(Learning about USP Chapter <800> in 10 minutes a week.)

18. MEDICAL SURVEILLANCE
18.1 Follow-Up Plan

If exposure-related health changes occur, the entity SHOULD take the following actions:

• Perform a post-exposure examination related to the type of exposure.
• Assessment of the extent of exposure.
• Compare performance of controls with recommended standards.
• Conduct environmental sampling when analytical methods are available.
• Verify and document engineering controls are operating properly.
• Verify and document the exposed worker complied with policies.
• Develop and document a plan of action to prevent additional exposure of workers.
• Ensure confidential, two-way communication between worker and employee health unit(s) regarding notification, discussions, or adverse health-effect detection.
• Provide and document a follow-up medical survey to demonstrate the implemented plan is effective.
• Ensure any exposed worker receives confidential notification of any adverse health effect; also, offer alternative duty opportunities.
• Provide ongoing medical surveillance of all workers at risk for exposure to HDs to determine the implemented plans effectiveness.

The following is additional information appended to the end of the chapter:

• Glossary
• Appendix 1: Acronyms
• Appendix 2: Examples of Designs for Hazardous Drug Compounding Areas
• Appendix 3: Types of Biological Safety Cabinets
• References

NOTE: USP responses to these questions will soon be posted on the USP website. We will announce this as soon as it happens. For a complete list of questions asked so far, please go to: http://www.ijpc.com/USP800Questions

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

News

Near Record for India's Drug Approvals
FDA has been approving generic drug applications from India's firms at a record pace, with smaller companies like Aurobindo Pharma and Glenmark Pharmaceuticals leading the group. In the last six months of 2015, the FDA approved a record 83 new generic drug applications; in the first half of this year, the pace of approvals slowed to 72 through June, still among the best six-month periods in data going back to 2005. India's increasing importance in the U.S. supply of generic medicines is estimated that it accounted for 31% of all new drug approvals last year.
http://www.bloomberg.com/news/articles/2016-07-20/indian-drug-approvals-near-record-despite-fda-inspection-blitz

Repackager Cited by FDA
A drug repackager specializing in single-dose repackaging is in trouble with the FDA; the warning letter was issued for both manufacturing issues and for marketing what the FDA said were unapproved and misbranded drugs. The company involved is GenPak Solutions where issues that inspectors reported were problems with cleaning and sanitizing equipment that was used to package steroids, anticonvulsants, statins, and antidepressants. "You have no assurance that your cleaning processes are adequate to prevent unacceptable levels of residual product and cleaner on product contact surfaces for this equipment," the agency told the company. Also, there were issues with stability testing and quality-control (QC) review. The letter also indicates that the company's QC operation failed to review 42 of the 104 batch production records that inspectors looked over during the visit. http://www.fiercepharma.com/manufacturing/fda-cites-drug-repacker-warning-letter

Former J&J Executives Convicted in Off-label Marketing Case
Former CEO and the sales VP of Acclarent, which J&J's devices unit Ethicon bought in 2010, were found guilty of 10 misdemeanor violations of the FDC Act and now face up to a year in prison for each count. Both were acquitted of more serious fraud charges. William Facteau and Patrick Fabian pushed an Acclarent product for uses the FDA had not approved.
http://www.fiercepharma.com/pharma/a-warning-sign-for-pharma-ex-j-j-execs-are-convicted-off-label-marketing-case

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Did You Know ...

�that it seems that many pharmacists feel that once they have graduated from College they are set for life and the profession owes them a living for the next 50 years?

Tip of the Week

The profession of pharmacy is constantly changing. Just ask someone that has been practicing for 10 to 20 years. Consider the following:

It is necessary to:

1. Constantly read professional articles just to keep up.
2. Participate in professional meetings to know what is going on.
3. Be active professionally to keep pharmacy "on the right track."
4. Contribute financially to those that are fighting for the profession.
5. Always do the right thing for the profession and patients.
6. Always keep track of and value the most important things in life!

Looking Back

Substitutes and imitations
Send 'em to
Your wife's
Relations!
     Burma Shave