deciding whether to request a sample, detain the article, or take other
appropriate action.MAIL SHIPMENTS
FDA personnel are responsible for monitoring mail importations. It is
expected that a Customs officer from the Customs Mail Division will
examine a parcel and will set it aside if it appears to contain a drug,
biologic, or device, an article that FDA has specifically requested be
held, or an FDA-regulated article that appears to represent a health
fraud or unknown risk to health.FDA should audit those parcels set aside by Customs in accordance with
the guidance provided under GENERAL GUIDANCE below, using the following
procedures:Prepare a Collection Report for each parcel sampled. Generally, a
physical sample is not required on mail importations because a
documentary sample (for example, labeling, labels and inserts) will be
sufficient for most regulatory purposes. If a physical sample is needed,
collect only the minimum necessary for analysis by the laboratory. The
remaining portion should not be removed from the custody of the Customs
Mail Division.Importations detained in accordance with this guidance should be held by
Customs until they are either released or refused entry. Attached as
guidance are two specimen letters that may be sent with the Notice of
Detention and Hearing when a parcel is detained. (See Exhibit 9-3 for use
in general mail importations and Exhibit 9-4 for use in unapproved drug
or device mail importations).On occasion, products detained by FDA will be mixed with
non-FDA-regulated products. When we refuse admission of the FDA-regulated
portion, any request for the release of the non-FDA-regulated portion
should be referred to the Customs Mail Division with a Notice of Refusal
of Admission covering the detained article. Final disposition of all
merchandise, including the destruction of detained merchandise, is the
responsibility of Customs.GENERAL GUIDANCE
The statements in this chapter are intended only to provide operating
guidance for FDA personnel and are not intended to create or confer any
rights, privileges, or benefits on or for any private person.FDA personnel may use their discretion to allow entry of shipments of
violative FDA regulated products when the quantity and purpose are
clearly for personal use, and the product does not present an
unreasonable risk to the user. Even though all products that appear to be
in violation of statutes administered by FDA are subject to refusal, FDA
personnel may use their discretion to examine the background, risk, and
purpose of the product before making a final decision. Although FDA may
use discretion to allow admission of certain violative items, this should
not be interpreted as a license to individuals to bring in such shipments.Commercial or Promotional Shipments
Commercial and promotional shipments are not subject to this guidance.
Whether or not a shipment is commercial or promotional may be determined
by a number of factors including, for example, the type of product,
accompanying literature, size, value, and/or destination of the shipment.
FDA personnel may also consider whether an importation of drugs or
medical devices is a commercial shipment by evaluating whether the
article appears to have been purchased for personal use or whether the
quantity suggests commercial distribution (i.e., the supply exceeds what
one person might take in approximately three months). Commercial
shipments generally include shipments other than those products that are
personally carried, shipped by a personal non-commercial representative
of a consignee, or shipped from a foreign medical facility where a person
has undergone treatment.Products Other than Drugs and Devices
Many products other than drugs, biologics, and devices that individuals
seek to import in personal quantities do not pose a significant health
risk although they appear to be violative and may be the subject of an
import alert or automatic detention based on standards violations, filth,
and/or labeling problems. When such items are brought to FDA's attention
by Customs, it may be appropriate for FDA personnel to use their
discretion to "Release with Comment" and advise the importer of the
agency's concerns. FDA personnel should be alert to and should detain
those products that do pose a significant health risk.Drugs, Biologics, and Devices
When personal shipments of drugs and devices that appear violative are
brought to FDA's attention by Customs, FDA personnel will use their
discretion to decide on a case by case basis whether to detain, refuse,
or allow entry of the product. Generally, drugs and devices subject to
Import Alerts are not amenable to this guidance. Devices to be used by
practitioners for treating patients should not be viewed as personal
importations subject to this chapter. Drugs subject to Drug Enforcement
Agency (DEA) jurisdiction should be returned to Customs for handling.In deciding whether to exercise discretion to allow personal shipments of
drugs or devices, FDA personnel may consider a more permissive policy in
the following situations:1. when the intended use is appropriately identified, such use is not for
treatment of a serious condition, and the product is not known to
represent a significant health risk; or2. when:
a) the intended use is unapproved and for a serious condition for
which effective treatment may not be available domestically either
through commercial or clinical means;b) there is no known
commercialization or promotion to persons residing in the U.S. by those
involved in the distribution of the product at issue;c) the product is
considered not to represent an unreasonable risk; andd) the individual
seeking to import the product affirms in writing that it is for the
patient's own use (generally not more than 3 month supply)and provides
the name and address of the doctor licensed in the U.S. responsible for
his or her treatment with the product, or provides evidence that the
product is for the continuation of a treatment begun in a foreign
country.If there are any questions about the application of these factors to any
product, the product should be detained and FDA personnel should consult
with the appropriate headquarters office.When a shipment is not refused entry, FDA personnel may consider issuing
a "Release with Comment" and, as appropriate, advise the recipient that
1) the drug (or device) that has been obtained for personal use appears
to be unapproved in the United States; 2) the drug (or device) should be
used under medical supervision; 3) FDA may detain future shipments of
this product; and 4) the patient's physician should consider for example,
enrolling the patient in an Investigational study or applying for
Investigation New Drug (IND), Compassionate IND, or Treatment IND
exemption.IMPORT ALERTS
FDA personnel should recommend to the Division of Import Operations and
Policy (HFC-170) the issuance of an import alert if they encounter:1. personal importation of products that represent either a direct or
indirect health risk; or2. the promotion of unapproved foreign products for mail order shipment;
or repeated importation of products that represent fraud*.*(See Compliance Policy Guides Manual, Section 120.500,"Health Fraud -
Factors in Considering Regulatory Action" (CPG 7150.10))--------------------------------------------------------------------------
poster:SLS
thread:470714
URL: http://www.dr-bob.org/babble/20050317/msgs/472266.html