• PERMITS IMPORTATION OF Rx DRUGS FROM 25 COUNTRIES. 

This House bill (H.R. 328) expands the list of countries from which importation of prescription drugs would be allowed.  (Current law would allow importation from Canada only.)  Importation would be allowed from any country that is listed in Sec. 802(b)(1)(A) of the Federal Food, Drug and Cosmetic Act [21 U.S.C. 382(b)(1)(A)].  That list currently includes 25 industrialized countries.  The bill also authorizes the Secretary of Health and Human Services (HHS) to add to this list any country, union, or economic area that has a “pharmaceutical infrastructure” which is substantially equivalent or superior to that in the U.S. (or to strike any country, union, or economic area that lacks such a pharmaceutical infrastructure).

• PERMITS IMPORTATION BY PHARMACISTS AND WHOLESALERS AS WELL AS INDIVIDUALS.

Current law requires the Secretary of HHS to issue regulations permitting the importation, by pharmacists and wholesalers, of prescription drugs from Canada into the U.S.  (21 U.S.C. Sec. 384(b)).   This bill, unlike current law, also would permit the importation of drugs by individuals (not just pharmacists and wholesalers).  This bill (unlike current law) also imposes a deadline, of 180 days after the bill’s enactment, by which these regulations must be promulgated.     

• CONTAINS MULTIPLE PROVISIONS TO ENSURE SAFETY OF IMPORTED DRUGS:

Safeguards against Adulteration/Misbranding.  Current law already requires that safeguards be in place to ensure that an imported drug product is not adulterated or misbranded, and that it is safe and effective for its intended use.  The bill preserves these requirements.  (Thus, under the bill, all imported drugs must meet the same safety and efficacy standards as drugs approved for sale in the U.S., and imported drugs must not be adulterated or misbranded.)  The bill also preserves the HHS Secretary’s authority, under current law, to adopt any additional measures that are needed to either protect public health or facilitate the importation of drug products. 

• Requirements for Importers. 

The bill preserves most of current law’s requirements for drug importers.  Thus, a drug importer would have to provide any information the Secretary deems  necessary to ensure public health, including information about the drug product (drug name and quantity, dosage form, date shipped, the amount shipped, information about drug’s origin and destination, drug manufacturer’s lot or control number).  The importer would also have to certify that the drug is FDA-approved, properly labeled, not adulterated, and not misbranded; and provide laboratory records of authenticity testing, where required (including data, and evidence that testing was conducted in a qualifying laboratory).

• Counterfeit Resistant Technologies.  

Under the bill, prescription drugs’ packaging must  incorporate either (1) overt optically variable counterfeit-resistant technologies, or (2) other technologies determined by the Secretary to have an equivalent function of security.  Such technologies must:  (1) be visible to the naked eye, providing for visual identification of product authenticity; (2) be similar to that used by Bureau of Engraving & Printing for U.S. currency; (3) be manufactured and distributed in a highly secure, tightly controlled environment; and (4) incorporate additional layers of non-visible covert security measures including forensic capability.   Drug manufacturers must incorporate these technologies into multiple elements of the physical packaging of the drugs, including blister packs, shrink wrap, labels, seals, bottles and boxes.

• Drug Testing Requirements.    

Under the bill, if a prescription drug is packaged and shipped using state-of-the-art counterfeit-resistant technologies (specified above), then testing of an imported drug product is not required.  Conversely, if such counterfeit-resistant technologies are not used for an imported drug product, then the bill makes the drug subject to the testing requirements which already exist under current law.  The drug importer or manufacturer must conduct the required authenticity testing at a qualified U.S. laboratory.

• Requirements for Foreign Sellers.   

This bill would significantly enhance the registration requirements, under current law, for exporters of qualifying drugs.
-- Each exporter, or foreign seller, must register the following information with the HHS Secretary:  its name; all places of business that relate to qualifying drugs, including each warehouse or other facility owned or controlled by, or operated for, the exporter;
-- Each exporter must agree, as a condition of registration, to make its places of business (including warehouses and other facilities owned or controlled by, or operated for, the exporter) and records available to the HHS Secretary for on-site inspections, without prior notice, for the purpose of determining whether the exporter has complied with the bill’s requirements. 
-- A registered exporter must agree to export only qualifying drugs; to export only to persons authorized to import the drugs; to notify the HHS Secretary of a recall or withdrawal of a qualifying drug distributed in a permitted country that the registrant has exported or imported, or intends to export or import to the U.S.; to monitor compliance with registration conditions and report any noncompliance promptly; to submit a compliance plan showing how the registrant will correct violations, if any; and to promptly notify Secretary of changes in its registration information. 
-- Finally, the bill authorizes HHS to inspect warehouses and other facilities and records of importers and registered exporters as often as they deem necessary to ensure compliance with the bill’s safety requirements.

• REGISTRATION FEES. 

The Secretary of HHS must establish a registration fee program under which an exporter of drugs will pay an annual registration fee to the Secretary.   Fees collected must be used solely for enforcing the bill’s provisions.  The bill imposes a cap on the total amount of fees that can be collected.