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

5. Facilities and Engineering Controls (5.1 and 5.2)

• SIGNS designating hazards must be prominently displayed at entrance to the area.
• Access to the area must be restricted to AUTHORIZED PERSONNEL only.
• Hazard areas must be located AWAY from breakrooms and refreshment areas for personnel, patients, and visitors.
• DESIGNATED AREAS must be available for:
  • Receipt and unpacking
  • Storage of HDs
  • Nonsterile and/or Sterile HD compounding
• Consider uninterrupted power sources (UPS) for ventilation systems.

5.1 Receipt

• HDs must be unpacked in a neutral/normal or negative pressure area; they must not be unpacked in a positive pressure area.

Editorial Note: Nothing is stated about the "Receiving Area"; only where they must be "unpacked." One would understand this to mean that the receiving area has no special requirements�only where they are "unpacked." If they are unpacked in the receiving area, then it must be a neutral/normal or negative pressure area.

5.2 Storage

• Store HDs to prevent spillage or breakage if the container falls.
• Do not store HDs on the floor.
• Shelves with front lips are preferred, especially in areas prone to natural disasters.
  
  
• Antineoplastic HDs requiring only counting or repackaging may be stored with non-HDs.
• Antineoplastic HDs requiring manipulation must be stored separately from non-HDs.
• The storage area must be externally ventilated, negative-pressure with at least 12 air changes per hour (ACPH).
  
  
• Non-antineoplastic HDs in final dosage form may be stored with non-HDs.
• Sterile and nonsterile HDs may be stored together BUT HDs for nonsterile compounding should not be stored in areas for sterile compounding.
  
  
• Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH.
• If a refrigerator is in a negative pressure buffer room, an exhaust located adjacent to the refrigerator's compressor and behind the refrigerator should be considered.

Questions:
Regarding the USP <800> requirement to vent the SEC room outside, this may require a building permit since construction on a facility is involved. What recourse is there for the pharmacy if the city/county building permit to install an EXHAUST VENT from a HAZARDOUS compounding room in the pharmacy is denied?

NEXT WEEK:

5.3 Compounding (5.3.1 Nonsterile Compounding; 5.3.2 Sterile Compounding)

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

Announcements

IACP Names John Voliva Executive Vice President
The International Academy of Compounding Pharmacists (IACP) has named John Voliva, RPh, as its new Executive Vice President. Voliva will assume IACP's EVP role on Monday, April 4, 2016. After a national search, John Voliva's extensive experience made him the clear choice for the position," said Gary McCrory, RPh, CCN, IACP President." John brings a distinctive combination of compounding pharmacy ownership, legislative relations at both a federal and state level, and a strong pharmacist background.

Results of the Sixth Annual National Student Pharmacist Compounding Competition
This year's event was held March 19-20, 2016 at the USC COP in Los Angeles and has grown to 20 teams. The results are as follows:

Overall Winners of the National SPCC 2016:

Formulation Rankings:

Game Show Rankings:

Quality Poster Rankings:

News

Express Scripts Sued by Anthem Over Pricing
Anthem is suing Express Scripts for allegedly charging too much for drugs. The lawsuit, filed in district court in New York, seeks to recover damages for alleged excessive pharmacy pricing and the right to terminate Anthem's contract with Express Scripts. Insurers contract with middleman companies like Express Scripts to negotiate rebates and discounts on behalf of the people they insure and pocket some of the savings for themselves. According to Anthem, Express Scripts' current pricing for their contract now exceeds competitive pricing by $13 billion.
https://www.washingtonpost.com/news/wonk/wp/2016/03/21/anthem-sues-express-scripts-over-prescription-drug-pricing/

Novartis Pays $25M to Settle Bribery Probe
Novartis has agreed to pay $25 million to settle a Securities and Exchange Commission (SEC) investigation into bribery allegations in China, the latest example of corruption claims made against Novartis' operations in Asia. According to the SEC, Novartis paid Chinese doctors lavish entertainments—including trips to Chicago and Niagara Falls—and other inducements to boost prescriptions of its drugs in the country.
http://www.statnews.com/pharmalot/2016/03/23/novartis-bribes-china/

Valeant Hikes the Cost of Aid-In-Dying Medication
Valeant Pharmaceuticals has been the focus of a congressional investigation into high drug prices. When California's aid-in-dying law takes effect this June, terminally ill patients who decide to end their lives could be faced with a hefty bill for the lethal medication, now retailing for more than $3,000. Seconal (secobarbital), which was originally developed in the 1930s as a sleep aid, fell out of favor when people died from taking too much or from taking it in combination with alcohol. But when intended as a lethal medication to hasten the death of someone suffering from a terminal disease, Seconal is the drug of choice. In 2009, the price of a lethal dose of 100 capsules of Seconal was less than $200. Over the next six years, it shot up to $1,500 and when Valeant bought Seconal last February, it immediately doubled the price to $3,000.
http://www.npr.org/sections/health-shots/2016/03/23/471595323/drug-company-jacks-up-cost-of-aid-in-dying-medication

Editor's Note to the above: Just a thought�why would some drug companies refuse to produce/sell a drug product for capital punishment of someone committing heinous crimes�but would sell a drug product to help an innocent individual die and also make an outlandish profit on it?

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Did You Know ...

�that drug companies set prices for drugs based on a number of factors, including:

1. the cost of developing (R&D) or acquiring (purchasing) the drug,
2. the availability of generics, and
3. the benefits of the drug compared with costly alternative treatments?

It is interesting that most drug companies try to justify price hikes by pointing to high research costs; but in the majority of cases research is not required, and it is GREED!

Tip of the Week

"Avarice (greed) is like a pig, which seeks its food in the mud without caring where it comes from." (Jean B. M. Vianney)

Looking Back

"No, no!" she said,
To her bristly beau,
"I'd rather eat,
The mistletoe"!
     Burma Shave