SPECIALTY RX FACTS

18Nov/130

HR 3024 Drug Quality and Security Act Passes in the Senate on to Obama for Signature

The United States Senate voted today to pass H.R. 3204, the Drug Quality and Security Act.

The Drug Quality and Security Act creates harmonized, Federal track and trace compliance requirements for pharmaceutical product tracing, serialization and verification of products / transactions across the supply chain starting January 1, 2015.

While serialization and track and trace will be pushed out a number of years, there will be significant demands on manufacturers, Third Party Logistics Providers, Repackagers, Distributors and Providers that will kick in starting 2015.

Plan on your 2014 to be very busy for many of these requirements if you are one of these entities.

For a full text on the bill see

www.govtrack.us/congress/bills/113/hr3204/text

Next steps after the President's signature:

  • The FDA will kick off a series of key activities which will shape the final information and implementation requirements across the supply chain
  • Industry involvement in guidance/rule development and supporting standards development will be crucial!
  • Preparing for Initial Deadlines (Lot Tracing, Verification, etc.)
  • Initial Draft Guidance  (published not later than 1 year after enactment – Nov 2014)
  • Establish standards for interoperable exchange of transaction information, history and statements (paper or electronic)
  • Consider feasibility of establishing standardized documentation to be used to convey Transaction Information, Transaction History (going back to the manufacturer) and Transaction Statement to a purchaser in a single document and to facilitate the exchange of lot-level data
  • Suspect and Illegitimate Product Guidance (published not later than 180 days after enactment – April 2014)
  • Identify specific suspect product risk scenarios
  • Provide recommendations on identification of suspect/illegitimate products
  • Preparing for Serialization and Product Tracing (Unit)

 

  • FDA to hold at least 5 public meetings
  • Steps to build capabilities and capacity for unit-level product tracing and the system attributes for such a system
  1. Public Meetings
  • Standards necessary to support secure interoperable electronic data exchange
  • Systems and processes needed to utilize serialized product identifiers for product tracing
  • Unit-level Tracing:  Not later than 18 months after a public meeting on secure tracing of product at the package level
  • System attributes for unit-level tracing, use of inference and aggregation, methods for secure tracing
  • Interoperable Data Exchange:  Not later than 18 months after a public meeting on interoperable standards
  • Standards necessary for secure, interoperable electronic data exchange
  1. Uniform processes or methodologies for product tracing
  2. Protection of confidential commercial information and trade secrets
  • Utilize serialized product identifiers for product tracing (including verification, aggregation and inference)

Get ready for the immediate next steps including:

  • Aggregation and Inference
  1. Will be a hard requirement in preparing for unit-level tracing deadlines
  2. Will likely be required much earlier to support trading partners for operational efficiency in meeting product identifier/serialization requirements
  3. A typical requirement for building a harmonized global serialization approach
  • Interoperable Data Exchange
  1. FDA will be developing standards and guidance for exchange of data starting soon and extending for years
  2. Transaction information, history and statements exchange between parties
  3. Lot-level and unit-level information exchange between parties, response to verification requests
  • How will you exchange required information with direct trading partners and manage your supply network?
  • How will you verify appropriateness of and efficiently respond to potential queries from unknown supply chain parties?
  • How will you efficiently generate or receive the Transaction Information, History and Statement data for all product transactions?
  1. Is a single paper document approach viable or can an existing electronic data method be adapted?
  • Lot Tracing
  1. Record Retention and Response to Queries
  2. How will you set up an IT infrastructure or paperwork filing system to manage 6 years of records
  3. How will you set up your data archival to comply with short time windows for retrieval of Transaction Information, History and Statement to comply with Requests for Information, etc.?

D2 is here to help you sort all of this out.  Shoot us a note.

 

Filed under: STT/P No Comments
22May/130

Express Scripts Drug Trend Report: Specialty Products 1% of Products Dispensed, but 25% of the Spend.

If you have not seen it the newest edition of the Express Scripts Drug Trend Report was just published and features several highly anticipated enhancements, including a detailed forecast. In addition, the Commercial Spotlight offers in-depth insights into forecasting trend for the top therapy classes. You'll also find  proprietary annual update on the cost of pharmacy-related waste, which was $418 billion at the end of 2012. It's all online at DrugTrendReport.com.

Filed under: D2 News No Comments
25Apr/130

D2 has launched D2 STT/P Solutions™ which provides services focused on Track-Trace-Serialization-Pedigree

California SB 1307 Pedigree Law Goes into Effect in 20 Months

As you are aware, California Law SB 1307 has established dates and rules for mandatory e-pedigree requirements and serialization.  For manufacturers, the deadline for serialization of 50% of their products is January 1, 2015 - that is a little more than 20 months away.

D2 STT/P Solutions

D2 has launched D2 STT/P Solutions™ which provides services focused on Track-Trace-Serialization-Pedigree including:

Serialization-Track and Trace/Pedigree (STTP) Laws and Regulations

  • State
  • Federal
  • Key Wholesaler/Trading Partner Policies
  • 3PL capabilities
  • Service Providers
  • Serialization
  • Packaging Standards
  • Shipping Standards
  • Pending/Upcoming Enhancements
  • Regulation
  • Technology

We have formed the D2 STT/P Solutions™ to assist clients in managing pedigree including:

Providing industry expertise in conjunction with operational and manufacturing assessment in the evaluation and monitoring of compliance with the appropriate compliance standards in the supply chain; thus, ensuring your products flow through the supply channel with minimal potential disruptions.

  • Leading the review of standards utilized and implementation of distributing capabilities to assure STT/P compliance.
  • Providing ongoing distribution and management expertise in the development of certain internal and external policies and procedures.

To facilitate serialization and interoperability among trading partners, one of the first rules put forward by the Enforcement Subcommittee of the California Board of Pharmacy was the mandatory adoption of the FDA Standardized Numeric Identifier (SNI) as the “unique identifier” to be used on each drug package. At the same time, the Enforcement Subcommittee drafted a proposed rule covering the grandfathering of existing non-serialized, non-pedigreed stock that wholesalers and pharmacies must follow when SB 1307 goes into effect.

To summarize for your organization below are the highlights from the law:

A manufacturer of a dangerous drug distributed in California shall submit to the board, no later than December 31, 2014, a declaration signed under penalty of perjury by an owner, officer, or employee with authority to bind the manufacturer, containing the following:

A list and quantity of dangerous drugs by name and product package (SKU) type representing at least fifty (50) percent of the manufacturer’s total that are ready for initial implementation of the serialized electronic pedigree requirements as of January 1, 2015;

  • A statement identifying which one of the following methods was used to measure the percentage of drugs ready to be serialized: (i) unit volume, (ii) product package (SKU) type, or (iii) drug product family;
  • A statement describing the calculation(s) used to arrive at the percentage figure of dangerous drugs ready for serialized pedigree requirements;
  • A list and quantity of dangerous drugs by name and product package (SKU) type that are in the remaining percentage not yet ready to be serialized or subject to pedigree requirements; and,
  • A statement specifying the technology employed to meet the pedigree requirements, including but not limited to any platform(s), vendor(s), hardware, software, and communication technologies deployed.

A manufacturer of a dangerous drug distributed in California shall also submit to the board, no later than December 31, 2015, a declaration signed under penalty of perjury by an owner, officer, or employee with authority to bind the manufacturer, containing the following:

  • A list and quantity of its remaining dangerous drugs by name and product package (SKU) type that are ready for implementation of serialized electronic pedigree requirements as of January 1, 2016;
  • A statement identifying which one of the following methods was used to measure the final percentage of drugs to be serialized: (i) unit volume, (ii) product package (SKU) type, or (iii) drug product family;
  • A statement describing the calculation(s) used to arrive at the final percentage figure; and,
  • A statement specifying the technology employed to meet the pedigree requirements, including but not limited to any platform(s), vendor(s), hardware, software, and communication technologies deployed.

A manufacturer, wholesaler or re-packager seeking to designate dangerous drugs it possesses, owns, or controls that are not subject to the serialized electronic pedigree requirements, shall submit to the board, by no later than August 1, 2016, a declaration signed under penalty of perjury by an owner, officer, or employee with authority to bind the manufacturer, wholesaler or re-packager, containing the following summarized highlights from the law:

A manufacturer of a dangerous drug distributed in California shall submit to the board, no later than December 31, 2014, a declaration signed under penalty of perjury by an owner, officer, or employee with authority to bind the manufacturer, containing the following: A list and quantity of dangerous drugs by name, product package (SKU) type and National Drug Code (NDC) product identifier in the possession, ownership, or control of the manufacturer, wholesaler or re-packager that were acquired prior to July 1, 2016; and,

  • A statement that specifies the means and source of acquisition

While the term “grandfathered” is not used in the draft regulation, the staggering of the dates allows for manufacturer’s, wholesaler’s and re-packager’s inventory manufactured or obtained prior to the effective dates of SB 1307 to be traded so long as appropriate labeling is in place to assure compliance.

Is your company ready? To test your preparedness ask yourself these questions and determine whether you can answer them correctly.

1.     What is the difference between serialization, e-pedigree and track and trace?

2.     What are the common standards available for use to ensure interoperability among trading partners?

3.     At a practical level, what data carriers are available for manufacturers and downstream trading partners for encoding SNIs, and what are the respective benefits, costs and problems associated with each data carrier?

4.     As a manufacturer, are you intending to encode lot numbers and expiration dates into your SNI, or omit them? Why or why not?

5.     Are you prepared to find sufficient real estate on your labeling to support both a linear barcode to meet the hospital bar code rule as well as your chosen data carrier for your serialized product?

6.     If you have to change your label to accommodate both a linear bar code and a data carrier, how do you intend to inform FDA: a pre-approval supplement, or an annual report?

7.     Do you know what your third party logistics provider’s obligations are for receiving and reading serialized product under SB 1307?

8.     Aside from California, are you aware of the current status of other state legislation covering e-pedigrees? How about other countries?

9.     As a manufacturer, is your company registered in those states your products are currently being dispensed or administered in?

10.  For California law when must a manufacturer, wholesaler or pharmacy create a pedigree:

a.     When selling a drug?
b.     When acquiring a drug?
c.     When selling a drug at wholesale?

For more information contact Dan Steiber.

Filed under: D2 News, STT/P No Comments
25Apr/130

D2 STT/P Solutions Update: Pending Senate Legislation Being Reviewed for Pedigree

Last Friday, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee released a new discussion draft of a bill that would preempt all state pharmaceutical ePedigree laws and establish a pathway toward a nationwide track & trace regulation. The clock is ticking and now Congress is asking responses by Friday, April 26th. With such an aggressive timeline to hear responses prior to the hearings, perhaps this time will prove to provide National Direction.
PLEASE SEND A NOTE TO ME at dan.steiber@d2rx.com if you’d like a breakdown of the timeframes.
Here is the excerpt:
Securing Our Nation’s Pharmaceutical Distribution Supply Chain:
Section-by-Section of Bipartisan Senate Discussion Draft (Sens. Harkin, Alexander, Bennet, Burr)
Section 1: Short Title
Section 2: Pharmaceutical Distribution Supply Chain
Section 581: This section adds a new section to the Federal Food, Drug, and Cosmetic Act (FFDCA). This section sets forth definitions for this Act.
Section 582: This new section in the FFDCA sets forth lot-level product tracing requirements for “downstream” pharmaceutical supply chain members: drug manufacturers, repackagers, wholesale distributors, and dispensers. These entities will be required to pass certain information and representations about pharmaceutical transactions when there is a change of ownership. Entities in the supply chain may only accept product if this information is provided. These entities will also be required to engage in verification and notification activities in circumstances pertaining to suspect and illegitimate product. Once product is serialized, manufacturers, repackagers, and wholesale distributors are required to respond to requests to verify product at the unit level in circumstances pertaining to suspect and illegitimate product and must also verify product at the unit level for saleable returns. Third party logistics providers that warehouse or provide other logistics services, but do not take ownership of the product, will be required to accept information from the owner of the product before taking possession, and alert the owner in the case of a suspect or illegitimate product.
Entities will also be required to promptly respond to requests for information from the Secretary, or another State or Federal official, in the event of a recall or investigation of suspect or illegitimate product and keep records of investigations of suspect and illegitimate product. However, instead of imposing one-size-fits-all requirements, requirements are tailored to the supply chain members to reflect the different and unique roles that each sector plays in the pharmaceutical distribution supply chain. To further strengthen pharmaceutical supply chain security, not later than 1 year after the date of enactment of this Act, the trading partners of drug manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers must be properly registered or licensed.
The timeline for serializing product and accepting and transferring only serialized product is phased in: manufacturers in 4 years after the date of enactment of this Act; repackagers in 5 years; wholesale distributors and third-party logistics providers in 6 years; and dispensers in 7 years. This section also sets forth how grandfathered product will be addressed, both with respect to serialization and tracing requirements.
Section 3: Enhanced Drug Distribution Security
Section 582: This section further amends Section 582, as added by this Act, to require interoperable, electronic unit level product tracing 10 years after the date of enactment of this Act. The unit-level product tracing requirements are tied to guidance issued by the Secretary on unit level product tracing and standards for interoperable data exchange, which are informed by public meetings and pilot projects, and specific procedures for the issuance and revision of such guidance is set forth.
The Secretary is required to contract with a private, independent consulting firm to conduct an assessment of the feasibility of unit level product tracing requirements on dispensers with 25 or fewer full-time employees. The Secretary, taking into consideration this assessment, shall provide for alternative methods of compliance, including establishing a process by which a dispenser may obtain a waiver from any of the requirements if the Secretary determines that such requirements would result in undue economic hardship. The Secretary is also required to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. The transaction history requirements sunset 10 years after the date of enactment of the Act.

Section 4: National Licensure Standards for Wholesale Distributors
503(e)/Section 583: This section amends Section 503(e) of the FFDCA to increase the minimum wholesale distributor licensure standards under current law by regulation. Beginning 1 year after the date of enactment of the Act, any person who owns or operates an establishment that engages in wholesale distribution shall report to the Secretary, on an annual basis, regarding the State by which the person is licensed and the name and address of each facility at which the person conducts business. Not later than 1 year after the date of enactment of this Act, the Secretary shall establish a database that identifies each wholesale distributor by name, address, and the State where the wholesale distributor is licensed and make this database available on the Internet Website of the Food and Drug Administration. If a State chooses not to license a wholesale distributor to the standards set forth in the newly added Section 583 of the FFDCA, than the Secretary shall license qualified wholesale distributors in that State and collect reasonable fees to cover the costs of this licensing program. This section also makes clear that a third-party logistics provider is not required to obtain a license as a wholesale distributor.
Section 5: National Licensure Standards for Third-Party Logistics Providers
Section 584: This section sets forth new minimum third-party logistics provider licensure standards in the FFDCA. Beginning 1 year after the date of enactment of the Act, a facility of a third-party logistics provider shall report to the Secretary, on an annual basis, regarding the State by which the facility is licensed and the name and address of the facility. If a State chooses not to establish a licensing program for a third-party logistics provider, the Secretary shall licensure the third-party logistics provider and collect reasonable fees to cover the costs of this licensing program. The Secretary is required to issue regulations regarding the minimum licensure standards, including establishing a process by which a third-party accreditation program approved by the Secretary, shall upon request by a third-party logistics provider, issue a license to a third- party logistics provider that meets the minimum requirements set forth in this Act. If the Secretary is not able to approve a third-party accreditation program because no such program meets the Secretary’s requirements, than the Secretary shall issue a license to a third-party logistics provider consistent with this section.

Section 6: Penalties: This section amends Section 301(t) of the FFDCA to add failure to comply with the requirements under Section 582 and reporting under 584 as prohibited acts. It also amends Section 502 to make failure to bear a product identifier as required under section 582 a misbranding violation.
Section 7: Uniform National Policy: This section make explicit that, beginning on the date of enactment of this Act, the product tracing requirements set forth in this Act pre-empt State product tracing requirements, including paper or electronic pedigree systems. This section also makes clear that, beginning on the date of enactment of this Act, no State may establish or continue any standards, requirements, or regulations with respect to wholesale distributor or third-party logistics provider licensure requirements less stringent than the standards and requirements set forth in Sections 503(e) and 584. This section makes clear that pre-emption of product tracing shall not be construed to pre-empt State requirements related to the distribution of prescription drugs if such requirements are not related to product tracing as described in this Act.

The promise of a nationally provided guideline could be playing out before us this week. I wouldn’t put my plans to implement California Pedigree on hold just yet. With progress, come additional hope, more questions, and possible delays to implementation. Stay tuned for more information.
D2 STT/P Solutions
D2 has launched D2 STT/P Solutions™ which provides services focused on Track-Trace-Serialization-Pedigree including:
• Serialization-Track and Trace/Pedigree (STTP) Laws and Regulations
o State
o Federal
• Key Wholesaler/Trading Partner Policies
• 3PL capabilities
• Service Providers
• Serialization
• Packaging Standards
• Shipping Standards
• Pending/Upcoming Enhancements
o Regulation
o Technology

We have formed the D2 STT/P Solutions™ to assist clients in managing pedigree including:
 Providing industry expertise in conjunction with operational and manufacturing assessment in the evaluation and monitoring of compliance with the appropriate compliance standards in the supply chain; thus, ensuring your products flow through the supply channel with minimal potential disruptions.
 Leading the review of standards utilized and implementation of distributing capabilities to assure STT/P compliance.
 Providing ongoing distribution and management expertise in the development of certain internal and external policies and procedures.

2Oct/120

Get Ready Pharma for California Pedigree Rules: December 2014 Comes Quick

Note the section on first notice to the Board of Pharmacy if your company is ready for Pedigree.

Board of Pharmacy Initial Statement of Reasons
Subject Matter of Proposed Regulation:          Electronic Pedigree Requirements: Unique Identification Number; Specification of Pedigreed Dangerous Drugs; Specification of Existing Stock
Sections Affected:        Add Article 5.5 to Title 16 Cal.Code Reg. and Add § 1747 and 1747.1
Specific Purpose of the Proposed Changes:
The Board of Pharmacy (“Board”) proposes to add Article 5.5 entitled “Pedigree Requirements” to Title 16 of the California Code of Regulations (“CCR”) and to add Sections 1747 and 1747.1 related to requirements for electronic pedigrees of dangerous drugs and devices. The board’s proposal would establish the standardized numerical identifier that a drug manufacturer or repackager must establish and apply to the smallest package or immediate container of a dangerous drug or dangerous device. This proposal would also establish dates by which a manufacturer that distributes a dangerous drug or device in California shall submit to the board declarations related to the manufacturer’s readiness to comply with statutory electronic pedigree requirements. It would also set forth requirements for manufacturers, wholesalers, repackagers, pharmacies and pharmacy warehouses (as defined in Business and Professions Code section 4163(g)) to submit specified declarations to the board in order to designate dangerous drugs that they possess as “not subject” to the serialized electronic pedigree requirements.
Specifically, the Board’s proposed changes would include:
1.  The addition of a new Article 5.5 and Title “Pedigree Requirements” in Title 16 in Division 17 of the California Code of Regulations for ease‐of‐use and reference;
2.  The addition of a new definition for “unique identification number” which incorporates by reference the U.S. Food and Drug Administration’s guidance document: “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages,” dated March 2010;
3.   A requirement for each manufacturer to submit a declaration to the board by December 1, 2014 that includes a list and quantity of dangerous drugs by name and product package (SKU) type representing at least fifty percent of the manufacturer’s drugs that are ready for initial implementation as of January 1, 2015, as well as a list of dangerous drugs that are not yet ready to be serialized;
4.  A requirement for each manufacturer to state in the declaration the methods used to measure the percentage of drugs ready to be serialized, the calculations used to arrive at the percentage, and the technology employed to meet the pedigree requirements;

Initial Statement of Reasons                                                                                                                           Page 1 of 65.   A requirement for each manufacturer to submit a declaration to the board by December 1, 2015 that includes a list and quantity of dangerous drugs by name and product package (SKU) type representing at least fifty percent of the manufacturer’s drugs that are ready for implementation as of January 1, 2016;
6.  A specification that failure to submit or re‐submit a declaration compliant with subdivisions (a)(1) or (a)(2) of this Section constitutes a violation of the Pharmacy Law;
7.   A requirement for each manufacturer, wholesaler or repackager seeking to designate dangerous drugs it possesses, owns, or controls as “not subject” to pedigree requirements to submit a declaration to the board by August 1, 2016 that includes a list and quantity of dangerous drugs by name and product package (SKU) type acquired prior to July 1, 2016;
8.  A requirement for each manufacturer, wholesaler or repackager to state in the declaration the means and source of acquisition and the anticipated means of any subsequent distribution or disposition;
9.  A requirement for each pharmacy or pharmacy warehouse seeking to designate dangerous drugs it possesses, owns, or controls as “not subject” to pedigree requirements to submit a declaration to the board by August 1, 2017 that includes a list and quantity of dangerous drugs by name and product package (SKU) type acquired prior to July 1, 2017;
10. A requirement for each pharmacy or pharmacy warehouse to state in the declaration the means and source of acquisition and the anticipated means of any subsequent distribution or disposition; and,
11.  A requirement that the board or its designee shall have sole discretion to determine whether declarations submitted pursuant to this Section are compliant and to reject and require re‐submission of any non‐compliant declaration until determined to be fully compliant.
Factual Basis/Rationale/Problem Addressed
Business and Professions Code section 4005 generally authorizes the board to amend rules and regulations necessary for the protection of the public pertaining to the practice of pharmacy and the administration of Chapter 9 of Division 2 of the Business and Professions Code.
In 2004 the California State Board of Pharmacy (the board) sponsored legislation, Senate Bill (SB) 1307, that made comprehensive changes to the drug distribution system to protect against counterfeit drugs. Among other requirements that were enacted, the Pharmacy Law required development of an electronic “pedigree” that tracks each prescription drug (“dangerous drug”) at the saleable unit (item) level through the distribution system. Existing law requires each manufacturer of dangerous drugs, and every wholesaler and pharmacy that possesses dangerous drugs to provide specified notices and declarations to the board by specified dates

Initial Statement of Reasons                                                                                                                           Page 2 of 6for compliance with the electronic pedigree laws. (Business and Professions Code sections4163.2, 4163.5,)  However, the form and content of such notices and declarations are not fully specified. In addition, existing law at Business and Professions Code Section 4034 (operative on January 1, 2015) will require each pedigree to include a “unique identification number.” However, the Pharmacy Law does not specify what that unique identification number must contain to be compliant.
Business and Professions Code section 4034 defines a “pedigree” as a record, in electronic form, containing 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, manufacturers, repackagers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug. This statute specifies that a pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all states of distribution, and specifies the information that shall be included in the pedigree, including the requirement of a linked “unique identification number” for each dangerous drug. The statute becomes operative on January 1, 2015.
The board’s proposal at Title 16, CCR Section 1747 would establish requirements for the “unique identification number” that is to be established and applied to the smallest package or immediate container by the manufacturer or repackager by incorporating by reference the U.S. Food and Drug Administration’s guidance from the following document: “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for PrescriptionDrug Packages,” dated March 2010.  According to the FDA, the guidance document represents the agency's current thinking on standards for drug supply chain security‐standardized numerical identification for prescription drug packages, and was developed after receiving public comment from stakeholders on this issue.
Business and Professions Code Section 4163 specifies dates on which dangerous drugs shall not be sold, traded, or transferred without providing a pedigree, which includes a unique identification number. Accordingly, adoption of Section 1747 in Title 16 of the California Code of Regulations is necessary to enable the Board to provide advance direction to manufacturers and repackagers to begin the process of meeting Section 4163’s mandates.
Business and Professions Code Section 4163.2 provides for the designation of drugs and the submission of written declarations listing those drugs that are not subject to pedigree requirements, as specified (see also Business and Professions Code section 4163.4), and authorizes the board to establish regulations to specify the requirements and procedures for the creation and submission of these written declarations.
Business and Professions Code Section 4163.5 specifies dates by which each manufacturer of a dangerous drug distributed in California shall designate its readiness with the state’s serialized electronic pedigree requirements by providing the board with information representing specified percentages of drugs that are subject to the state’s serialized electronic pedigree requirements, and specifies that each manufacturer shall designate the measure or measures used in designating its drugs to be serialized, according to the process specified by the board.

Initial Statement of Reasons                                                                                                                                        Page 3 of 6The board’s proposal at Title 16, CCR Section 1747.1 would establish dates by which declarations shall be submitted to the board, and the required content of those declarations as it relates to the manufacturer’s readiness to comply with the state’s serialized electronic pedigree requirements.It would also require manufacturers, wholesalers, and repackagers by August 1, 2016 and pharmacies and pharmacy warehouses by August 1, 2017 to submit specified declarations to the board in order to designate dangerous drugs that they possess as “not subject” to the serialized electronic pedigree requirements. The board’s proposal would establish that the board or its designee shall have sole discretion to determine whether any of the declarations submitted are compliant, and authorize the board to reject and require re‐submission of any non‐compliant declaration(s) until determined to be fully compliant. Further, the board’s proposal specifies that failure to submit compliant declarations to the board, as specified, shall constitute a violation of Pharmacy Law. These provisions are necessary to ensure accurate, timely and complete information is being provided to the board prior to making a decision regarding compliance with the electronic pedigree laws. By making non‐compliance with these provisions a violation of the Pharmacy Law, this proposal would also provide the board with a mechanism for enforcing compliance with these reporting obligations.
The “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages,” dated March 2010 is referenced in these amendments. It would be cumbersome, unduly expensive and otherwise impractical to publish the documents in the California Code of Regulations. It is available on the board’s website and fromthe board upon request.

Underlying Data1.    Senate Bill 1307, Chapter 713, Filed with the Secretary of State on September 30, 20082.    “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages,” dated March 2010, U.S. Food and Drug Administration (FDA).3.     Board of Pharmacy “Questions and Answers Relating to the California Electronic Prescription Drug Pedigree Law(s),” January 2008 4.    Letter dated August 25, 2008, by Mark Ridley‐Thomas, Senator, 26th District, Chair of the Senate Committee on Business, Professions & Economic Development to Mr. Gregory Schmidt, Secretary of the Senate5.    The Script (Board of Pharmacy Newsletter), February 2009, “Changes in Pharmacy Law”and “Compliance Dates Extended for e‐Pedigree Requirements” (pp. 1‐6)6.    Board of Pharmacy Comments re: Enhancing Pharmaceutical Distribution Integrity Act of2012, Letter Dated June 17, 2012, Signed by Stan Weisser, RPh, President of the Board ofPharmacy, and by Virginia Herold, Executive Officer of the Board of Pharmacy7.    Relevant Meeting Materials and Minutes from the Board of Pharmacy Board Meeting heldMay 12, 20128.    Relevant Meeting Materials and Minutes from the Board of Pharmacy, EnforcementCommittee and E‐Pedigree Public Meeting held June 12, 2012

Initial Statement of Reasons                                                                                                                           Page 4 of 69.    Relevant Meeting Materials and Minutes from the Board of Pharmacy Board Meeting heldJuly 17‐18, 201210.  Article “What you need to know now about California e‐Pedigree,” Healthcare Packaging, July 20, 2012 (viewed July 24, 2012) http://www.healthcarepackaging.com/archives/2012/07/what_you_need_to_know_now_abou.php11.  “California Staggering Its E‐Pedigree Regulations,” PMPNews.com, Published August 7,2012, on Pharmaceutical & Medical Packaging News (http://www.pmpnews.com)12.  Economic Impact Analysis

Business Impact
The Board does not believe that this regulation will have a significant adverse economic impact on businesses. Representative businesses have a statutory requirement to have a pedigree that includes a unique identification number which is able to be tracked through an interoperable electronic system (see Business and Professions Code Section 4034). Moreover, the U.S. Food and Drug Administration has provided guidance to industry on standardized numerical identification numbers for prescription drug packages. Thus, the Board believes that its proposal would nothave a significant statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states.
The Board’s proposal, however, would impose the following reporting, recordkeeping, or other compliance requirements: manufacturers of dangerous drugs would be required to report by way of declaration to the board by December 31, 2014 regarding its initial implementation of the pedigree laws, and thereafter regarding final implementation by December 31, 2015. Additionally, this proposal would also require manufacturers, wholesalers, and repackagers by August 1, 2016 and pharmacies and pharmacy warehouses by August 1, 2017 to submit specified declarations to the board in order to designate dangerous drugs that they possess as “not subject” to theserialized electronic pedigree requirements. BenefitsBusiness and Professions Code section 4005 states that “the board may adopt rules and regulations….pertaining to the practice of pharmacy….” Further, Business and Professions Code4001.1 states that the “protection of the public shall be the highest priority for the Board in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.” The board believes the regulatory changes as described in the Notice will serve to protect the public health by specifying requirements for the initial phase of compliance with California’s electronic pedigree requirements. Compliance helps ensure that tracking of drug products occurs consistent with the pedigree laws, resulting in the public being better protected from counterfeited and adulterated dangerous drugs entering California’s prescription drug supply chain.

Initial Statement of Reasons                                                                                                                           Page 5 of 6Specific Technologies or Equipment
This regulation would specify the requirements for the “serialized numeric identifier” that would be contained in a pedigree of a dangerous drug, as specified.
Consideration of Alternatives
The Board of Pharmacy has made an initial determination that no reasonable alternative to the regulatory proposal would be either more effective in carrying out the purpose for which the action is proposed or would be as effective or less burdensome to affected private persons and equally effective in achieving the purposes of the regulation in a manner that ensures full compliance with the law being implemented or made specific.
Set forth below are the alternatives which were considered and the reasons each alternative was rejected:
The board is authorized by law to implement, interpret or make specific the laws under its jurisdiction (Business and Professions Code sections 4005, 4163.2(a)(3), 4163.5(b),(c)). With respect to the unique identification number, the FDA’s guidance document represents the agency's current thinking on standards for drug supply chain security‐standardized numerical identification for prescription drug packages, and was developed after receiving public comment from stakeholders on this issue. At numerous meetings conducted by the board regarding the development of the unique identification number standard, industry representatives have indicated that the guidance document’s standards were acceptable methods of creating the unique identification number for serialization purposes. No other alternatives were proffered at these meetings; therefore, no others were considered by the board.
The requirements for reporting by way of declaration, including some of the elements contained within the declaration, are set forth in Business and Professions Code section 4163.2 and 4163.5. As this method was designated by the enabling legislation, no other options were considered by the board. The contents of the declarations were discussed at various meetings on the subject and no other options for content were proffered at those meetings. Consequently, no other alternatives were considered.

Filed under: Uncategorized No Comments
18Sep/120

FDA Approves new MS drug.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new drug for multiple sclerosis.

Sanofi subsidiary Genzyme announced that the FDA had approved Aubagio (teriflunomide) as a once-daily, oral treatment for patients with relapsing MS.

"We are very excited to introduced Aubagio as a new treatment option that can make a difference in the lives of people with multiple sclerosis," Genzyme president and CEO David Meeker said. "The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community."

 

Filed under: FDA No Comments
30Aug/120

Great Future Opportunity for Specialty Pharmacy: Teva gets approval on copy of Neupogen

U.S. drug regulators gave the nod to a Teva Pharmaceutical Industries drug that boosts the production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy. Teva's medicine is in many ways a copy of Amgen Inc's biologic drug Neupogen, which faces the expiration of its U.S. patent next year. In an a settlement of patent litigation, Teva agreed last year to refrain from launching its versions of Neupogen and Neulasta, Amgen's longer-lasting white blood cell booster, in the United States until November 2013.

Filed under: FDA No Comments
19Jul/120

Walgreens and Express Scripts Reach Agreement

WASHINGTON (AP) - Pharmacy chain Walgreens says it will begin filling prescriptions from customers in the Express Scripts network starting in September under a new multiyear contract between the companies.

Walgreen had stopped filling prescriptions for Express Scripts after a contract between the companies ended last year.

Shares of Walgreen Co. jumped 14 percent in premarket tradingwhile Express Scripts shares rose 3 percent.

Express Scripts Holding Co. said it ended the contract with Walgreen because the drugstore operator wanted a premium compared to what Express Scripts paid other pharmacies.

Walgreen Co. has seen sales slump for several months due to the split, but had said it would rather give up the revenue than continue filling unprofitable prescriptions.

The companies said in a statement Thursday that Walgreen will rejoin a network of pharmacies available to Express Scripts customers starting Sept. 15. Terms of the new contract were not disclosed.

(Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)

 

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17Jul/120

FDA Announces New Director of the Office of Generic Drugs

The Office of Pharmaceutical Science (OPS) is pleased to announce the selection of Gregory P. Geba, M.D., M.P.H., as Director of the Office of Generic Drugs (OGD) effective July 15, 2012.

Dr. Geba has served in senior-level clinical/managerial positions in the pharmaceutical industry for the past 15 years. He most recently served as Deputy Chief Medical Officer for Sanofi US, where he provided medical and scientific leadership and managerial direction to a staff of approximately 500 multidisciplinary scientific and regulatory professionals engaged in drug development activities across all therapeutic areas, as well as to the company’s field medical group.

He has contributed to the registration of more than 20 currently marketed drugs or devices across multiple therapeutic areas. In so doing, he successfully employed his working knowledge and demonstrated practical application of drug manufacturing processes, current quality and risk management processes, and standards relevant to FDA’s laws and regulations. He brings extensive clinical research experience, including leading or serving as the key point in filing new drug applications, biologic license applications, and promotional studies comparing efficacy and effectiveness of novel biopharmaceuticals versus standard of care (including regimens containing branded or generic drugs), and has provided or supervised key safety updates and presentations to FDA Advisory Committees. Dr. Geba’s experience also includes leading medical affairs activities while serving in a variety of senior-level positions. His scope of responsibility in those activities included contribution to the design of experimental protocols and assessment of data from pre-clinical, animal, and first-in-human studies; design, implementation, analysis, and interpretation of phase 2a proof-of-concept and 2b dose ranging studies; and production of important comparative effectiveness and safety data when assessing benefit-risk relationships during phase 3, phase 3b, and phase 4 studies.

Dr. Geba received his medical degree from the University of Navarre and his M.P.H. from the Johns Hopkins Bloomberg School of Public Health. He joins OGD at an opportune time to lead our expanding generic program into a reorganization of both structure and process to improve coordination, communication, and efficiency, as well as enhance the Office’s ability to ensure that all generic drugs—which make up nearly 80 percent of prescriptions filled in the United States—are safe, effective, of high quality, and interchangeable with the brand name drug product/reference listed drug.

 

Filed under: FDA No Comments
11Jul/120

President Obama Signs User Fee Bill

On July 9, President Obama signed S. 3187, the Food and Drug Administration Safety and Innovation Act, which reauthorizes FDA user fees for pharmaceutical products. The legislation is the latest reauthorization of the Prescription Drug User Fee Act (PDUFA), which passed the House and Senate last month. Beyond the user fee provisions, the bill also includes new policies to address drug shortages; increases penalties for counterfeiting drugs; provides a directive to establish interoperability standards for prescription drug monitoring programs; as well as includes additional requirements for studies on hydrocodone scheduling, online pharmacies and combating prescription drug abuse by government agencies.

The final package did not include pedigree or traceability standards for pharmaceuticals.