One of many reasons public health should be a priority:

FDA Withholds List of Chinese Heparin Suppliers From Probe
Wall Street Journal

WASHINGTON -- The Food and Drug Administration is withholding a list of Chinese heparin suppliers requested by congressional investigators looking into problems with tainted supplies of the blood thinner, saying confidentiality agreements prevent release of the companies' names.

Members of Congress also are concerned that Chinese heparin manufacturers and their raw-material suppliers didn't fully cooperate with an FDA inspection team in February, after the heparin crisis erupted internationally, and barred the FDA from complete access to some workshops, records and workers.

An FDA compliance official testified to a congressional subcommittee April 29 that the FDA could try to revisit facilities in China, but said, "I cannot say whether they will admit us or not, or whether they will allow us to do a full inspection."

Tensions between congressional Democrats and the FDA over the agency's handling of the heparin problem and its willingness to disclose information have escalated in recent weeks.

"The FDA thinks they have it under control, but they really don't," said the congressman leading the investigation, Rep. Bart Stupak (D., Mich.). The FDA's reluctance to release the Chinese companies' names is a red flag, he said. "If I was the FDA director, I'd shut down every drug coming in from China" until they were deemed safe, he said.

A spokeswoman for the FDA said the agency is looking at finding a way to give the committee the information it requested 10 days ago without violating confidentiality agreements involving proprietary information.

Mr. Stupak's House subcommittee is investigating the circumstances surrounding at least 81 deaths in the U.S. linked to tainted heparin derived from Chinese raw materials. The FDA has said it doesn't yet know how or when the contaminated ingredient, oversulfated chondroitin sulfate, was put into the supply. Agency officials have indicated that it was likely a deliberate act, possibly to stretch the supply of a profitable export.

Most of the reported problems have involved Heparin USP, given in large doses intravenously during heart surgery and kidney dialysis to prevent clotting.

In February, FDA inspectors were allowed to inspect the Changzhou SPL plant that made the main heparin ingredient for Baxter International Inc., then the largest U.S. maker of Heparin USP.

A spokeswoman for Baxter said the company "is seeking access further down the supply chain to the Chinese facilities" that feed the plant.

But in recent testimony, an FDA inspector said Chinese manufacturers barred them from complete access to two of Changzhou SPL's consolidators of crude heparin supplies. Changzhou SPL is majority owned by Scientific Protein Laboratories Inc., of Wisconsin. A spokeswoman for Baxter, Erin Gardiner, said the company also "is seeking access further down the supply chain to the Chinese facilities" that feed Changzhou SPL.

online.wsj.com/article/SB...382109.html



The FDA warning letter dated 21 April, 2008 appears below:


DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service Food and Drug Administration Silver Spring, MD 20993
APR 2 1 2008 Warning Letter Via FedEx and facsimile

Dr. Yan Wang, Ph.D.
General Manager
Changzhou SPL Company, Ltd (a/k/a "Kaipu")
3 Changhong West Road
Hutang Township, Wujin City
Changzhou China


Dear Dr. Wang:

We have completed our review of the Establishment Inspection Report (EIR) for the inspection conducted at your active pharmaceutical ingredient manufacturing facility in Wujin City, Changzhou, China by U.S. Food and Drug Administration ("FDA") , Investigator Regina T. Brown and Chemist Zi Qiang Gu on 20-26 February 2008. The inspection revealed significant deviations &om U.S. Current Good Manufacturing Practice (CGMP) in the manufacture of active pharmaceutical ingredients (API). These deviations were listed on an Inspectional Observations form (FDA-483) issued to you at the close of the inspection. These CGMP deviations cause your API to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 351(a)(2)(B)]. This section of the Act states that drugs, as defined in the Act, are adulterated when the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drugs meet the requirements of this Act as to safety and have the identity and strength and meet the quality and purity characteristics, which they purport or are represented to possess. Our review included your March 17,2008 and April 15,2008 written responses to the FDA-483 observations. We note that some corrections appear to have been implemented and that you have promised that others will soon be implemented. However, your response does not adequately address some ofthe deficiencies, as further discussed below. Specific areas of concern include, but are not limited to:

1. There is no assurance that processing steps used to manufacture heparin sodium, USP are capable of effectively removing impurities.

Our inspection disclosed that your firm lacked an adequate evaluation of the effectiveness of critical processing steps designed to remove impurities, and critical process parameters were not well defined or controlled (observation #1 of the FDA- 483).

The inspection also found that an impurity profile has not been established for the heparin sodium API (observation #2 of the FDA-483). . In your March 17,2008, response to observation #1, you state that the firm has conducted two successful process validation studies, one in 2002 and one in 2004. However, the validation studies failed to determine whether the process was capable of adequately removing identified and unidentified impurities. Your response does not include data to demonstrate that your process will consistently remove impurities, and your firm continues to lack established impurity limits for the API. It is essential that your firm establish that controls are in place for assuring the consistent performance of the processing steps to remove impurities in order to ensure the identity, quality and purity of the drugs your firm produces.

In your response, your firm acknowledges certain deficiencies in providing evaluations of critical processing steps. Please provide data from validation studies that assess whether the process is capable of consistently removing impurities, and your evaluation of the reliability of the controls used to establish and monitor performance of the processing steps.

In your March 17,2008, response to observation #2, you state that the current testing regimen for heparin sodium is consistent with industry practice reflected in the ICH Q7A Guidance (Laboratory Controls, Testing of Intermediates and APIs) which states that "Impurity profiles are normally not necessary for APIs from herbal or animal tissue origin." Although a full impurity profile may not be necessary as part of the batch-to- batch testing of certain APIs, it is necessary that specifications for impurities be established for the production of all API and that each API batch be tested for conformance to these specifications. The ICH Q7A ~ui'dance (Laboratory Controls, General Controls) states that appropriate specifications should be established for APIs, including for control of impurities. Your firm failed to establish appropriate specifications for identified and unidentified impurities for the heparin sodium API. Your firm also failed to perform adequate tests to detect impurities in this API.

In your March 17,2008, response to observation #2 your firm also states that the complexity of the investigation into the recent heparin product recalls demonstrates the difficulty of isolating and identifying impurities in heparin due to the nature of the Imixture o< ]However, the mere fact that it is difficult to isolate and identify impurities is insufficient rationale for not establishing appropriate specifications for, and routinely monitoring, impurities during production. In fact, we note that you committed in your response to include an "impurity profile update" in each DMF annual report.

Please note that it is essential for your firm to establish appropriate specifications and adequate testing to ensure the consistent removal of undesirable impurities, including those that are potentially harmful to human health.

It is your responsibility to ensure that your API meets the identity, quality and purity characteristics that it is represented to possess.

2. You fail to have adequate systems for evaluating the suppliers of heparin crude materials, and the crude materials themselves, to ensure that these materials are acceptable for use.

Our inspection found (Observation #6 of the FDA-483) that you received lots of material from an unacceptable workshop vendor that were used in your API. In your March 17,2008, response to observation #6, your firm acknowledges inadequacies in the firm's supplier qualification efforts. For example, you state that the firm received and used heparin crude materials from a workshop that had been designated by your firm in a "pre-audit" as "unacceptable" and that was ultimately not approved by your firm. Your firm used this crude material in the production of API lots that were shipped to the United States.

' Your system for evaluating suppliers of crude heparin material is ineffective to ensure that materials are acceptable for use. As described above, your firm accepted and used heparin crude material from a supplier that you had preliminarily determined was unacceptable. Your system failed to verify that the supplier was acceptable prior to the use of the crude material. Furthermore, after your firm determined that the supplier was not acceptable, your firm failed to take any corrective action with respect to the processed raw material.

All raw materials that are received and used in producing heparin sodium API should be qualified using a system to ensure that raw materials are of acceptable identity, quality and purity before use. It is important to establish appropriate specifications for these materials and to assure your suppliers provide materials meeting these specifications. These specifications should be approved by the quality unit. Your firm has failed to establish appropriate specifications for your incoming crude materials.

Your vendor qualification program should provide adequate evidence that the manufacturer can consistently provide reliable and safe materials. Suppliers should be monitored and regularly scrutinized to assure ongoing reliability. It is your responsibility to 'ensure that raw materials received are suitable and approved by the quality unit prior to use.

3. The test methods performed for heparin sodium USP have not been verified to ensure suitability under actual conditions of use.

Our inspection found (Observation #4 of the FDA-483) that you have not ensured that certain USP cornpendial test methods were verified under actual conditions of use. Specifically, you have failed to conduct adequate verification of USP compendial test methods as applied to the production of your firm's API. The data you provided in your March 17,2008, response did not include information about the suitability, accuracy, and detection limits of certain test methods for API, such as the protein test method, used by your firm. There was no indication from these data that your firm's test methods could reliably detect and quantify the presence of proteins in the finished API. In addition, your firm had not conducted suitability testing of the method to determine the limit of detectionfor the method. The suitability for use of the protein method for in-process testing was also not established.

In your March 17,2008, response to the FDA-483, you state that the firm has conducted suitability tests. In addition, you state that the test method was not verified because it was a basic cornpendial test. You assert that USP <1226>, Verification of Compendia1 Procedures, states that verification is not required for basic cornpendial test procedures that are routinely performed unless there is an indication that the compendial procedure is not appropriate for the article under test. In your response, you also state that the laboratory performed basic suitability testing on the heparin sodium API analytical method in accordance with your standard operating procedures (SOPS).

We disagree with your assertions that verification is not required for those USP test methods used by your firm. In accordance with cGMP, analytical methods should be validated unless the methods used are included in a relevant pharmacopoeia or other recognized standard reference. If the method is a cornpendial method, verification of the methods should be conducted to determine that the method is suitable for its intended use under actual conditions. We acknowledge that the USP informational chapter <1226> suggests that there is a lesser need for verification for the simplest tests such as loss on drying, residue on ignition, and pH measurements. However, these do not include the test methods at issue, including the protein test method.

Further, the ICH Q7A guidance (Good Manufacturing Practices for Active Pharmaceutical Ingredients) at section 12.8 "Validation of Analytical Methods" states clearly that "the suitability of all testing methods used should nonetheless be verified under actual conditions of use and documented." Thus, although it is not necessary to validate USP test methods, it is necessary to verify that these USP methods are suitable for the specific conditions of use. Furthermore, the suitability tests you describe in your response do not verify that the USP tests are suitable for the specific conditions of use.

Please provide data that demonstrate that the compendia1 test method has been verified and determined to be suitable under actual conditions of use.

4. Equipment used to manufacture heparin sodium USP is unsuitable for its intended use.

Our inspection team observed (Observation #7 of the FDA-483) that equipment tanks used in the finalL ]step were constructed oft 3These tanks were identified as clean. However, unidentified material was observed adhering to the inside surfaces of tanks. It was also observed that surfaces of the tank were scratched, not smooth. We also note that volume markings on the outside of the L ]tanks had tape adhered to it with markings. In addition, the cleaning method used for cleaning these tanks was not qualified.

There should be written procedures for cleaning of equipment. Cleaning procedures should contain sufficient details to enable operators to clean each type of equipment in a reproducible and effective manner. Acceptance criteria should be established and cleaning procedures should be defined and evaluated.

In your response to observation #7, you stated that theL --]tanks used in the finali step will be replaced withL 3~hisL 1will be equipped with clean-in-place system and an automated level reader. Until the new tanks arrive, you state that you will replace the existingL ]tanks with newL ]tanks and conduct cleaning validation on the new tanks using the manual cleaning methods after each cleaning.

Please provide data that show how the procedures are validated.

Your corrective action to replaceL -Jtanks are qualifie3tanks with L d and the cleaning 1is noted. However, it is your responsibility to ensure that equipment used to process heparin sodium does not meaningfully alter quality of the MI by being additive, reactive or absorptive.

Once you have installed and qualified the L 3please provide information on equipment qualification and cleaning validation for these tanks.

The inspectional observations listed on the FDA-483 and the concerns described above indicate significant deficiencies in your overall quality system. An effective quality system must assure that a firm's manufacturing operations are adequate and that the API meets its established specifications for identity, quality and purity. There should be a quality unit that is independent of production and capably discharges quality assurance and quality control responsibilities. Please respond to the FDA with your corrective action plan to address the above concerns with respect to your quality system.

The CGMP deviations identified above or on the FDA-483 issued to your firm are not to be considered an all-inclusive list of the deficiencies at your facility. FDA inspections are audits, which are not intended to determine all deviations from CGMP that exist at a firm. If you wish to ship your products to the United States, it is the responsibility of your firm to assure compliance with all U.S. standards for Current Good Manufacturing Practice.

Shipments of articles manufactured by your firm are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act [21 U.S.C. 381(a)(3)] in that the methods and controls used in their manufacture do not appear to conform to current good manufacturing practice within the meaning of Section 501(a)(2)(B) of the Act [21 U.S.C. 35 1(a)(2)(B)]. Until all corrections have been completed and FDA can confirm compliance with CGMP, this office will continue to recommend disapproval of any new applications or supplements listing your firm as the manufacturer of active pharmaceutical ingredients.

Please respond to this letter in English (including attachments) within 30 days of receipt and identify your response with FEI# 3003335664. Any future shipments of API manufactured at your 3 Changhong West Road site will be refused admission into the United States.

Please contact Anthony A. Charity, Compliance Officer, at the address and telephone numbers shown below, if you have any questions or concerns regarding this letter. U.S. Food &Drug Administration Center for Drug Evaluation and Research 10903 New Hampshire Avenue, Bldg 51, Room 3246 Silver Spring, MD 20993 Tel: (301) 796-3191; FAX (301) 847-8741

To schedule a re-inspection of your facility, after corrections have been completed and your firmis in compliancewith CGMP requirements, send your request to:

Director, Division of Field Investigation, HFC-134,5600Fisher's Lane, Rockville, MD,20857.You can also contact that office by telephone at (301) 827-5655 or by fax at (301) 443-6919.

Sincerely, s
Richard L. Friedman
Director
Division of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research

www.fda.gov/Cder/warn/2008/320-08-01.pdf

This is an Office of Regulatory Affairs Response Letter (FDA Position on Foreign Drug Imports)
www.fda.gov/ora/import/kullman.htm


{So much about the present can be learned by looking into the past}

NOTE sentence in FOOTNOTE [1]: "The legal analysis is the same for drugs imported from any foreign country."


February 12, 2003

Via Facsimile (504-524-4162)
and U.S. Mail
Robert P. Lombardi, Esq.
The Kullman Firm
P.O. Box 60118
New Orleans, LA 70160

Dear Mr. Lombardi:

I write in response to your letter to Mr. Harold Davis of this agency, dated November 8, 2002. In your letter, you state that your firm represents a number of sponsors and/or administrators of employer-sponsored health plans. You raise many questions about potential civil and criminal liability of various parties involved in importing prescription drugs from Canada.

For public health reasons, FDA is very concerned about the importation of prescription drugs from Canada. In our experience, many drugs obtained from foreign sources that purport and appear to be the same as U.S.- approved prescription drugs have been of unknown quality. We cannot provide adequate assurance to the American public that the drug products delivered to consumers in the United States from foreign countries are the same products approved by FDA.

From a legal standpoint, businesses and individuals that are involved in shipping prescription drugs to consumers in the U.S. must take many steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Practically speaking, it is extremely unlikely that a pharmacy could ensure that all of the applicable legal requirements are met.

If parties are involved in violations of the Act, there are many potential avenues of liability. A court can enjoin violations of the Act. A person who violates the Act can also be held criminally liable. Those who can be found civilly and criminally liable under the Act include all who cause a prohibited act. Those who aid and abet a criminal violation of the Act, or conspire to violate the Act, can also be found criminally liable.



Factual Scenario

You ask us about the potential liability of various participants in the following factual scenario:

* A health plan's sponsor amends a health plan to include coverage for prescription drugs purchased outside of the United States.
* The health plan's administrator publicizes this change to plan members.
* A health plan member in the United States obtains a valid prescription from a licensed U.S. physician and forwards the prescription to Expedite-Rx, a company that performs technological services for SPC Global Technologies, Ltd. ("SPC"), a claims processing company.
* Expedite-Rx receives the prescription, performs certain data entry services and forwards the prescription, along with ancillary patient-protective information, to a licensed pharmacy in Canada.
* In Canada, a Canadian doctor rewrites the prescription.
* A Canadian pharmacy then fills the prescription and ships the drugs directly to the patient in the United States.
* Neither the employer, SPC, nor Expedite-Rx handles the drugs.
* Expedite-Rx consolidates the plan and patient co-pays and forwards the payment to the Canadian pharmacy.
* The plan will not cover Cipro, "quack" drugs, or controlled substances from a source outside of the United States.



General Legal Framework

The starting point for our analysis is the legal framework applicable to imports of prescription drugs from Canada.[1] First, as your letter notes, even if a prescription drug is approved in the U.S., if the drug is also originally manufactured in the U.S., it is a violation of the Act for anyone other than the U.S. manufacturer to import the drug into the United States (21 U.S.C. § 381(d)(1)). We believe that virtually all drugs imported to the U.S. from Canada by or for individual U.S. consumers also violate U.S. law for other reasons. Generally, such drugs are unapproved (21 U.S.C. § 355), labeled incorrectly (21 U.S.C. § 353(b)(2)), and/or dispensed without a valid prescription (21 U.S.C. § 353(b)(1)). Thus, their shipment into the U.S. from Canada violates the Act. See, e.g., 21 U.S.C. 331(a), (d), (t). [2]

The reason that Canadian or other foreign versions of U.S.-approved drugs are generally considered unapproved in the U.S. is that FDA approvals are manufacturer-specific, product-specific, and include many requirements relating to the product, such as manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance. 21 C.F.R. ' 314.50. Frequently, drugs sold outside of the U.S. are not manufactured by a firm that has FDA approval for that drug. Moreover, even if the manufacturer has FDA approval for a drug, the version produced for foreign markets usually does not meet all of the requirements of the U.S. approval, and thus it is considered to be unapproved. 21 U.S.C. ' 355.

Virtually all shipments of prescription drugs imported from a Canadian pharmacy will run afoul of the Act, although it is a theoretical possibility that an occasional shipment will not do so. Put differently, in order to ensure compliance with the Act when they are involved in shipping prescription drugs to consumers in the U.S., businesses and individuals must ensure, among other things, that they only sell FDA-approved drugs that are made outside of the U.S. and that comply with the FDA approval in all respects, including manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance. 21 C.F.R. ' 314.50. They must also ensure that each drug meets all U.S. labeling requirements, including that it bears the FDA-approved labeling. 21 C.F.R. ' 201.100(c)(2). The drug must also be dispensed by a pharmacist pursuant to a valid prescription. 21 U.S.C. ' 353(b)(1).

Your letter mentions that 21 U.S.C. ' 384 would allow drug wholesalers and pharmacists to import prescription drugs from certain countries under certain circumstances. As noted in your letter, however, that section is not in effect. That section would only become effective if the Secretary of Health and Human Services were to certify to Congress that the section's implementation will "pose no additional risk to the public's health and safety" and will "result in a significant reduction in the cost of covered products to the American consumer." 21 U.S.C. ' 384(l). HHS Secretary Tommy Thompson and former HHS Secretary Donna Shalala both declined to make such findings.



FDA's Personal Importation Policy

There has been some confusion about whether FDA's Personal Importation policy changes the law with respect to personal imports of pharmaceuticals. This confusion is reflected in your letter. The Personal Importation policy is used to guide the agency's enforcement discretion with respect to imports by individuals of drugs for their personal use. Under certain defined circumstances, as a matter of enforcement discretion, FDA allows consumers to import otherwise illegal drugs. Under this policy, FDA permits individuals and their physicians to bring into the United States small quantities of drugs sold abroad for a patient's treatment of a serious condition for which effective treatment may not be available domestically. This approach has been applied to products that do not present an unreasonable risk and for which there is no known commercialization and promotion to persons residing in the U.S. A patient seeking to import such a product must also provide the name of the licensed physician in the U.S. responsible for his or her treatment with the unapproved drug product. See FDA Regulatory Procedures Manual, Chapter 9, Subchapter: Coverage of Personal Importations.

However, this policy is not intended to allow importation of foreign versions of drugs that are approved in the U.S., particularly when the foreign versions of such drugs are being "commercialized" to U.S. citizens. (Foreign versions are often what Canadian pharmacies offer to sell to U.S. consumers.) Moreover, the policy simply describes the agency's enforcement priorities. It does not change the law, and it does not give a license to persons to import or export illegal drugs into the United States. Although we must concede that FDA has not often prosecuted those importing illegal drugs into the United States from Canada, FDA reserves the right to do so in the appropriate circumstance.



Potential Liability

As noted in your letter, there are many potential avenues of civil and criminal liability for parties involved in violations of the Act. A court can enjoin violations of the Act. 21 U.S.C. ' 332. A person who violates the Act can also be held criminally liable. 21 U.S.C. ' 333. A misdemeanor violation of the Act is a strict liability offense. See United States v. Dotterweich, 320 U.S. 277, 284 (1943); 21 U.S.C. ' 333(a)(1). A violation that is committed with intent to defraud or mislead or after a prior conviction for violating the Act is a felony. 21 U.S.C. ' 333(a)(2). Separately, it is a felony to knowingly import a drug in violation of the reimport prohibition. 21 U.S.C. '' 333(b)(1)(A), 381(d)(1).

Those who can be found civilly and criminally liable include all who cause a prohibited act. 21 U.S.C. ' 331 ("The following acts and the causing thereof are hereby prohibited"). Those who aid and abet a criminal violation of the Act, or conspire to violate the Act, can also be found criminally liable. 18 U.S.C. '' 2, 371.

Beyond articulating these general principles, we are unable to advise you as to whether, in the factual scenario that you set forth in your letter, Expedite Rx, the plan sponsor, the plan administrator, the plan member, SPC, the Canadian pharmacy, or the Canadian doctor could be found liable under one or more of these avenues. We are reluctant to give an advisory opinion, especially because potential liability is a very fact-specific inquiry. However, any party participating in this kind of import plan does so at its own legal risk. Of course, if FDA were to take enforcement action in this scenario, our highest enforcement priority would not be actions against consumers.



Conclusion

I hope that the above discussion is helpful to you. From a public health standpoint, FDA is very concerned about the kind of scenario described in your letter. In our experience, many drugs obtained from foreign sources that purport and appear to be the same as U.S.- approved prescription drugs have been of unknown quality. FDA approves a drug based on scientific data submitted by the drug sponsor to demonstrate that the drug is safe and effective. We cannot provide adequate assurance to the American public that the drug products delivered to consumers in the United States from foreign countries are the same products approved by FDA.

Thank you for your interest in this matter. If you need additional information, please feel free to contact me.

Sincerely yours,





William K. Hubbard

Associate Commissioner for Policy and Planning





Enclosures: Personal Import Policy (Here linked to FDA Regulatory Procedures Manual, Chapter 9, Subchapter: Coverage of Personal Importations)




Footnotes:

[1] We will limit our discussion to drugs imported from Canada because your request is so limited. The legal analysis is the same for drugs imported from any foreign country.

[2] Shipping prescription drugs to consumers in the U.S. may also violate state law because, among other things, many U.S. states require that a pharmacy that ships drugs to a consumer within that state be registered with, or licensed by, the state. Obviously, we cannot analyze state law issues for you.



**************************
Excerpt taken from the link below:

Information on Importation of Drugs Prepared by the Division of Import Operations and Policy, FDA
www.fda.gov/ora/import/pipinfo.htm

The United States Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. section 331) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not been manufactured in accordance with and pursuant to an FDA approval. Under the Act, FDA may refuse admission to any drug that "appears" to be unapproved, placing the burden on the importer to prove that the drug sought to be imported is in fact approved by FDA. Absent evidence that the specific drugs sought to be imported from a foreign country have been manufactured pursuant to an approved new drug application, in the manufacturing facility permitted under the application, such drugs would appear to be unapproved new drugs subject to FDA enforcement action.


"Under the Act, FDA may refuse admission to any drug that "appears" to be unapproved, placing the burden on the importer to prove that the drug sought to be imported is in fact approved by FDA."

{this sounds awfully familiar and smells a lot like the Heparin disaster . . .}