Partial Outline of the Guidance

2. Essentially a Copy of a Commercially Available Drug Product
   1. What is Essentially a Copy?
      1. Same Active Pharmaceutical Ingredient (API)
      2. Same, Similar or Easily Substitutable Strength
      3. Same Route of Administration
      4. Same Characteristics as Two or More Commercially Available Drug Products
   2. Statement of Significant Difference
   3. Documentation of Shortage
   4. Regularly or in Inordinate Amounts
   5. Recordkeeping

***

What is Essentially a Copy?

"Essentially a copy" is described in the Guidance as a copy of a commercially available drug product if:

• The compounded drug product has the same API(s) as the commercially available drug product;
• The API(s) have the same, similar, or an easily substitutable dosage strength; and
• The commercially available drug product can be used by the same route of administration as prescribed for the compounded drug.

Key components are:

• Same API
• Same, Similar, or Easily Substitutable Strength
• Same Route of Administration
• Same Characteristics as Two or More Commercially Available Drug Products

Notes:

• API: Even though the compounded preparation may contain the same API(s), a specific inactive ingredient may be problematic for a patient and produce a significant difference in the product for that patient; this is fine to compound.
• STRENGTH: The FDA considers two drugs to have a similar dosage strength if the dosage strength of the compounded drug is within 10% of the dosage strength of the commercially available drug product. This does not include "easily substitutable strengths of commercial products."
• ROUTE OF ADMINISTRATION: This section can be confusing, as it apparently does not consider bioavailability considerations. Please read the Guidance.
• CHARACTERISTICS: If two or more commercially available drug products are combined in strengths that are within 10% of the respective commercially available products, it is considered to be essentially a copy of the commercially available drug product unless a prescriber determination of a significant difference has been documented.

More next week! Please obtain a complete copy of this Guidance at:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM510154.pdf

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

NOTE: Due to the intense interest in the opioid epidemic, etc., here is some information published this week that may be of benefit in understanding the problem(s).

Opioid Manufacturers Paid Millions for Marketing!

Five opioid manufacturers, including OxyContin maker Purdue Pharma LP, have paid more than $10 million to advocacy groups and doctors linked to them, many of whom amplified industry messages supporting the use of the painkillers, a U.S. Senate report said. The groups involved issued guidance promoting opioids for chronic pain and lobbied against laws to curb their use.

Purdue Pharma, which has announced it would stop promoting opioids to doctors, was the biggest donor followed by Insys Therapeutics Inc., which markets Subsys. Also receiving funds was the U.S. Pain Foundation and the Academy of Integrative Pain Management, along with others in donations to the 14 groups examined.
https://www.reuters.com/article/us-usa-opioids-senate/opioid-makers-paid-millions-to-advocacy-groups-u-s-senate-report-idUSKBN1FX027

More

Even though the opioid marketing came under increasing scrutiny through hundreds of lawsuits and multiple investigations, the industry contributed millions of dollars to advocacy groups that backed wide use of the drugs. The following table shows the contributions paid to patient groups by year:

The advocacy groups downplayed opioid addiction risks, promoted opioids to treat chronic pain, lobbied to change laws that sought to curb opioid use, and fought to reduce accountability for individuals who overprescribed or misbranded the meds, according to the report.
https://www.fiercepharma.com/pharma/drugmakers-paid-10m-to-groups-pushed-wide-opioid-use-investigation-finds

Still More

Opioid Epidemic Costs Top $1T Since 2001
The opioid epidemic has cost more than $1 trillion since 2001-an amount that is expected to continue to grow over the next several years. Altarum, a nonprofit health research and consulting institute, analyzed the cost of the opioid crisis in additional healthcare expenses and lost productivity, and it projects that the addiction epidemic will cost an additional $500 billion between 2017 and 2020, if the current mortality rate persists. The greatest costs came from lost productivity, wages, and tax revenue related to overdose deaths, which the group estimates costs about $800,000 per person.
https://www.fiercehealthcare.com/finance/opioid-epidemic-costs-overdose-altarum-claire-mccaskill-pharmaceutical-companies

And Still More

Purdue Pharma Finally Stops Marketing Opioids to Physicians-and Cuts 200-Plus Representatives in the Process
Purdue Pharma has announced that it will stop promoting its opioid drugs to physicians. Along with the move, it will lay off 200 salespeople, or more than half its staff. The company will now answer doctors' questions about the pain drugs through its medical affairs team.
https://www.fiercepharma.com/marketing/purdue-pharma-finally-stops-marketing-opioids-to-physicians-slashes-sales-team

Meth, the Forgotten Killer, is Back and it's Everywhere
Twelve years after Congress took aggressive action to slow meth use, it has returned with a vengeance. U.S. border agents are seizing 10 to 20 times the amounts they did a decade ago. Experts say street meth has never been purer, cheaper, or more lethal.

When a doctor's prescription was required to purchase pseudoephedrine, it was like someone turned off a switch and sales plummeted. However, the void has been filled by in the Mexican drug cartels, which have inundated the market with a lot of pure, low-cost meth that dealers have more of it than they know what to do with.
https://www.nytimes.com/2018/02/13/us/meth-crystal-drug.html

Did You Know ...

�that it seems that in trying to combat drug abuse over the years, the approaches tend to involve spending more of our tax money on education and treatment with little or no accountability or results?

Tip of the Week

Why not look at the root cause of the problem instead and involve approaches such as enhancing the family; parental responsibility; two-parent families; faith-based initiatives; exposing young people and young adults to more healthy lifestyles, positive groups and activities; etc. Also, removing the glamorization of drug use from television programming, music, etc. may help.

Also, for those involved in drug abuse, why not consider severe and rapid punishment for drug dealers (whoever and wherever they are), treatment and punishment for users, rapid and severe punishment for those involved in fatal accidents (car crashes, etc.) while under the influence of drugs, etc., and others. The namby-pamby approach we have seen in recent years, along with slaps-on-the-wrist, do not appear to work effectively.

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Looking Back

If substitution he should try,
Just look that clerk,
Right in the eye,
And bellow�
     Burma Shave