Friday, December 19, 2014
2012 Index Minimize

Report
Number

Description

Date
Issued

337
President Obama Signed Into Law the Safe Doses Act 

28-Nov-12
334
India Finalizes GDP Guidelines for Biological Products 

06-Nov-12
332
New EU Q&A on Falsified Medicines Directive

29-Oct-12
330
US Senate Publishes Draft Proposal to Improve Drug Distribution Security (Track & Trace Propsal) 

25-Oct-12
329
Please Participate in a Rx-360 Survey on EU GMP Part 3 Changes 

19-Oct-12
325
Read the Rx-360 Summary of The Food and Drug Administration Safety and Innovation Act (FDASIA), Title VII

28-Sep-12
324
Read the Rx-360 Summary of the Indian Draft GDP Guidelines for Biological Products

27-Sep-12
319
Read the Rx-360 Summary of EU GMP Revisions to Chapter 7 on Outsourcing

18-Sep-12
310
Rx-360 Summary of Title X of the Food and Drug Administration Safety and Innovation Act Establishes Requirements to Prevent Drug Shortages
 
 
17-July-12
309
EMA Publishes 32 Questions and Answers on the Falsified Medicines Act

12-July-12
307
FDA Warns Two Canadian Pharmacies for Selling Unapproved Drugs

29-Jun-12
305
The FDA has submitted a formal application to start a supply chain security pilot for drug product and API's

26-June-12
304
New ANVISA Draft GMP Requirements for Excipients

18-June-12
303
Time and Temperature Sensitive Label Label to Become Mandatory on 1 July 2012

12-June-12
302
G8 nations met at Camp David on May 18-19, 2012 to collaborate against counterfeit medicines

31-May-12
296
Read the Rx-360 Summary of MHRA's Falsified Medical Products Strategy 2012-2015


17-May-12
295
Read the Rx-360 Summary of The White House's Executive Order -- Promoting International Regulatory Cooperation

16-May-12
293
Rx-360 Summary of the FDA Global Engagement Report

08-May-12
292
Rx-360 Summary of Draft EMA Process Validation Guidance

 
23-Apr-12
N/A
Medicines Control Council of South Africa Publishes Draft Guidance for Distribution of Pharmaceuticals

25-Apr-12
N/A
US FDA Issues SOP on Cargo Theft

25-Apr-12
N/A
IOM Report on Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

25-Apr-12
286


Read the Rx-360 Summary of US House Draft Bill to Prevent Drug Shortages by Amending the FD&C Act 

 

09-Apr-12
285


Read the Rx-360 Summary of API Regulatory Inspection Sharing Programme

 

09-Apr-12  
282
Rx-360 summary of the recently issued FDA Cut Label Fianl Rule 

23-Mar-12
281


Rx-360 Summary of PIC/S Recommended Model for Risk-Based Inspection Planning in the GMP Environment 

 

16-Mar-12
280


Rx-360 Summary of FDA Drug Shortage Guidance  

 

02-Mar-12
279


Read the Rx-360 Summary of the US GAO Supply Chain Security Report

 

28-Feb-12
278


Read the Rx-360 Summary of the Propsoed USP Chapter 1083 Concerning Supply Chain Integrity

 

27-Feb-12
271


Read the Rx-360 Summary of EC Concept Paper for Importing APIs

06-Jan-12
270
Read the Rx-360 Summary of the FDA Interim Final Rule on Product Discontinuance

05-Jan-12
269
Rx-360 Summary of US S-1886 Counterfeit Penalty Act
05-Jan-12

 

  

President Obama Signs Safe Doses Act Minimize
President Obama Signed Into Law the Safe Doses Act

Rx-360 Issued: 28-November-2012
 
President Obama signed into law the Safe Doses Act, bipartisan legislation to fight medical theft and protect patients from unknowingly using stolen and mishandled drugs.

“Before, federal law did nothing to distinguish between stealing a load of insulin or a truck full of tires," Sensenbrenner said. "Now, with the Safe Doses Act, we have given our law enforcement the tools they need to find and prosecute those who endanger countless lives through drug theft.”

“Drug theft is a serious threat to the public and its prevalence is only spreading. Patients rely on life-saving drugs and medical devices. That trust is broken when stolen and mishandled medical products are resold back into the market. This law is a positive, bipartisan step to fighting medical theft by addressing every step in the supply chain. I am happy the President signed this bill into law to protect patients from stolen and mishandled medical products.”

To read HR 4223 one page summary click here

H.R. 4223, the Safe Doses Act:
  • Increases sentences for those who steal medical products.
  • Enhances penalties for the “fences” who knowingly obtain stolen medical products for resale into the supply chain.
  • Increases sentences when harm occurs- where injury or death results from using a stolen substance or where the defendant is employed by an organization in the supply chain.
  • Makes theft of medical products a predicate for the Racketeer Influenced and Corrupt Organizations (RICO) law, to equip law enforcement with needed tools.
  • Increases possible sentences for robbing pharmacies of controlled substances.
  • Provides restitution to victims injured by stolen medical products.
This legislation was introduced in the House by Representative Jim Sensenbrenner (R-WI) and in the Senate by Senator Chuck Schumer (D-NY), and the Senate voted to pass it on September 22, 2012. The House passed the legislation on June 26, 2012.
 

To view or download the legislation, click here

To view or download the Rx-360 Summary of legislation, click here

 
 

 

  

Indian GDPs for Biologics Minimize
Rx-360 Summary of Indian Draft GDPs for Biological products
 

Rx-360 Issued: 06-November-2012

The Central Drugs Standard Control Organization (CDSCO) of India published the final version of Guidelines on Good Distribution Practices for Biological Productswith an effective date of October 8, 2012.  

 

 

A draft version was published for consultation on September 17, 2012 and a summary was published by Rx-360.  The final guideline content appears unchanged from the draft document and thus the Rx-360 September 24, 2012 summary reflects the content of the final document. Overall, the guideline stresses the shared ownership that all members of the supply and distribution chain have in ensuring that biological products retain their quality during all phases of transportation.

 

The scope of the document is  broad and covers storage and distribution activities from the site of manufacture to the point at which product is dispensed or administered to the patient.  Its scope also includes manufacturers of bulk (though it isn’t clear whether this means drug substance or bulk drug product) and finished products.   The draft Guideline addresses activities required for participants in the distribution supply chain, including but not limited to:

  • Organization and Management
  • Quality System
  • Premises Warehouse and Storage (includes requirements for temperature mapping)
  • Temperature, Environment and Storage Control
  • Transportation
  • Documentation

Similar to the EU draft GDP Guidelines, this also states that product is to be stored and transported at “conditions described on the label”.  Specific details are provided in paragraphs 10.1, 11.1 and 11.6.    Paragraph 13.1 states “Validated temperature-control systems…shall be used to ensure that correct transport conditions are maintained between the distributor and customer.” If customers request data demonstrating that the product was maintained within the specified temperature range this should be provided (paragraph 13.2).  Paragraph 4.3 requires that the “principles of GDP”  are met for returned and recalled product.
 

To view or download the finalized guidance document, click here

To view or download the Rx-360 Summary of the guidance, click here

 

 

  

New EU Q&A on Falsified Medicines Directive Minimize

New EU Q&A on Falsified Medicines Directive

Rx-360 Issued: 29-October-2012

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On October 26, 2012 the European Commission published IMPORTATION OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE, QUESTIONS AND ANSWERS, VERSION 2.0”  that supersedes Version 1 of the Q&A published in July 2012.    

This document addresses frequently asked questions on the new rules regarding the importation of active substances for medicinal products for human use described in the Falsified Medicines Directive.  These rules are contained in Articles 46b and 111b of Directive 2001/83/EC.  The 'written confirmation' referenced in the Q&A is addressed in Article 46b(2)(b) of the same directive.  Briefly, shipments of API into the EU must be accompanied by a written confirmation regarding GMP compliance beginning in July 2013. Exceptions to this rule include:  1)  countries have applied for and been determined to meet specific requirements regarding equivalence of the country’s GMPs to the EU GMP Guide and the nature and frequency of GMP inspections of manufacturing sites or 2) have a member state sponsored exemption based on medical need. Currently no country has been granted an exemption although five countries have applied:  Israel, Switzerland, Australia, Singapore and Brazil.  Revision 2 adds questions 18a and 18b and questions 29a and 29b.


To view or download the EU Q&A, click here
.

  

US Senate Publishes Draft Proposal to Improve Drug Distribution Security Minimize

US Senate Publishes Draft Proposal to Improve Drug Distribution Security

Rx-360 Issued: 25-October-2012

 

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The US Senate HELP (Health, Education, Labor and Pensions) Committee released a draft proposal to improve the security of pharmaceuticals through the supply chain, which is part of a continued discussion to establish a uniform, national traceability system to secure the pharmaceutical supply chain.  To read the discussion draft go to:

http://www.harkin.senate.gov/documents/pdf/5088395e6f3ac.pdf

“The track and trace draft proposal is the result of continued, bipartisan, good-faith discussions among a variety of participants,” Senator Bennet said in a statement Wednesday. “While we still have work to do, I am pleased with this progress and believe if we keep working together we can get this done.”
The bill would give the Food and Drug Administration (FDA) authority to work with drug distributors and manufacturers to develop a drug tracking and tracing system.

Please submit your written comments by 6pm on Wednesday, November 7, 2012, to the following:
  • Kathleen Laird (Kathleen_Laird@help.senate.gov) in Senator Harkin’s office
  • Grace Stuntz (Grace_Stuntz@help.senate.gov) in Senator Enzi’s office,
  • Carly McWilliams (Carly.McWilliams@mail.house.gov) in Representative Upton’s office, and
  • Allison Corr (Allison.Corr@mail.house.gov) in Representative Waxman’s office.

 

    

EU Chapter 3 Minimize

Please Participate in a Rx-360 Survey on EU GMP Part 3 Changes

Rx-360 Issued: 19-October-2012

Rx-360 is launching a survey to assess the knowledge and reaction of a broad range of companies to the EU GMP Part 3 changes. All companies (regardless of membership in Rx-360) are invited to respond to this survey. Responses will be blinded and aggregated by the Rx-360 Secretariat.

To view an Rx-360 Memorandum regarding background information on the changes to EU GMP Part 3,
click here.

Please use this link to access the survey by 01-November-12: 
https://www.research.net/s/ZPB2VQK
 

  

Title VII (Drug Supply Chain) of the FDA Safety and Innovation Act Minimize

Rx-360 Summary of The Food and Drug Administration Safety and Innovation Act (FDASIA), Title VII

Rx-360 Issued: 28-September-2012

The Food and Drug Administration Safety and Innovation Act (FDASIA) passed out of Congress on June 26, 2012 and includes Title VII devoted to Supply Chain. While track and trace was not addressed in the FDASIA, there are efforts underway to adopt separate legislation on that topic to forestall a myriad of efforts at the state level.  Another notable absence is that FDA was not given the recall authority that they sought from Congress.  As detailed in the accompanying slide deck, regulations and guidance will need to be adopted in order to implement many of the requirements in this section of the legislation.  Among the most notable new requirements of Title VII are:

  • Removal of the requirement for biennial inspection of drug manufacturing sites and transition to a risk-based inspection frequency

  • GMP now requires “…managing the risk of and establishing the safety of raw materials used in the manufacturing of drugs, and finished drug products.”  Thus, failure to adequately control the supply chain of raw materials that are used in drug manufacture could result in the product being deemed adulterated.

  • FDA must establish good importer practices “that specify the measures an importer shall take to ensure imported drugs are in compliance with the requirements of this Act and the Public Health Service Act.”
     

    To view or download the legislation, click here

    To view or download the Rx-360 Summary of legislation, click here

 

  

Indian GDP Guidelines for Biological Products Minimize

Rx-360 Summary of Indian Draft GDPs for Biological products

Rx-360 Issued: 27-September-2012

The Central Drugs Standards Control Organization (CDSCO) of India posted a draft Guidelines on Good Distribution Practices for Biological Products on their web site on September 17, 2012.  This is available for comment for 15 days after posting.  The scope of the document is  broad and covers storage and distribution activities from the site of manufacture to the point at which product is dispensed or administered to the patient.  Its scope also includes manufacturers of bulk (though it isn’t clear whether this means drug substance or bulk drug product) and finished products.   The draft Guideline addresses activities required for participants in the distribution supply chain, including but not limited to:

  • Organization and Management
  • Quality System
  • Premises Warehouse and Storage (includes requirements for temperature mapping)
  • Temperature, Environment and Storage Control
  • Transportation
  • Documentation

Similar to the EU draft GDP Guidelines, this also states that product is to be stored and transported at “conditions described on the label”.  Specific details are provided in paragraphs 10.1, 11.1 and 11.6.    Paragraph 13.1 states “Validated temperature-control systems…shall be used to ensure that correct transport conditions are maintained between the distributor and customer.” If customers request data demonstrating that the product was maintained within the specified temperature range this should be provided (paragraph 13.2).  Paragraph 4.3 requires that the “principles of GDP”  are met for returned and recalled product.

 

To view or download the draft guidance document, click here

To view or download the Rx-360 Summary of the draft guidance, click here

 

  

EU GMP Revisions to Chapter 7 (Outsourcing) Minimize

EU GMP Revisions to Chapter 7 on Outsourcing

Rx-360 Issued: 18-September-2012

The EMA has published finalized revisions to Chapter 1, Chapter 7 and Annex 2 of the GMP Guidelines.  All three become effective January 31, 2013.  Here we address Chapter 7 because it has direct application to pharmaceutical supply chain activities. The draft Chapter 7 issued for consultation in November, 2010. 

Only minimal changes were made between the draft consultation version and the final version.  The new revised segments of this chapter include:

  • The title has been revised from “Contract Manufacture and Analysis” to “Outsourced Activities” to more accurately reflect the scope of activities;
  • The text is revised to incorporate the principles of ICH Q9 and Q10;
  • Clear statement (7.4) that the Contract Giver has ultimate responsibility for any outsourced activities;
  • Section 7.5 has been modified to add the clause “Prior to outsourcing activities”, the Contract Giver is responsible to assess the capability of the Contract Acceptor;
  • Section 7.7 states that the Contract Giver should “monitor and review” performance of the site to which activities are contracted;
  • Section 7.8 states that the Contract Giver should review and assess the records / results related to the outsourced activities and ensure that materials are processed according to GMPs and the marketing authorization;
  • Section 7.13 addresses the sharing of information regarding the contract site with regulators.  “The Contract Acceptor should understand that outsourced activities, including contract analysis, may be subject to inspection by the competent authorities.”  

To view or download the revised EU GMP Chapter 7, click here

To view or download the Rx-360 Summary of the revisions, click here

 

  

US Law to Address Drug Shortages Minimize

Title X of the Food and Drug Administration Safety and Innovation Act Establishes Requirements to Prevent Drug Shortages


Rx-360 Issued: 17-July-2012

The increase in drug shortages in the past two years has resulted in heightened visibility on this problem.  The US FDA has published guidance and spoken on their activities in this area at a variety of public meetings.  Title X of the Food and Drug Administration Safety and Innovation Act (FDAISA) describes the process by which FDA will address drug shortages in the future.  This legislation formally expands the categories of drugs for which advance notification and reporting is required to include drugs used in “emergency medical care” or during surgery.  The legislation specifies the actions that companies must take in this regard and those that FDA must take in response.  Ideally, this will minimize the number of shortages or at least minimize or mitigate the impact. FDA is also give authority to expedite review of submissions and inspections that can minimize or prevent drug shortages.  Regulatory flexibility is also given to hospitals to repackage a drug for transfer to a hospital within the same system.  The legislation specifies how FDA will report to Congress on this issue and requires them to develop task forces and strategic plans they will put into place to address the larger issue of drug shortages.  FDA-authored reports and other publications have described the complex interplay of factors that result in  drug shortages, and this Title within the FDAISA demonstrates the seriousness with which Congress views this problem.   

To view or download the Act, click here

To view or download the Rx-360 Summaryof the Act, click here

  

Falsified Medicines Directive Minimize

EMA Publishes 32 Questions and Answers on the Falsified Medicines Act

 

Rx-360 Issued: 12-July-2012

The Falsified Medicines Directive passed in July 2011 establishes new requirements to protect against counterfeit medications in the European marketplace.  The requirements   become effective i July 2, 2013.  One of the key elements is set forth in Article 46(b) requiring that active substances shall only be imported into the EU if:

  • they have been “manufactured in accordance with standards of good manufacturing practice at least equivalent to” those of the EU
  • AND they are accompanied by a written confirmation from the competent authority of the exporting country stating:
    • that product is manufactured under the GMP standards equivalent to the EU GMPs
    • The manufacturing plant concerned is subject to regulator, strict and transparent controls and to effective enforcement of GMP including repeated and unannounced inspections and
    • Information on non-compliance is communicated by the exporting country to the EU “without delay”

Exception from these requirements are possible in two situations :

  • Countries that the EU specifically identifies as having adequate GMP standards, or
  • In cases “necessary to ensure the availability of medicinal products…” where a member state has inspected the site and found it to comply with the principles and guidelines of GMP.  The later exception may be effective for the duration of the current GMP certificate. 

Rx-360 published Flash Report  summaries of this legislation on March 15, 2011, and Rx-360 Flash Report #218 on July 5, 2011.  In both instances, the issue regarding new requirements for import of active substances into Europe were highlighted. 

On December 7, 2011, the EC released a concept paper, Implementing Act on the Requirements for the Assessment of the Regulatory Framework Applicable to the Manufacturing of Active Substances of Medicinal Products for Human Use, where they describe how they intend to implement this requirement.  It was released for consultation, with comments due March 23, 2012. For additional detail, please refer to Rx-360 Flash Report #271 published on January 6, 2012.

On April 16, 2012 the EC released a Draft Template for the Written Confirmation for Active Substances Imported into the European Union for consultation that contained proposed information that would be expected from the competent authority of an exporting their country.  Comments on the template were due to EC on May 15, 2012. 

On July 10, 2012, the European Commission issued the template form for “written confirmation” required by Article 46(b).  A copy of the template form can viewed or downloaded by clicking here.   The EMA published a 32-question Q&A document on July 11, 2012 that clarifies the expectations associated with the confirmation requirement, to view or download the Q&A, click here.  The responses to questions 10 and 11 indicate that this confirmation does not apply to active substances contained in imported finished product, nor does it apply to partially manufactured finished product (active plus excipients) imported into the EU.  So far only two countries have applied for exemption to the confirmation requirement -  Israel and Switzerland - and their applications are under review.  No country has been approved at this time.  Unless the US applies for an exemption, an active substance imported into the EU after July 2, 2013 must be accompanied by the confirmation documentation.  

Many of the European Pharmaceutical trade organizations have been active in preparing and submitting comments on the later two documents.  While this issue is well known in Europe, it may not be so well known in countries that supply a large percentage of pharmaceutical active ingredients.  And in those cases where it may be known, it is unclear whether the competent regulatory authorities have the statutory authority and expertise to prepare and submit the requested information.  Manufacturers should work with their API suppliers to ensure they are aware of the requirement and to take efforts to prevent medicinal product shortages when this requirement takes effect.

 

 

  

FDA Warns Two Canadian Pharmacies for Selling Unapproved Drugs Minimize

FDA Warns Two Canadian Pharmacies for Selling Unapproved Drugs

Rx-360 Issued: 29-June-21012

Thomas Christi, Acting Office Director for the FDA's Office of Drug Security, Integrity and Recalls sent warning letters to Pharmawest Pharmacy and Best Price Rx, two Canadian pharmacies known by their websites on May 24, 2012.  To see the FDA Warning Letters click on the following links Best Price Rx Warning Letter and  Northwest Pharmacy Warning Letter.  The warning letters state that the FDA has determined that the companies' websites "offer an unapproved and misbranded new drug for sale in violation" of US law and requests that the companies cease marketing these products to US consumers. 

The FDA's Warning Letters state "FDA is taking action against your firm because of the inherent risk in buying unapproved and misbranded new drugs. Unapproved new drugs may not have the same assurance of safety, efficacy, and quality as drugs subject to FDA oversight, and such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. FDA-regulated drugs offer protections that include rigorous scientific standards for new drug approval, labeling review for accuracy and completeness, and manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public may not be safe and effective."

 

  

FDA looks to start supply chain security program for foreign drugmakers Minimize

 FDA looks to start supply chain security program for foreign drugmakers

Rx-360 Issued: 26-June-2012

The voluntary program was first introduced in 2009 to assist the FDA in preventing the importation of adulterated or unapproved drugs by allowing the agency to focus its resources on imported drugs that fall outside the programme and that may pose such risks.

The aim is to select 100 applicants to participate in the two-year pilot who can demonstrate that they maintain tight control over their products from the time of manufacture through to entry into the US.

After companies are vetted by the FDA's Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA), companies in the pilot would enjoy expedited entry into the US for their drug products or APIs. 

Since the announcement of program, the FDA has received comments about the pilot, which have been published in the Federal Register along with information about how the program.

The FDA has formally asked for approval of the pilot in order to meet federal requirements to estimate the burden on the agency's resources of new initiatives and to double check the information that can legitimately be collected from applicants.

If a green light is given by the Office of Management and Budget (OMB) participants will be invited to take part shortly thereafter.

 

  

Brazil’s ANVISA published a draft Resolution that would require GMP compliance by manufacturers of pharmaceutical excipients Minimize

Brazil’s ANVISA Published a Draft Resolution that Would Require GMPCompliance by Manufacturers of Pharmaceutical Excipients

Rx-360 Issued: 15-June-2012

On May 28, 2012, Brazil’s ANVISA published a draft Resolution that would require GMP compliance by manufacturers of pharmaceutical excipients.  The consultation period of 60 days began seven days after its publication.  The draft GMPs for excipients in this draft act include eight chapters generally reflective of the type of requirements that are applied to human medicinal products and their APIs.  If this Resolution is finalized as written it would require manufacturers of excipients to comply with the following general requirements:

  • General Considerations
    • Excipient manufacturers must hold a working authorization and sanitary license
    • Excipient manufacturers would be subject to inspection by the competent authorities
    • The manufacturer must state and justify at which point GMPs are applied based on the step(s) in the process where the quality of raw materials and intermediates can have “critical influence” on the quality of the excipient
  • Quality Management including specified responsibilities of the Quality unit and requirements for self inspection
  • Personnel: including general hygiene, health exams, GMP training, and prohibitions on the wearing of watches, jewelry and makeup in areas where product is exposed
  • Buildings and Facilities
  • Prohibition of the manufacture of highly toxic non-pharmaceutical ingredients in the same facilities or equipment as excipients
    • Cleaning and sanitization of equipment, cleaning of facilities and pest control expectations
    • Disposal of waste materials
  • Equipment
  • Documentation and Records
  • Materials Control including sampling, testing, reuse and rework, solvent recovery, and prohibition against blending to meet quality standards
  • Production including expectations regarding water quality
  • Packaging, Labeling and Dispatch including specific information that must be on the label
  • Quality Control for raw materials, in process streams, final excipient, retention samples, control of impurities and stability evaluation to support retest or expiry dating
  • Change Control
  • Complaints Recalls and Returns
  • The draft states that while the Resolution will take effect on the date of its publication, existing establishments will have 12 months to fully comply.  New facilities must fully comply immediately and are not provided with the 12 month grace period.

To view or download the ANVISA Draft Resolution, click here

To view or download the Rx-360 Summary of the Draft Resolution, click here

 

  

TIME AND TEMPERATURE SENSITIVE LABEL TO BECOME MANDATORY 1 JULY 2012 Minimize

Time and Temperature Sensitive Label to Become Mandatory
1-July-2012

Rx-360 Issued: 31-May-2012

Cold chain management provides a particular challenge to the pharmaceutical industry.  Recent changes to the International Air Transport Association (IATA) Perishable Cargo regulations provide for a common label to be affixed to “time and temperature sensitive healthcare cargo shipments”.  The communication indicates that labels are required effective July 1, 2012 for transportation of healthcare cargo shipments.  Included here are the communication which reportedly was sent to customers by IATA, as well as a Q&A publication from IATA.  The Q&A provides a link where the labels may be purchased.  The need for a uniform label was based on the variable labeling provided by each company that ships healthcare cargo.  While each label may be adequate, the many different labels from many companies provides confusion to those who handle these products and provides opportunity for inadvertent mis-management of cold chain items. 

The Perishable Cargo regulations may be purchased from the IATA web site.

To read / or download the regulation, click here

To read / or download the frequently asked questions associated with regulation, click here

  

G8 Summit and Declaration on Counterfeit Medicines Minimize


G8 nations (Canada, France, Germany, Italy, Japan, Russia, UK and US)
met at Camp David in Maryland, US, on May 18-19, 2012

Rx-360 Issued: 31-may-2012

The recent G8 summit at Camp David in Maryland saw the participant nations agree to collaborate against counterfeit medicines. The world leaders said they would exchange information on rogue Internet pharmacy sites and share best practices on combating counterfeit medical products. 

Last year, PSI (Pharmaceutical Security Institute) reported 1,986 counterfeiting cases, down from 2,054 a year earlier but around double the number reported in 2004-2005.

To view or download the Declaration, click here

  

MHRA Falsified Medical Products Strategy 2012-2015 Minimize


Rx-360 Summary of MHRA's Falsified Medical
Products Strategy 2012-2015

Rx-360 Issued: 17-May-2012

MHRA recently published a 41-page report describing how they are combating counterfeit medicines and actions they are taking between 2012 and 2015.  The report is titled Falsified Medical Products Strategy 2012-2015.  MHRA stresses the threat that counterfeit medicines pose to public health and safety.  The article also describes the “lifecycle” of a counterfeit medical product.  The purpose of their actions are to reduce the risk to patients in the UK from the dangers of counterfeit medicines and to increase the risk to those to who participate in counterfeiting activities.  They describe in detail their three-pronged approach that includes:

  • Implementing controls to prevent counterfeit medicines from reaching patients.
  • Management of reported events to ensure adequate and appropriate investigations, supported by recall of product when appropriate.
  • Adequately investigate and use all legislative powers to prosecute the individual(s) involved in counterfeiting activities including their manufacture and distribution.

To view or download the MHRA report, click here

To view or download the the Rx-360 Summary of the report, click here


  

The White House has issued Executive Order -- Promoting International Regulatory Cooperation Minimize

Rx-360 Summary of The White House's Executive Order -- Promoting International Regulatory Cooperation

Rx-360m Issued: 16-May-2012

FDA has clearly stated their intent to actively engage with global regulatory authorities regarding the product types that they oversee.  The major regulatory authorities are levering their resources and are focused on their risk-based application.  To further support this effort the White House published an executive order titled Promoting International Regulatory Cooperation.  The goal of this order is to implement actions to harmonize where possible, or eliminate where appropriate, regulations or requirements that hinder US businesses from exporting their products and competing on an international basis.  A group known as the Regulatory Working Group formed as a result of Executive Order 12866 in September 1993 and further reinforced by an executive order issued in January 2011  “…shall serve as a forum to discuss, coordinate, and develop a common understanding among agencies of the U.S. Government positions and priorities with respect to”:

  • "International regulatory cooperation activities that are reasonably anticipated to lead to significant regulatory actions,
  • Efforts across the Federal Government to support significant, cross-cutting international regulatory cooperation activities such as the work of regulatory cooperation councils, and
  • The promotion of good regulatory practices internationally , as well as the promotion of US regulatory approaches, as appropriate…”

The overall intent seems to include elimination of those regulations and practices that do not add value but that limit our ability to trade on an international basis. It would also include harmonization of requirements where feasible.  This appears to include many product types, and is not limited to medical products.  

 

To view or download the Executive Order, click here

To view or download the the Rx-360 Summary of the
Executive Order, 
click here

  

Rx-360 Shared Audit Programs Minimize

Rx-360 Releases Audit Program Documents and
Available Audit Reports

Rx-360 has two audit sharing programs 1) Joint Audits and 2) Shared Audits. 


Joint Audit Program: 

An Rx-360 biopharmaceutical member or members would request an audit of a supplier's site.  Rx-360 then contracts with a qualified auditor to conduct the supplier audit.

An Rx-360 joint audit can benefit both the Rx-360 member companies who requested the audit and the audited supplier. The benefits include:

  • Reducing the number of pharmaceutical audits at a supplier site while increasing the effectiveness of the audits performed.
  • The Consortium’s third party auditors will utilize a standardized audit approach and use a standard audit report format.
  • Only the most qualified third party auditors will be utilized, ensuring that the audit is effective, efficient and audit standards are applied consistently across suppliers.
  • Rx-360 member companies can reduce the number of audits they perform by utilizing this joint auditing approach.

The audits are added to a secure electronic database.  Reports/responses can be purchased by other interested companies (as agreed to with the supplier and audit sponsor).


The Shared Audit Program: 


Audit Sharing provides many benefits including: 

  • Shared audits provide a broader “picture” of Quality Culture and performance of a supplier
  • Existing reports can be used to identify and pre-screen new suppliers
  • Potential savings with evaluation of reports/responses to reduce supplier audit frequency/length, or audit scope

In the Audit Sharing Program, Rx-360 member audit reports (and associated audit responses from the suppliers) can be uploaded into a secure database with agreement from the supplier.  The audit reports/responses can then be accessed by member companies (as agreed to with the supplier).  This sharing of information can provide pharmaceutical manufacturers with on-going information about specific suppliers of interest, while providing suppliers with visibility to potential customers and the possibility, over time, of reduced pre-audit paperwork, and frequency and/or length of audits.

Rx-360 has posted numerous documents that support the Joint and Shared Audit Program as follows:


1.  Power Point Slide Deck Providing a Description of Joint Audit Program


2.   Rx-360 Joint Audit Program Auditor Qualification 

 

3.   Rx-360 Letter to Suppliers Explaining the Joint Audit Program 

 

 

4.   Rx-360 Joint Audit Program Frequently Asked Questions 
 


5.  
Power Point Slide Deck Providing a Description of Audit Sharing Program


6.  
Rx-360 Audit Sharing Process Flow Chart


7.  Rx-360 Audit Sharing Redaction Policy and Procedure


8.  
Rx-360 Audit Sharing Frequently Asked Questions


9. 
  Rx-360 Supply Chain Security Checklist for Auditors  
 

10.
Rx-360 Audit Guide for Basic Chemicals and Raw Materials   


11.
Rx-360 Audit Guide for Pharmaceutical Chromatography Resins  
 

12.
Rx-360 Audit Guide for Pharmaceutical Excipients  
 

13. Rx-360 Audit Guide for Active Pharmaceutical Ingredients (APIs) and API Intermediates


14. Rx-360 Audit Guide for Pharmaceutical Packaging Materials


15. Rx-360 Audit Reports Availalble for Purchase



 

 

  

FDA Global Engagement Report Minimize

Rx-360 Issued: 08-May-2012

The FDA recently published a report titled Global Engagement that details their change from a primarily domestic regulatory authority to one operating within the global arena.  The report addresses the state of the global market for the products that FDA regulates including food and medical products.   It  includes a series of graphical representation of the globalization of the products that FDA regulates and how that has changed in the past 10 years.  Most importantly, FDA will collaborate with their global regulatory partners and together they will leverage inspection resources in a risk-based manner.  FDA is also expanding their foreign presence with offices in a selected regions to both partner with regulators in those areas and provide a local base for inspection activities.   Some of the topics covered in the report include:

  • Global strategies
  • International offices
  • Harmonizing standards
  • Leveraging resources
  • Risk based inspections
  • Global Surveillance and preparedness including emergency response
  • Advancing regulatory science.

 

To view or download the FDA Global Engagement Report, click here

To view or download the the Rx-360 Summary of the FDA Global Engagement Report, click here

  

Institute of Medicine (IOM) recently published a 300-plus page report titled Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Minimize

IOM Report on Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Rx-360 Issued: 25-April-2012

The Institute of Medicine of the National Academies (IOM) recently published a 300-plus page report titled Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad.  A copy of the Report can be accessed by clicking here.  The report addresses the safety of both food and pharmaceuticals imported into the United States for which FDA provides oversight.  The report acknowledges the budget limitations under which FDA operates and agrees that this limits the direct actions they may take in specific areas. The activities that FDA has already initiated are also addressed.  The Report identifies short-term and longer term actions that FDA might take in leveraging their reach into developing jurisdictions in the areas of food and pharmaceuticals; these may be found in more detail in sections 5 and 6.  The Report concludes that the best way for FDA to leverage their activities in these areas is to work collaboratively with regulators and others in developing countries.  Further, the Report suggests that FDA work with academic institutions in the US, and other mature regulatory bodies throughout the world to better protect the supply chain for food and drugs entering the Unites States. The Report devotes several paragraphs on page 150 to the efforts of Rx-360 in leveraging cooperation within the industry to assist in securing the supply chain for pharmaceuticals.  The IOM recommends  several short-term activities that could be completed in 3-5 years.  These include:

  • Work toward mutual recognition of inspections among the following group of countries:  US, EU, Canada, Japan, Norway, Iceland, Switzerland, Australia and New Zealand. (see recommendation 5-3)
  • Work with other US agencies to strengthen surveillance efforts in developing countries.  This includes pharmacovigilence efforts as well as monitoring of food-borne illnesses. (see recommendation 5-5)
  • International training, selection and staffing of offices and overall international programs should be risk-based. (see recommendation 6-1).
  • FDA should move to a paperless system after implementing appropriate IT systems.  They should also work with their collaborators outside the US to develop a consistent use of terminology. (see recommendation 6-2)
  • Work with universities and other appropriate organizations to assist in training regulators in developing countries.  Ensure that FDA staff are aware of the “international ramifications” of compliance with US regulations.  (see recommendation 6-3).
  • Lead development and adoption of international food and medical product standards.  The report acknowledges FDA’s leadership in this area but notes that “American adoption of harmonized standards leaves something to be desired.”  (see recommendation 6-4)
  • Consider expansion of the “one-up, one-back” traceability requirements required for food to medical products. (see recommendation 6-5)
  • Work to identify and implement “frugal technologies” for “fraud prevention, supply chain management, tracking and verification” that would be implementable with minimal burden in developing countries. (see recommendation 6-6)
  • Evaluate the outcomes and lessons learned from the existing Secure Supply Chain Pilot program with a plan to scale up the program. (see recommendation 6-7)
  

EMA has issued its draft Guideline on Process Minimize

EMA has issued its draft Guideline on Process Validation

Rx-360 Issued: 26-April-2012

The EMA has issued its draft Guideline on Process Validation for consultation.  It will replace the Note for Guidance on Process Validation when it is finalized.  Comments are due to EMA on 31 October 2012.  This communication is not intended to provide a detailed analysis but highlights some high-level areas of similarity and difference  between the EMA's Guidance and the FDA Process Validation Guidance.

 

SIMILARITIES between the guidances: 

  • Both include human and veterinary products
  • Both identify a lifecycle approach to validation
  • Both address traditional process validation and continuous process verification and use of a hybrid approach
  • Some aspects of process validation may be addressed at reduced scale from commercial production

DIFFERENCES between the guidances:

 

  • The EMA guidance scope includes only drug product though it indicates that similar principles may apply to active  substance.  The EMA guidance indicates that for biological products, the principles may apply but will be considered on a case-by-case basis (lines 63-66). The FDA guidance includes drug product, active substance, and biological products within scope.
  • The EMA guidance identifies standard vs. non-standard methods of manufacture for which the validation requirement and submission requirements may be different.  Biological products (lines 115-117) and aseptic processing (lines 121-123) both appear to generally require full scale validation at the commercial site supported by a minimum number of three batches for which information is provided in the MAA.  The guidance does indicate there may be some flexibility, on a case by case basis, depending on the experience and expertise of the manufacturer with the given technology.
  • Relative to the timing of process validation the intent seems similar but the language is different:
    • The EMA guidance states that “…the manufacturing process should be validated before the product is placed on the market.  In exceptional circumstances, concurrent validation may be accepted.” (line 75-76)
    • The FDA guidance states that “Before any batch from the process is commercially distributed for use by consumers, a manufacturer should have gained a high degree of assurance in the performance of the manufacturing process…” (section II.B.)
  • The definition of process validation differs somewhat between the two guidances:
    • EMA definition of Process Validation:  “The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to product a medicinal product meeting it’s predetermined specifications and quality attributes.”
    • FDA definition of Process Validation:  “The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
  • The FDA guidance places significant emphasis on use of statistical analysis, while this is not as much an area of focus in the EMA guidance.  

 To download / view the draft EU Process Validation Guidance, click here

  

Medicines Control Council of South Africa Publishes Draft Guidance for Distribution of Pharmaceuticals Minimize

Medicines Control Council of South Africa Publishes Draft Guidance for Distribution of Pharmaceuticals

Rx-360 Issues: 25-April-2012

The Medicines Control Council of South Africa has published draft guidelines for the distribution of human and veterinary pharmaceutical products in South Africa.  The title of the guideline is “Good Wholesaling Practice for Wholesalers, Distributors and Bonded Warehouses.”  Comments were due to the authorities at the end of March 2012 and a final version is due to be implemented in July 2012.  It includes a discussion of the legislative authority supporting this guideline, the need for Quality Agreements among the various parties, and the importance of customer and vendor verification.  The document is divided into a variety of broad categories with additional detail on each, some of these include: 

  • Personnel, including pharmacists and their support personnel
  • Quality Management Systems including CAPA, validation, calibration electronic records and change control
  • Documentation and Recordkeeping including SOPs, site master files, and legal records including those for specially scheduled drugs
  • Warehouse premises including monitoring of storage conditions and conditions for cold chain products
  • Transportation is addressed both in terms of equipment, vehicles and shipment containers
  • Other topics include complaints, recalls, returned good, counterfeit products and import/export 

 To download / view the draft South Africa Draft Distribution Guidacne, click here

  

FDA SOP on Cargo Theft Minimize

US FDA SOP on Cargo Theft

Rx-360 Issued: 25-April-2012:

FDA published an SOP (SMG9002.1) describing their response to cargo thefts.  This is a new SOP, rather than a revision to an existing procedure and has an effective date of March 23, 2012.  FDA is concerned about cargo thefts for two reasons.  The stolen products may re-enter the legitimate distribution chain at some point and their strength / potency may be compromised if products are not held under appropriate environmental conditions. The SOP describes the roles and responsibilities of the Offices, Divisions and Centers that have a role in these events.  The Office of Criminal Investigations (OCI) takes the lead and will contact the impacted company to verify the theft and will share information with other local, state and federal law enforcement agencies. The participants in the theft response team  are  identified, along with their acronyms, in Appendix A.  The OCI will solicit the following information from the company: 

  • Location of the theft
  • Identity of stolen product including name, strength, dosage form, lot number, expiry date, NDC code and a description of the package
  • Quantity stolen, and quantity of lots of the same products in legitimate distribution
  • Storage requirements for the product(s)
  • Company contact person

According to the SOP, “If the Cargo Theft Response Team (CTRT) determines that an FDA Consumer Alert or other type of notice is necessary (e.g. the firm refuses to notify the public of the cargo theft or the firm issues a press release that does not adequately inform the public about the public health risks associated with using the stolen product), the CTRT will work with the press office in the Office of Public Affairs (OPA) and the appropriate Center(s) to draft a press release and to obtain the necessary clearance from the agency and the Department of Health and Human Services (HHS). Public notification directed to practitioners and institutions will also be considered.”  Thus, if the FDA determines that the company is not providing adequate warning to the public about stolen drugs, FDA will assume the responsibility to communicate the information.

To download / view the US FDA SOP, click here  

 To download / view the Rx-360 Summary of the FDA SOP, 
click here

To download / view the Rx-360 Supply Chain Security
White Paper on Cargo Theft Risk Assessment,
click here

  

US House Drafts Bill to Address Drug Shortages by Amending Food Drug and Cosmetic Act Minimize

Rx-360 Summary of US House of Representatives Draft Bill to Prevent Drug Shortages by Amending the Food, Drug and Cosmetic Act

 

Rx-360 Issued: 09-April-2012

Several proposals have been introduced in the US Congress over the past year addressing issues related to the increasing problem of drug shortages.  None of the proposals have been formally adopted.  FDA has also recently issued a final directed rule expanding the existing reporting requirements for companies that anticipate possible drug shortages and have written draft guidance on the same topic that is out for consultation by industry and other stakeholders.  One of the proposals suggests several changes to the existing Food, Drug and Cosmetic Act, including:  Title IX -“Drug Shortages”.  This proposal specifies the need for industry to report anticipated drug shortages of certain categories of drugs that are “life-supporting; life-sustaining; or intended for use in the prevention of a debilitating disease or condition.”  FDA is also given authority to expedite the review of applications or supplements that may prevent or minimize the impact of a drug shortage.  A firm must meet certain criteria to achieve this expedited 60-day review and approval, including instituting a plan and adequate resources to achieve full GMP compliance and having adequate controls in place until the plan can be fully implemented.

 

To download / view the US House of Representatives Draft Bill, click here  


 To download / view the Rx-360 Summary of the  Draft,  
click here

 


 Rx-360 Summary of US FDA draft Guidance for Industry, Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage

 

Rx-360 Issued: 02-March-2012

FDA published a draft Guidance for Industry, Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage on February 21, 2012. This guidance is issued to assist with implementation of the interim final rule on the same topic published December 19, 2011.   The interim final rule amended the postmarketing reporting requirements, specifically those in 21 CFR 314.81.(b)(3)(iii) published as final on October 18, 2007. Changes address the need to notify FDA in advance when a sole manufacturer plans to discontinue manufacture of a “life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition”.  
 
The interim final rule supports the Executive Order 13588 from October 31, 2011 that directs FDA to “take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines…one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible”.  The intent of these changes is to provide FDA assistance in the management of the dramatic increase in drug shortages. 

 

To download / view the FDA Draft Guidance, click here  

 To download / view the Rx-360 Summary of the FDA Draft, 
click here

  

Programme to rationalise international GMP inspections of active pharmaceutical ingredients/active substances manufacturers Minimize

Rx-360 Summary of Programme to rationalise international GMP inspections of active pharmaceutical ingredients/active substances manufacturers 

Rx-360 Issues: 09-April-2012

The European Medicines Agency (EMA), Australian Government Department of Health and Aging Therapeutic Goods Administration (TGA), and the U.S. Food and Drug Administration (FDA) have ongoing programs to harmonize their international inspections of API manufacturers with the intent to ultimately rely on each others’ inspection results.  The World Health Organization has recently joined this effort in their pre-qualification program for specific drugs and vaccines. This collaborative effort serves to leverage the limited number of inspectors in each agency and the international locations of API manufacture outside of the FDA/EMA/TGA domestic jurisdictions.   The EMA recently published requirements for new regulatory agency participants, along with principles and procedures for conduct of joint, collaborative audits as well as the authorities’ reliance on each others’ audits and audit reports.  Section 4,  (“Procedure”)  specifies the roles, responsibilities and requirements for planning a collaboratively conducted inspection and one where one authority relies on an inspection conducted by another authority.  It addresses issues of planning and communication prior to the conduct of audits, responsibilities of the “lead” inspector, as well as the expectation for separate audit reports when inspections are collaboratively conducted by more than one agency.  This publication reflects ongoing collaboration between major regulatory authorities to leverage their inspectorate resources and reflects implementation of lessons learned in earlier inspections they have conducted together.  

 

To download / view the EMA's description of the programme, click here  

 To download / view the Rx-360 Summary of the programme, 
click here 

  

FDA issued a final rule amending 21 CFR 211.122(g), the rule and controls for use of cut labeling Minimize

FDA Cut Label Final Rule

Rx-360 Issued: 23-March-2012

FDA issued a final rule amending 21 CFR 211.122(g), the rule and controls for use of cut labeling on March 20, 2012.  The previous final rule was dated August 1993 and the proposed rule for this amendment was published on July 29, 1997. The labeling and packaging provisions of 211 was amended in 1993 based on FDA’s analysis that mix-ups in labeling was a significant cause of incorrect drug product labeling and recalls.  The 1993 requirements in 21 CFR 211.122(g) provide for three options for controls where cut labeling is used.  This final rule narrows the scope of 211.122(g) to cover only “cut labeling used for immediate container labels, individual unit cartons or multiunit carbons containing immediate containers that are not packaged in individual unit cartons"  and expands the acceptable control procedures from three to four options.  This rule finalized the 1997 proposed rule without change. The final rule is effective March 20, 2013, except for 211.122(g)(4), that is effective April 19, 2012.  FDA states that providing a fourth option for control of this labeling is meant to “…provide manufacturers with the widest possible latitude in selecting appropriate labeling control technologies.”  As required for final rule changes, FDA addresses each of the comments received on the proposed rule. 

To read or download the FDA's Final Rule, click here

  

PICs: A Recommended Model for Risk-Based Inspection Planning in the GMP Environment Minimize

Rx-360 Summary of PIC/S published “A Recommended Model for Risk-Based Inspection Planning in the GMP Environment”

Rx-360 Issued: 16-March-2012

PIC/S published “A Recommended Model for Risk-Based Inspection Planning in the GMP Environment”, that was effective January 1, 2012.  This is meant to be used by the inspectorates as they implement a risk based approach to assignment of GMP inspections intervals for manufacturing sites.  Many of the criteria are familiar and they provide example scoring and tabulation of results that might perhaps be of interest to firm’s internal audit groups that conduct similar activities. The section focused on intrinsic risk addresses both site and process complexity, thus not all API sites are considered to be equal under this type of analysis.  Criteria to be considered when evaluating site complexity include the size of the site, number of employees, number of products, the extent of shared equipment and facilities among different products and whether the site in includes contract manufacture.  Criteria to be considered when evaluating process complexity includes evaluation of the kind of processes where aseptic manufacturing is always considered highly complex according to this document, number of products, number of steps in the manufacturing process, type of products or dosage forms manufactured.

Inspectors are also instructed to consider a change in number of personnel at a site as part of inspection planning.  An increase in the number of staff might indicate additional products and thus added complexity.  On the other hand, a decrease in the number of staff might suggest “…that there are fewer QA resources available at the site which could lead to compliance problems later on.”

 

To download / view the PICs Model, click here  

 To download / view the Rx-360 Summary of the PICs Model,
click here

  

Guidance for Industry, Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage Minimize

 Rx-360 Summary of US FDA draft Guidance for Industry, Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage

 

Rx-360 Issued: 02-March-2012

FDA published a draft Guidance for Industry, Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage on February 21, 2012. This guidance is issued to assist with implementation of the interim final rule on the same topic published December 19, 2011.   The interim final rule amended the postmarketing reporting requirements, specifically those in 21 CFR 314.81.(b)(3)(iii) published as final on October 18, 2007. Changes address the need to notify FDA in advance when a sole manufacturer plans to discontinue manufacture of a “life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition”. 
 
The interim final rule supports the Executive Order 13588 from October 31, 2011 that directs FDA to “take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines…one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible”.  The intent of these changes is to provide FDA assistance in the management of the dramatic increase in drug shortages. 

 

To download / view the FDA Draft Guidance, click here  

 To download / view the Rx-360 Summary of the FDA Draft,
click here

 

 

 

  

GAO Supply Chain Security Report – February 2012 Minimize

 Rx-360 Summary of the GAO
Supply Chain Security Report – February 2012

Rx-360 Issued: 28-February-2012

The document “Supply Chain Security” is a report by the U.S. Government Accountability Office (GAO) that provides an update and summary of the US Governments efforts to comply with the Maritime Transportation Security Act (MTSA) of 2002.  The MTSA requires that the Department of Homeland Security (DHS) and the US Customs and Border Protection (CBP) agencies develop a strategy to enact a 100% inspection of all cargo containers entering the United States.  What the GAO found was that while DHS and CBP have made progress in enacting strategies such as Customs-Trade Partnership Against Terrorism (CTPAT), Container Security Initiative (CSI), and the development of improved container security technologies, the feasibility of meeting the 100% cargo container inspection requirement by the deadline of July 2012 is not possible.  Therefore, DHS is expected to request of the US Congress, by May 2012, a blanket extension of the program so that further studies and analysis may be completed.


Some of the issues encountered by DHS and CBP include but not limited to: 

 

1. A miscalculation of the cost involved with implementing scanning and radiological detection equipment in high volume ports.  Part of the issue is that the Secure Freight Initiative (SFI) did not specify who (which countries) would be responsible for paying for the infrastructure upgrades.

 

2. While members of the World Customs Organization (WCO) (177 Member Countries) have adopted and embraced CBP strategies that identify and assign an overall risk score to containers based upon specified criteria (e.g., 10+2 data), they are reluctant to implement both 10+2 pre-screening and 100%  scanning of cargo containers.  The prevailing sentiment is that the two strategies are in opposition to one another (i.e., Why identify high risk shipments and then perform 100% scanning?).  The CBP and DHS are also now looking at whether 100% scanning is necessary or even feasible given strategies such as 10+2.  

- 10+2 rule involves collection of 10 data elements from importers, such as country of origin, and 2 data elements from vessel carriers, such as the containers position on the vessel, to assign an overall risk level for the container.

 

3. WCO members, that have high volume container operations (e.g., Hong Kong), that were conducting testing to determine the feasibility of 100% scanning, have since stopped the testing after determining that is was not realistically possible to perform 100% scanning without severe repercussion to its operations, customers and global trade as a whole.

 

4. A CBP study has concluded that existing container seals do not provide adequate security against intrusion.  However, CBP has not thoroughly developed or tested technology that can monitor containers for intrusion.  This is another area in which members of the trade industry are hesitant to implement additional technology given the number of programs that they are currently involved in and must comply with.

 

In conclusion, it appears that DHS and CBP will indeed request a 2 year extension on the  implementation of the 100% scanning requirement of the MTSA.  Additionally, it is highly probable that both the DHS and CBP will attempt to modify the MTSA so that a risk based approach for cargo container screening selection is adopted.  This should, for those 10,000+ companies that are currently certified through programs such as CTPAT, provide additional assurance that their operations/imports will suffer minimal disruption as the US government enforces the requirements set forth in the MTSA.

 

 To view or download the GAO Report, click here

 

  

USP is proposing a new general information chapter on good distribution practices for supply chain integrity <1083> Minimize

USP is proposing a new general information chapter on good
distribution practices for supply chain integrity <1083>

Rx-360 Issued: 27-February-2012

The USP/NF does not currently have a general information chapter on Good Distribution Practices.  This represents the draft document, <1083> Good Distribution Practices --- Supply Chain Integrity.  The globalization of all aspects of the pharmaceutical business has driven the need to address the threats of counterfeit or adulterated medication, devices and components, for which there have been several high profile examples over the last few years.  This chapter addresses the multiple areas of drugs, devices, re-packagers, and internet pharmacies including drug diversion and represents another effort to assist manufacturers and other members of the distribution chain in securing the medical product and device supply chain.  The requirements in general chapters are non-binding but are intended to provide best practices and practical suggestions relative to this topic.  APIs, excipients, drug products and devices are within the scope of this document. 

The USP will host an upcoming 2012Supply Chain Integrity workshop on May 22-23, in Rockville, MD.   More information and a preliminary agenda are posted here:

http://www.usp.org/meetings-courses/workshops/supply-chain-integrity-workshop

The proposed new USP General Chapter <1083> Good Distribution Practices—Supply Chain Integrity will be an important part of the workshop agenda. 

 

To download / view the proposed USP Chapter, click here  

 

To download / view the Rx-360 Summary of the proposed USP Chapter, click here

  

Implementing Act on the Requirements for the Assessment of the Regulatory Framework Applicable to the Manufacturing of Active Substances of Medicinal Products for Human Use Minimize

Implementing Act on the Requirements for the Assessment of the Regulatory Framework Applicable to the Manufacturing of Active Substances of Medicinal Products for Human Use

Rx-360 Issued: 06-January-2012

The European Commission Health and Consumer Directorate-General has released a concept paper titled Implementing Act on the Requirements for the Assessment of the Regulatory Framework Applicable to the Manufacturing of Active Substances of Medicinal Products for Human Use.  This concept paper seeks input on a requirement in the newly approved Falsified Medicines Directive regarding the “regulatory framework applicable to active substances and the respective control and enforcement activities in the third country…”.  Comments are due March 23, 2012 and the adoption of the finalized implementing act is scheduled for July  2013 The EC is now required to develop and maintain a list of countries for which GMP regulatory and enforcement activities associated with manufacture of APIs is equivalent to that in the European Union as part of the Falsified Medicines Directive.  The determination of GMP and enforcement equivalence is proposed to take into account:

 

  • The country’s rules for good manufacturing practice (GMP)
  • The regularity of inspections to verify compliance with GMP
  • The effectiveness of enforcement of GMP
  • The regularity and rapidity of information provided by the third country relating to non-compliant producers of active substances

The concept paper indicates that in performing this assessment the EC will take into account existing Mutual Recognition Agreements, country alignment and acceptance of relevant ICH guidances and existing programs such as the joint inspection programs recently conducted by TGA/FDA/EMA. 

To view or download the EC Concept Paper, click here

To view or download the Rx-360 Summary, click here
 

  

Revision of Postmarketing Reporting Requirements-Discontinuance (published December 19, 2011) Minimize

Revision of Postmarketing Reporting Requirements-Discontinuance (published December 19, 2011)


Rx-360 Issued: 05-January-2012

On 19 December 2011, FDA published an interim final rule published regarding amending postmarketing reporting requirements, specifically those in 21 CFR 314.81.(b)(3)(iii).  The interim rule becomes effective January 18, 2012.  The rule being amended was published on October 18, 2007. The rule addresses the need to notify FDA in advance when a sole manufacturer plans to discontinue manufacture of a life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition”.  This interim rule references both the final rule and its preamble. The interim final rule supports the Executive Order 13588 from October 31, 2011 that directs FDA to “take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines…one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible”.  The changes put forth in this document add two definitions to the existing rule, one for “discontinuance” and one for “sole manufacturer.  The intent of these changes is to provide FDA assistance in the management of the dramatic increase in drug shortages.  The definition of “discontinuance” has been expanded to include “…both temporary and permanent interruptions in manufacturing, if the interruption could lead to a disruption in supply of the product”.  The Federal Register announcement includes examples of situations that would trigger such a notification as well as those instances where no notification would be necessary.  The definition of “sole manufacturer” is clarified to mean “…the only applicant currently supplying the U.S. market with the drug products.”  It does not mean the sole NDA/ANDA holder. 

To view or download the Interim Final Rule, click here

To view or download the Rx-360 Summary, click here
 

 

  

Rx-360 Launches Supply Chain Security Initiative Minimize

 

Rx-360 Releases White Paper on Supply Chain Security Management Systems: A Comprehensive Supply Chain Security Management System

In the fourth Quarter of 2011, Rx360 kicked off a supply chain security (SCS) initiative with the goal of developing and sharing best practices to enhance the integrity of our supply chains and increase patient safety.  This initiative is looking at Supply Chain Security holistically – which means working on processes to prevent, detect, and respond to the threats of theft, diversion, counterfeiting, and intentional adulteration across the entire supply chain (from raw materials to patients).  According to Tim Valko, Co-Leader of the Rx-360 Supply Chain Security Initiative and Amgen's Executive Director of Risk Management "in its short existence, the Rx360 SCS working group has demonstrated the benefit industry collaboration can provide. The working group concept of forming small and nimble limited duration teams focused on specific problems, with participants sharing and exchanging ideas to address them, has been a success." For example, the SCS Working Group only took 4 weeks to develop the Rx-360 White Paper on Supply Chain Security Management Systems.

The white paper on Supply Chain Security Management Systems is now available and can be accessed on the Rx-360 website by clicking here.  The purpose of the paper is to describe the concept of a comprehensive supply chain security management system that provides a foundation for a maturity model that can drive measurable and sustainable improvement of supply chain security practices.  

This paper, created by Rx-360 member company supply chain security experts, provides industry and other stakeholders with a comprehensive overview of fundamental elements that can be considered for a mature supply chain security program, and provides an introduction to other key program elements that will be expanded on in subsequent white papers and guidelines.    

Brian Johnson, Co-Leader of the Rx-360 Supply Chain Initiative and Pfizer's Senior Director of Supply Chain Security stated “The vision behind establishing Rx360’s new Supply Chain Security Team last year was to get subject matter experts from across the entire supply chain working together on a holistic approach to enhance supply chain integrity.  This first paper on SCS management systems is outstanding and really delivers on that vision.”

Additional Rx-360 White Papers are being developed on several topics and will be released shortly.  The following is a list of upcoming Rx-360 White Papers to be published:

  • Rx-360 Supply Chain Security White Paper: Cargo Theft Risk Assessment
  • Rx-360 Supply Chain Security White Paper: Threats and Monitoring Processes
  • Rx-360 Supply Chain Security Guideline for Audits/Assessments of Third Party Providers

Shortly after the release of each White Paper, Rx-360 will conduct a free webinar explaining how to implement the concepts contained within each Rx-360 White Paper.

About Rx-360:

Rx-360 was formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. The mission of the new organization is timely in light of growing attacks and threats to an increasingly complex and global supply chain. Millions of people around the world are treated every day with the vital medicines that pharmaceutical and biotechnology companies provide. Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that Rx-360 is positioned to help resolve. To learn more about Rx-360 go to the Rx-360 website at www.Rx-360.org.

  

 

 

 

  

S.1886 Counterfeit Drug Penalty Enhancement Act of 2011. Minimize

S.1886 Counterfeit Drug Penalty Enhancement Act of 2011.


Rx-360 Issued: 05-January-2012

Senate 1886 Counterfeit Drug Penalty Act of 2011 represents an attempt to increase the penalties for trafficking in counterfeit drugs.  Numerous reports have suggested that the consequences for manufacture and selling of counterfeit drugs need to be strengthened.  This short draft bill addresses both financial consequences as well as sentencing guidelines. 

To view or download the proposed Bill, click here

To view or download the Rx-360 Summary,
click here 

 

 

  

 

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