S. 2221: Titled the Transparency in Medical Device Pricing Act of 2007, this bill seeks to amend title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable medical devices. This bill is sponsored by Senators Grassley (R-IA) and Specter (R-PA).
H.R. 3610: Titled the Food and Drug Import Safety Act of 2007, this bill seeks to amend the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to provide for research on the development of tests and sampling methodologies for use on imported food.
If enacted, beginning in fiscal year 2008, the Secretary will be required to assess and collect user fees on imported drugs. These fees will be assessed on each line item of drugs, which shall not exceed $1,000 per line item. In addition, the Secretary will be empowered to require the country of origin labeling on all imported drugs and devices.
H.R. 970: The Dextromethorphan Distribution Act of 2007: This act seeks to amend the Federal Food, Drug, and Cosmetic Act regarding restrictions on bulk distribution of the drug dextromethorphan.
H.R. 493: Genetic Information Nondiscrimination Act of 2007: This act seeks to prohibit discrimination on the basis of genetic information with respect to health insurance and employment.
S. 558: Mental Health Parity Act of 2007: This act seeks to provide parity between health insurance coverage of mental health benefits and benefits for medical and surgical services.
H.R. 1236: This legislation seeks to extend the authority of the U.S. Postal Service to issue a special postage stamp for first class mail that costs not less than 15% more than the regular first-class stamp to contribute funding towards breast cancer research.
S. 980: seeks to amend the Controlled Substances Act relating to the delivery of controlled substances by means of online pharmacies.
S. 2071: Amends the Controlled Substances Act to: (1) require all regulated sellers and persons dealing in certain listed chemicals used to make meth. to file self-certifications with the Attorney General in compliance with such Act; (2) requires the Attorney General to publish a list of all self-certified persons on the website of the Drug Enforcement Administration (DEA); (3) restricts distributors of listed chemicals from selling to individuals other than self-certified regulated sellers or persons; and (4) imposes penalties for negligent failure to self-certify.
S. 3101: titled the Medicare Improvements for Patients and Providers Act of 2008, seeks to address the physician reimbursement cuts.
With regards to pharmacists, this bill would require PBMs to pay pharmacies within 14 days of receipt of a clean claim. In addition, there would be a provision delaying the effective date on the use of FULs of multi-source generic drugs until September 30, 2009, while temporarily suspending the online publication of AMP data until at least September 30, 2009.
H. R. 6252: titled the Medicare DMEPOS Competitive Acquisition Reform Act of 2008 seeks to delay and reform the Medicare competitive acquisition program for the purchase of DME, prosthetics, orthotics and supplies for 18 months. However; this bill would require cuts in expected consumer price index increases for the DME items. Retail diabetes supplies are currently exempt from competitive bidding at this time.
-CALIFORNIA-
S.B. 1476:
Commencing on January 1, 2009, a wholesaler or pharmacy may not sell, trade, or transfer a dangerous drug at wholesale without providing a pedigree. These entities may not acquire a dangerous drug without receiving a pedigree.
A pedigree is a record in electronic form with information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers or pharmacies until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug. The pedigree tracks each dangerous drug at the smallest package or immediate container. The pedigree must be maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution. This system means electronic track and trace that uses an unique ID #, established by the manufacturer and contained in a standardized nonproprietary data format and architecture.
The legislation does allow the Board to extend the 1/1/2009 compliance deadline to 1/1/2011 if the Board deems it necessary.
California S.B. 1307: Manufacturers, wholesalers, repackagers and pharmacies must provide a pedigree for each dangerous drug distributed.
Timeline for passing pedigree: From 1/1/11 through 12/31/14, wholesalers and pharmacies shall initiate steps to accept and pass electronic pedigrees for all dangerous drugs. Full compliance should be in place by 1/1/15.
Grandfathering: This language has been amended. Wholesalers must notify the Board in writing within 30 days after the operative date of dangerous drugs that they currently have in their inventory. Information that wholesalers provide to the Board will be kept confidential as the information will be classified as a “trade secret.” Lot numbers and the NDC # should be included in the written declaration of the drug to the Board.
Inference: Wholesalers may infer the contents of a case. If wholesalers choose to do so, they must document their process and procedures in a Standard Operating Procedure and wholesalers must have these SOPs available for Board review. This SOP must include a process for statistically sampling the accuracy of information sent with inbound product. The Board will establish regulations that will outline potential wholesaler liability when using inference.
Returns: All dangerous drugs that wholesalers and their pharmacy customers possess and where the manufacturer does not have legal title, will not be subject to the pedigree requirement on the effective date. However; if wholesalers retur
CA S.B. 1270: This bill seeks to establish an electronic pedigree task force that will submit an annual report regarding its findings to the Board of Pharmacy and the overseeing committee in the state legislature. One member from each of the several healthcare industry trade associations will comprise industry representation. The task force will cease to exist on July 1, 2012.
-FLORIDA-
Florida H.B. 371:
Effective July 1, 2006 (regulations pending ) all pharmaceutical drug wholesalers must pass a pedigree before each transaction. Direct purchase pedigree can be used in transactions from the manufacturer to the distributor to a pharmacy/chain pharmacy warehouse or dispenser. Florida does allow for paper or electronic pedigree.
Regarding returns, when there is a mistake in an order or shipment, the return of that shipment by the authorized recipient to the wholesaler need not be reflected in the pedigree paper. A mistake in ordering or shipment shall be deemed to have occurred if within seven calendar days after the date of receipt of the original shipment: the authorized recipient ships the specific unit of the Rx back to the wholesaler from which the specific unit was purchased; or the authorized recipient transmits a documented communication to the wholesaler from which the Rx was purchased stating the authorized recipient’s intent to return the shipment in accordance with the wholesaler’s written policies and procedures and the wholesaler communicates authorization for return of the product.
Drop shipments: The manufacturer, distributor, and the end user or member of an affiliated group each have specific obligations in a drop shipment transaction: They manufacturer must provide, and the end user must acquire a shipping document within 14 days after the receipt of the prescription drug. The wholesaler must provide an invoice and a sworn statement t
-TEXAS-
Enacted during the 2007 legislative session, S.B. 943 uses the normal distribution model. In Texas, the normal distribution model means a chain of custody for an Rx either directly or by drop shipment, from the manufacturer of the prescription drug, the manufacturer to the manufacturer’s co-licensed product partner, manufacturer to manufacturer’s 3PL, or manufacturer to the manufacturer’s exclusive distributor, to (i) a patient or (ii) another designated person authorized by law to dispense or administer the drug to a patient (B) an ADR to (i) a pharmacy to a patient, or (ii) another designated person authorized by law to dispense or administer the drug to a patient; (C) an ADR to a pharmacy warehouse to the pharmacy warehouse’s intracompany pharmacy. (D) pharmacy warehouse to the pharmacy warehouse’s intracompany pharmacy or another designated person authorized by law to dispense or administer the drug to a patient; (E) a person authorized by law to prescribe an Rx that by law may be administered only under the supervision of the prescriber; or (F) an ADR to one other ADR to a licensed practitioner for office use.
Drop shipment is included in the normal distribution model. Pedigrees shall be provided for every Rx that leaves the normal distribution channel. Returns are governed by the contractual terms and agreements between the pharmacy and wholesaler.
Implementing rules are currently being developed.
-KENTUCKY-
S.B. 118: This bill requires wholesale distributors to provide a pedigree for any prescription drug that leaves the normal distribution channel. Furthermore, the legislation prohibits the Board of Pharmacy from requiring the use of an electronic track and trace system for pedigrees until the federal government establishes standards for electronic identification, validation and authentication of prescription drugs.
KY H.B. 7: Requires the Governor, in coordination with the Cabinet for Health Services, to request that the Secretary of the U.S. Department for Health and Human Services certify to Congress that drug importation from foreign countries by KY licensed pharmacists, distributors, and wholesalers poses no additional risk to the public's health and safety and would result in cheaper Rx costs.
Furthermore, the bill calls for a design of an Rx program to facilitate the importation of Rx drugs from foreign countries by licensed pharmacists, distributors, and wholesalers in KY.
-NEVADA-
This bill requires wholesalers and manufacturers who employ a person to sell or market a drug, medicine, chemical, device or appliance in this State to adopt a written marketing code of conduct. This bill also requires a wholesaler or manufacturer to adopt a training program and policies and procedures, identify a compliance officer, conduct an annual audit and submit an annual report certifying the wholesaler’s or manufacturer’s compliance with the marketing code of conduct.
Implementing regulations are currently being drafted.
-NEW HAMPSHIRE-
NH S.B. 514: A manufacturer or wholesaler shall not offer for final sale in this state, sell at a final sale in this state, or distribute in this state any health product that contains mercury, unless the product is labeled. All labels shall be legible and shall inform the purchaser, using words or symbols, in a minimum of 10-point font, that mercury is present in the product and shall clearly identify that the mercury-added product should not be disposed of or placed in a waste stream destined for disposal until the mercury is removed and reused, recycled, or otherwise managed to ensure that the mercury in the product does not become mixed with other solid waste or wastewater.
Component, product, and package labels shall be placed so that they are clearly visible. A label shall also be visible prior to sale. By no later than October 1, 2008, each manufacturer required by this subdivision to label shall certify to the department that it has developed a labeling plan for its mercury-added products that complies with this section, and that this labeling plan shall be implemented for products offered for final sale, sold at final sale, or distributed in New Hampshire after January 1, 2009.
-NEW JERSEY-
Effective 2/6/06: Before the sale or return of an Rx drug to another wholesaler, a selling wholesaler shall provide a pedigree or certification (1) if the seller is an ADR, a pedigree for each Rx that is included on the specified list of susceptible products and was not purchased directly from the manufacturer, or (2) if the seller is neither the manufacturer or ADR, a pedigree for each distributed Rx.
Returns: Pharmacies must physically return prescription drugs within 30 business days of notification to the distributor or returns must be consistent with the distributor’s return policy. If this is not feasible, the drug shall be returned to the manufacturer. The Department shall be notified of any returns.
Each distributor shall authenticate every distribution of an Rx back to the manufacturer if the distributor believes that the Rx purchased from another distributor is damaged, adulterated, misbranded, etc. Distributors must conduct annual random authentications on at least 10% of pedigrees required by law, and on at least 90% of the pedigrees for Rx’s designated on a specified list of susceptible products for which pedigree is required.
-WASHINGTON-
WA H.B. 3064: Requires manufacturers and distributors to participate in the newly created "Producer Drug Stewardship Program," which targets the disposal of unwanted drugs from residential sources. Drug wholesalers must check with the Board of Pharmacy website to determine if producers of products they are wholesaling in or into this state are in compliance. Heavy fines will be imposed on those not compliant with this proposal.
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