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Editorial: Current Good Manufacturing Practice (cGMP) Regulations, Part 7

This week, we will summarize Subpart E: Control of Components and Drug Product Containers and Closures. The following are the subpart sections and a brief description of their content.

211.80 General Requirements
This introduction to the section sets forth the requirement for written detailed procedures for the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures. All these items must be handled and stored to prevent contamination and shall be designated with a code to prevent mix-ups.

211.82 Receipt and Storage of Untested Components, Drug Product Containers and Closures
This section describes the procedures for receipt, examination, and storage of components addressed in this section.

211.84 Testing and Approval or Rejection of Components, Drug Product Containers and Closures
Components must not be used until they are sampled, tested, and examined, as appropriate. There are many more details included in this section.

211.86 Use of Approved Components, Drug Product Containers and Closures
Following acceptance, components shall be rotated and the oldest used first.

211.87 Retesting of Approved Components, Drug Product Containers and Closures
Components shall be retested as indicated and appropriate.

211.89 Rejected Components, Drug Product Containers and Closures
Rejected components shall be quarantined in such a manner to prevent their use.

211.94 Drug Product Containers and Closures
Drug product containers shall not be reactive, additive, or absorptive such that they alter the safety, identity and strength, quality, or purity of the drug beyond its established standards.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy

Pharmacies Push Back on New Regulations
Pharmacies are pushing back on calls for more federal regulations after a "60 Minutes" report on a deadly fungal meningitis outbreak. The National Community Pharmacists Association (NCPA) says there are already "adequate" regulations in place to protect consumers who visit small-batch pharmacies that mix custom prescriptions.

NCPA said the New England Compounding Center (NECC), which manufactured hundreds of injectable pain medications contaminated with fungal meningitis, is a "rogue entity." B. Douglas Hoey, the chief executive of the NCPA, said the company passed itself off as a compounding pharmacy while producing large quantities of drugs.

"As a country, we must strike the right balance to go after rogue entities like NECC while preserving patients' access to the safe and essential compounded medications that their physicians prescribe," Hoey said, pledging that the organization would "continue to work with health officials" on the issue.
http://thehill.com/blogs/regwatch/healthcare/287441-pharmacies-push-back-on-call-for-regulations-after-60-minutes-report

Dollars for Docs and Millionaires
Dr. Jon W. Draud, the medical director of psychiatric and addiction medicine at two Tennessee hospitals, pursues some unusual and expensive passions. He's bred sleek Basenji hunting dogs for show, and, last summer, the Tennessee State Museum featured "African Art: The Collection of Jon Draud." The Nashville psychiatrist is also notable for a professional pursuit: During the last four years, the 47-year-old Draud has earned more than $1 million for delivering promotional talks and consulting for seven drug companies.

By a wide margin, Draud's earnings make him the best-paid speaker in ProPublica's Dollars for Docs database, which has been updated to include more than $2 billion in payments from 15 drugmakers for promotional speaking, research, consulting, travel, meals, and related expenses from 2009 to 2012. Payouts to hundreds of thousands of physicians are now included in the database.

Draud is not the only high earner: 21 other doctors have made more than $500,000 since 2009 giving talks and consulting for drugmakers, the database shows. And half of the top earners are from a single specialty—psychiatry.

Paid speaking is perfectly legal, and, if people want to work for drug companies, this is America whose specialty has often been criticized for its over-reliance on medications. But, just to be clear—this is marketing.

The companies say physician speakers are the best messengers to teach their peers about new and effective treatments. But critics counter that the speakers are little more than highly credentialed pitchmen who typically use the drug companies' slides and talking points to sell rather than educate.
http://www.propublica.org/article/dollars-for-docs-mints-a-millionaire

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�that St. Patrick's Day, although not a legal holiday in the U.S., is widely recognized and celebrated throughout the country? It is primarily observed as a celebration of Irish and Irish American culture; celebrations include prominent displays of the color green, feasting, religious observances, and parades. The holiday has been celebrated on the North American continent since the late eighteenth century.

It is a cultural and religious holiday celebrated on March 17 and is named after Saint Patrick (c. AD 385-461), the most commonly recognized of the patron saints of Ireland. According to legend, St. Patrick used the 3-leaved shamrock to explain the Holy Trinity to the Irish people.

Place some green-colored liquid in your Showglobes to celebrate St. Patrick's Day. Green also has been said to be the professional color of pharmacy.

No use knowing,
How to pick'em,
If your half-shaved,
Whiskers stick 'em!
      Burma Shave

The APhA now has a Compounding Special Interest Group. March 22 is the deadline to get another 30 members in the group to achieve official status. With your "APhA member number" handy, go to the following website to enroll.

http://fs10.formsite.com/APHA-APPM/form78/index.html