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We will look at the Right to Try Act of 2017 over the next 2 to 3 weeks to aid in understanding what all is involved in this Act and provide some information on how it may affect pharmacists.
H.R. 878
The stated purpose of the Act is:
To authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.
General
In general, the Federal Government shall not take any action to prohibit or restrict:
- the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that
- is intended to treat a patient who has been diagnosed with a terminal illness; and
- is authorized by, and in accordance with, State law; and
- the possession or use of an experimental drug, biological product, or device for which the patient has received a certification from a physician, who is in good standing with the physician's certifying organization or board, that the patient has exhausted, or otherwise does not meet qualifying criteria to receive, any other available treatment options.
Liability
Notwithstanding any other provision of law, no liability shall lie against a
- producer,
- manufacturer,
- distributor,
- prescriber,
- dispenser,
- possessor, or
- user
of an experimental drug, biological product, or device for the
- production,
- manufacture,
- distribution,
- prescribing,
- dispensing,
- possession, or
- use
of an experimental drug, biological product, or device that is in compliance with this law.
To be continued next week.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Tip of the Week
Along with Belladonna and Opium Suppositories, over 108 items, mostly injectables, are in short supply, including the following non-injectables:
- Disopyramide Phosphate Capsules
- Dorzolamide Ophthalmic Solution
- Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
- Eflornithine HCl Cream
- Gemifloxacin Mesylate Tablets
- Guanfacine HCl Tablets
- Isocarboxazid Tablets
- Liotrix Tablets
- Mupirocin Calcium Nasal Ointment
- Sacrosidase Oral Solution
- Thioridazine HCl Tablets
- Zolpidem Tartrate Sublingual Tablets
The complete list is available at:
https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
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