What science is the BUD section based on? The "Briefing" states this new revision is based on "new science" but there is no documentation, references, etc. which should be available for confirmation by practitioners.

The chapter goes into extensive detail about how:

1. to ensure sterility
2. to explain the different parameters to be considered
3. to explain that both sterility and stability considerations must be taken into account when establishing a BUD
4. to present stability considerations (1397-1419)

BUT then states that:

• BUDs for CSPs must be established in accordance with Table 7 for Category 1 CSPs and Table 8 for Category 2 CSPs. (Lines 1421-2)
• BUDs in Table 7 and Table 8 for CSPs are based on the risk of microbial contamination, not the physical or chemical stability of the CSP. (Lines 1425-1431)
• if there is any indication that the particular preparation will not remain chemically or physically stable for the specified period, a shorter BUD must be assigned. (Lines 1432-1436)
• the shorter BUDs in Table 8 for aseptically prepared CSPs that are not sterility tested must not be exceeded. (Lines 1444-1445)

HOWEVER, what is to be done if they ARE sterility tested and are stable? I don't see any provision for going beyond the BUDs in Table 8.

The chapter states that one must "look at ALL issues to assign a BUD; BUT, the chapter shows and states the BUDs only consider "sterility" (with the exception of those CSPs that are not stable).

My Comments:
It does not look like there are any alternatives or flexibility (pharmaceutical judgment). Is this what is really intended? This chapter has a tremendous impact on CSP availability throughout the US (and the world) and needs to be reasonable and effective for patient care.

If a USP <71> sterility assurance level (SAL) of 1 x 10^-6 is achieved, a sterile preparation should remain sterile. Where is the science that says it goes from sterile to nonsterile if properly sealed and stored?

• A CSP cannot be sterile on day 28 and suddenly nonsterile on day 29.
• A CSP cannot be sterile on day 42 and suddenly nonsterile on day 43.

Why not a simple statement that if the CSP is improperly stored or the seal becomes challenged, then it should be immediately discarded?

If studies show that a CSP is physically/chemically stable for up to 60 days, 90 days, or even 6 months and it is sterility tested according to USP <71>, is that data of no value? If not, there are hundreds of published studies that may be of little or no value when the chapter becomes official. Does USP <71> adherence mean different things for manufacturers vs compounders? It looks like discrimination in the application of official USP standards.

In summary and sad to say, I don't see any real science behind Tables 7 and 8, just opinions.

As we have stated so often in this Newsletter, "Question Everything" and "Show me the science!"

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

14 Indicted at NECC: Includes Murder Charges
An indictment against 14 New England Compounding Center (NECC) owners and employees not only accuses them of selling nonsterile drugs that infected hundreds of patients, but also includes 25 murder charges against two lead pharmacists.The 131-count criminal indictment charges owner and head pharmacist Barry J. Cadden and NECC supervisory pharmacist Glenn A. Chin with 25 acts of second-degree murder for deaths of patients in 7 states. If convicted, they face up to life in prison. Last September, Chin was intercepted by federal agents when he was about to board a plane for Hong Kong.
http://www.fiercepharma.com/story/indictment-14-necc-includes-murder-charges/2014-12-18

Patients Struggle as Insurers Limit Coverage for Compounded Medications
From a fungal meningitis outbreak blamed on unsafe conditions at a Massachusetts compounding pharmacy that killed dozens of people to a few compounding pharmacies producing pain creams costing thousands of dollars with minimal therapeutic benefits, compounding pharmacists say patients with legitimate medical needs have had a harder time getting insurance coverage for compounded drugs. This means they must pay out of pocket or find a different medication. Although several Massachusetts insurers said they still cover medically necessary drugs, many have put new restrictions on coverage.
http://www.masslive.com/politics/index.ssf/2015/10/patients_struggle
_as_insurers.html

Medicare Rates Set to Soar
The year 2016 will see an unprecedented premium increase for millions of recipients in 2016. About 30% of the roughly 52 million people enrolled in Medicare Part B could see a 52% rise in those premiums if Congress and the Obama administration don't find a way to freeze or reduce the increase. New beneficiaries, those with high incomes and Medicare recipients who don't get Social Security would be hit with the increase of about $55 a month, or about $650 a year.
http://www.wsj.com/articles/medicare-rates-set-to-soar-1444865843?cb=logged0.2742262115210053

Indian Drug Retailers Protest Against e-Pharmacies
Indian drug retailers closed for the day on Wednesday to protest against the country's growing online pharmacy industry, and threatened to close indefinitely if the federal government did not shut down e-pharmacies. The nationwide protest was widely supported with as many as 850,000 chemists closing their doors; this left patients waiting in long queues at any pharmacies that were open. Drug retailers are worried. "It is a matter of our livelihoods, we must be prepared for a fight," said pharmacist Satish Vij.
http://www.reuters.com/article/2015/10/14/us-india-pharmacies-strike-idUSKCN0S81ON20151014

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Did You Know ...

... When the FDA comes to inspect your compounding pharmacy, they are looking for�

• any evidence of either domperidone or ephedra compounding?
• full compliance with the 2003 "do not compound" list?
• any instance of compounding and dispensing for anyone other than an individually identifiable patient?
• SOPs showing how drugs are tested for sterility and potency?
• a list of ALL your compounded preparations for the past 90 days?

(Provided by David Miller, R.Ph., IACP CEO)

Tip of the Week

Now is the time to "Get Informed" and to "Get Involved"! If you don't, your patients are going to suffer in the future due to lack of availability of required compounded medications! More harm is often done by over-regulation than by proper enforcement of current laws and proper education.

Looking Back

He tried to cross,
As fast train neared.
Death didn't draft him,
He volunteered!
     Burma Shave