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Editorial: Current Good Manufacturing Practice (cGMP) Regulations, Part 1

With recent events and discussions of GMPs and compounding, we will begin a new series to discuss the purpose of GMPs, their purpose in drug manufacturing, and do some comparisons with GCPs (Good Compounding Practices) used by compounding pharmacists in all pharmacy practice sites.

Current Good Manufacturing Practice (cGMP or GMP) regulations are established by the FDA to ensure that minimum standards are met for drug product quality in the U.S. A "drug product" is defined as a finished dosage form, for example, tablet, capsules, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.

The first GMP regulations were promulgated in 1963 under the provisions of the Kefauver-Harris Drug Amendments, and, since then, they have been periodically revised and updated.

The cGMP regulations establish requirements for all aspects of pharmaceutical manufacturing. They apply to domestic and to foreign suppliers and manufacturers whose bulk components and finished pharmaceutical products are imported, distributed, or sold in this country. To ensure compliance, the FDA inspects the facilities and production records of all firms covered by these regulations.

The Code of Federal Regulations contains requirements for the "Current Good Manufacturing Practice for Finished Pharmaceuticals" and additional cGMP requirements for biologic products, medicated articles, and medical devices.

An abbreviated topical outline of the cGMP regulations for finished pharmaceuticals is presented below. We will look at these in more detail in the following weeks.

• Subpart A—General Provisions
• Subpart B—Organization and Personnel
• Subpart C—Buildings and Facilities
• Subpart D—-Equipment
• Subpart E—Control of Components and Drug Product Containers and Closures
• Subpart F—Production and Process Controls
• Subpart G—Packaging and Labeling Control
• Subpart H—Holding and Distribution
• Subpart I—Laboratory Controls
• Subpart J—Records and Reports
• Subpart K—Returned and Salvaged Drug Products

Throughout this series, we will do some comparisons between some sections of GMPs and GCPs to enable a better understanding of the roles that GMPs and GCPs play in providing drug products and drug preparations.


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

Tylenol Not Being Stocked in Some Stores to End Empty Shelves
In the wake of manufacturing problems by Tylenol's maker (Johnson & Johnson), problems of which have disrupted supplies for more than three years, CVS has changed how it stocks the drug at its stores. CVS will try to have Tylenol in stores in each market, but will not have it in every store. CVS is receiving sufficient Tylenol to stock about half of its 7,400 U.S. stores, and it changed the stocking of Tylenol to eliminate empty spots on shelves where the medication would have been. This action could be a sign of the difficulty J&J faces as it tries to fix quality-control problems and rebuild its Tylenol manufacturing business. Troubled manufacturing procedures has caused J&J's McNeil unit to recall millions of bottles and packages of Tylenol, Benadryl, Motrin, and other over-the-counter medicines since 2009.

In 2009, Tylenol had 56% market share in the U.S. but, in 2012, the market share was down to 24%. Simultaneously, private-label market share has grown from 32% to 62%.
http://www.reuters.com/article/2013/01/14/cvs-tylenol-idUSL2N0AJENP20130114

For a timeline on the history of the Tylenol recalls, visit:

http://www.fiercepharmamanufacturing.com/story/battered-brand-tylenol-recall-timeline/2011-01-18

E-visits Less Expensive and Just as Good as Office Appointments?
A new study has suggested that "e-visits" for sinus infections and urinary tract infections may be less expensive than in-person office visits and similarly effective. For e-visits, patients fill out online forms about their symptoms, then a doctor or nurse contacts them within a few hours with treatment advice.
http://www.reuters.com/article/2013/01/15/us-evisits-appointments-idUSBRE90E0ZM20130115

Hospitals Fire Employees Refusing Flu Shots
Hospitals' stringent measures coincide with an earlier-than-usual and very serious flu season, where at least 20 children have died. Most doctors and nurses get flu shots, however, in the past two months, at least 15 nurses and other hospital staffers in four states have been fired for refusing, and several others have resigned, according to affected workers, hospital authorities, and published reports.
http://www.journalnow.com/news/local/article_88c69c40-5f90-11e2-84a8-001a4bcf6878.html

Medication Errors Rarely Told to Patients
Patients and their families are rarely told when mistakes are made with their medicines in hospitals, according to a new study.

Most medication mistakes are not harmful to patients, but those that are harmful were more likely to happen in intensive care units (ICUs); ICU patients and families were less likely to be told about errors than patients in other hospital units. About 4% of the errors in ICUs resulted in harm to patients, compared with about 2% of errors in non-ICU wards. Concerning errors that may have led to deaths, 18 occurred in ICUs and 92 in non-ICU areas of the hospital. In both ICUs and non-ICUs, failing to give a patient the medication was the most common error. Harmful errors most often involved devices like IV lines and mistakes in calculating medication dosages. Over half the time, no actions were taken after an error. Also, only a third of the hospital staff making the mistakes was immediately told about their errors. http://www.reuters.com/article/2013/01/11/us-patients-medication-errors-idUSBRE90A16020130111

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�that many state boards of pharmacy are evaluating their laws and regulations regarding compounding?

If you practice in a state that is evaluating and revising their laws and regulations, it is important to get involved and minimize "knee-jerk reactions" resulting in poorly crafted changes and to encourage well thought-out changes to enhance patient safety and quality compounding.

Passing schoolhouses,
Take it slow.
Let the little
Shavers grow!
      Burma Shave