Showing posts with label Bulk. Show all posts
Showing posts with label Bulk. Show all posts

Sunday, October 7, 2012

A Question in the New England Compounding Center Meningitis Case No One Seems to Be Asking: Where Did They Get Their API or Bulk Powders From?

One question that investigators may or may not be looking at, and one that news reports have not seemed to pick up on is where did New England Compounding Center buy its active pharmaceutical ingredients (api) or bulk powders or chemicals from.   Previously reported here on August 29, 2012, was this:


Alarming Report About API from China

Melanie Lee and Ben Hirschler at Reuters have written a Special Report: China's "wild east" drug store dated August 28, 2012.  This report contains alarming information about API from China.  It should be read by everyone and serves as a reminder to ask questions about the source of API used by compounders. To read the report click here.

On June 13, 2012, this was reported on the blog:

The Problems With Buying API From Foreign Sources

The Problems With Buying API From Foreign Sources

More than 80 percent of API is imported into the United States. The problem with buying API from foreign sources is that you do not know what you are getting.  For example, a pharmacetuical representative in Arizona may actually obtain its API from countries such as those in Asia or South America.  In some of these places, quality standards are very lax and counterfeit medications are more widespread and common. The identity, purity, potency and safety of drugs purchased from foreign sources is not guaranteed. It is essential that pharmacists know where the API orginated from even if they are purchasing the API from a company in the United States. Using sources of API whether the API comes from a foreign country or the United States without knowing the identity, purity, potency and safety of drugs simply to save money is not worth the exposure in liability, both civil and criminal, if a patient--human or animal--is injuried or dies from the use of these type of API.  All drugs and API distributed in the United States must comply with the Federal Food Drug and Cosmetic Act, regardless of where they are made. Note that it is illegal (with very few exceptions) to ship prescription drugs that are not approved by FDA into the US, regardless of whether the drug is legal to sell in another country. 


For more information click here.  
To see notes from an FDA seminar on imported API click here.
To review a FDA slide presentation on imported API click here.
To read prior testimony about API, click here.
To read news articles click here,  here,  here and  here
To read a 2012 report on India, click here.
To read an article published April 2012, that suggest better safeguards for imported drugs are needed, click here.
To read the FDA's report entitled Pathway to Global Product Safety and Quality, click here

Hopefully the right people are asking the right questions in the New England Compounding Center Meningitis Outbreak case
.

Tuesday, July 31, 2012

Eu's Newly-Changed Rules On Cgmp Certificate For Bulk Drug Exports



Date :31-Jul-2012
Subject :EU's newly-changed rules on cGMP certificate for bulk drug exports
With the European Union (EU) changing the rules for importing active substances into EU for medicinal products for human use, India may convey the apprehensions of the Indian active pharmaceutical ingredients (API) exporters about the rising cost of transaction costs and seek exemption.

The Commerce Ministry is learnt to have taken note of the changed rules by the EU to be made effective from January 2013 on making mandatory the current good manufacturing practices (cGMP) certificate from the local regulatory authority for all bulk drug exports.

The industry had also apprised the Drug Controller General of India (DCGI) about the hardships including the increase in transaction costs due to the amended laws. Industry leaders, terming the new laws as another non-tariff trade barrier, had urged the Commerce Ministry and the DCGI to take up the matter with the European Union.

Sources said India may convey these apprehensions to the EU in a formal way and seek exemption as sought by some countries like Israel and Switzerland. “The matter is under consideration of the authorities,”a senior official from the Commerce Department said.

To read the remainder of the article click here.

Tuesday, April 17, 2012

FDA Division of Compliance: Inspecting Businesses that May be Manufacturing Under Guise of Compounding

The Division of Compliance of the United States Food and Drug Administration (FDA) has issued assignments to conduct inspections of firms, including internet pharmacies, who may be engaged in the practice of manufacturing under the guise of pharmacy compounding.  The FDA web site contains the following statement regarding Veterinary Drug Compounding.

Inspections, Compliance, and Criminal Investigations

.9.2 - VETERINARY DRUG ACTIVITIES

CVM is responsible for inspections of therapeutic and production drugs, and Active Pharmaceutical Ingredients (APIs). Therapeutic drugs are used in the diagnosis, cure, mitigation, treatment or prevention of disease. Production drugs are used for economic enhancement of animal productivity. Examples include: growth promotion, feed efficiency and increased milk production.
Preapproval inspections are conducted pursuant to pending NADA or ANADA applications.
Post approval inspections of veterinary drugs are conducted to determine compliance with the Current Good Manufacturing Practices (CGMPs) for Finished Pharmaceuticals under 21 CFR Part 2113. These cGMPs apply to both human and veterinary drugs. Information on veterinary drugs approved can be found in the "Green Book" database accessed through CVM's website.
APIs are active pharmaceutical ingredients. Many of the APIs used to manufacture dosage form drugs are imported from foreign countries. The intended source for an API must be indicated in NADA/ANADA submissions for new animal drug approvals. Any change in a source for an API would require a supplement to the application.
Extra label drug use refers to the regulations in 21 CFR Part 5304 codified as a result of the Animal Medicinal Drug Use Clarification Act5 (AMDUCA) of 1994. These regulations set forth the requirements that veterinarians must meet to prescribe extra label uses of FDA approved animal and human drugs. The regulations describe what is a valid veterinary-client-patient relationship as well as what is considered illegal extra label use. 21 CFR Part 530 addresses issues regarding extra label use in non-food as well as food producing animals. 21 CFR 530.416 contains a list of drugs that cannot be used in an extra label manner in food-producing animals. During an inspection or investigation if you encounter any situations on suspected illegal extra label use of any FDA approved animal or human drugs or those prohibited for extra label use in food animals, you should contact CVM's Division of Compliance (HFV-230) (240-276-9200).
21 CFR Part 530 also addresses compounding of products from approved animal or human drugs by a pharmacist or veterinarian. The regulations clearly state compounding is not permitted from bulk drugs. This would include APIs. CVM has an existing CPG on Compounding of Drugs for Use in Animals (CPG 608.4007). A copy can be found on CVM's website. The Division of Compliance (HFV-230) has issued assignments to conduct inspections of firms, including internet pharmacies, who may be engaged in the practice of manufacturing under the guise of pharmacy compounding. You should contact the Division of Compliance (HFV-230) at 240-276-9200 to report instances of compounding or to seek guidance on inspectional issues, or regulatory and enforcement policies.