This electronic document was downloaded from the GPO web site, July 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.30]
[Page 346-347]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
Subpart A--Foods
Sec. 73.30 Annatto extract.
(a) Identity. (1) The color additive annatto extract is an extract
prepared from annatto seed, Bixa orellana L., using any one or an
appropriate combination of the food-grade extractants listed in
paragraph (a)(1) (i) and (ii) of this section:
(i) Alkaline aqueous solution, alkaline propylene glycol, ethyl
alcohol or alkaline solutions thereof, edible vegetable oils or fats,
mono- and diglycerides from the glycerolysis of edible vegetable oils or
fats. The alkaline alcohol or aqueous extracts may
[[Page 347]]
be treated with food-grade acids to precipitate annatto pigments, which
are separated from the liquid and dried, with or without intermediate
recrystallization, using the solvents listed under paragraph (a)(1)(ii)
of this section. Food-grade alkalis or carbonates may be added to adjust
alkalinity.
(ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl
alcohol, methylene chloride, trichloroethylene.
(2) Color additive mixtures for food use made with annatto extract
may contain only diluents that are suitable and that are listed in this
subpart as safe in color additive mixtures for coloring foods.
(b) Specifications. Annatto extract, including pigments precipitated
therefrom, shall conform to the following specifications:
(1) Arsenic (as As), not more than 3 parts per million; lead as Pb,
not more than 10 parts per million.
(2) When solvents listed under paragraph (a)(1)(ii) of this section
are used, annatto extract shall contain no more solvent residue than is
permitted of the corresponding solvents in spice oleoresins under
applicable food additive regulations in parts 170 through 189 of this
chapter.
(c) Uses and restrictions. Annatto extract may be safely used for
coloring foods generally, in amounts consistent with good manufacturing
practice, except that it may not be used to color foods for which
standards of identity have been promulgated under section 401 of the act
unless added color is authorized by such standards.
(d) Labeling. The label of the color additive and any mixtures
prepared therefrom and intended solely or in part for coloring purposes
shall conform to the requirements of Sec. 70.25 of this chapter. Labels
shall bear information showing that the color is derived from annatto
seed. The requirements of Sec. 70.25(a) of this chapter that all
ingredients shall be listed by name shall not be construed as requiring
the declaration of residues of solvents listed in paragraph (a)(1)(ii)
of this section.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health and
therefore batches thereof are exempt from the certification requirements
of section 721(c) of the act.
Ziagen®
Brand Name: Ziagen®
Active Ingredient: abacavir sulfate
Strength(s): 300mg oral tablets or 20mg/ml oral solution
Dosage Form(s): Tablets and Oral solution
Company Name: GlaxoSmithKline
Availability: Prescription only
*Date Approved by the FDA:
December 17, 1998
*Approval by FDA does not mean that the drug is available for consumers at this time.
What is Ziagen used for?
Ziagen is used to treat HIV-1 infection in combination with other antiretroviral medications. Ziagen is only proven to work when taken in combination with other antiretroviral medications. Ziagen belongs to the class of drugs known as nucleoside reverse transcriptase inhibitors.
Special Warnings Concerning Ziagen:
If you experience signs or symptoms of a hypersensitivity reaction (severe allergic reaction) at any time while you are taking Ziagen, you must stop taking Ziagen and contact your health care provider immediately. If you have a skin rash or two or more of the following symptoms you may be having a hypersensitivity reaction:
- fever
- nausea, vomiting, diarrhea, or stomach pain
- severe tiredness, achiness, or a general ill feeling
- sore throat, cough, or shortness of breath
A medication guide for patients comes with every Ziagen prescription. Read the medication guide carefully. In addition, your pharmacist will give you a warning card listing the symptoms of a Ziagen allergy. Carry this card with you.
Ziagen can cause a condition called lactic acidosis (accumulation of lactic acid in the body) together with an enlarged liver, which can be a serious and sometimes fatal.
If you have a history of liver problems, your health care provider will evaluate and decide if Ziagen is right for you.
General Precautions with Ziagen:
- Because resistance to the HIV virus can occur quickly with single-drug treatment, Ziagen should always be taken in combination with other antiretroviral medications. Ziagen should not be taken alone to treat HIV. If your current treatment is failing, Ziagen should not be added as a single agent.
- Ziagen is not a cure for HIV infection. At present, there are no results from studies evaluating long term suppression of HIV or disease progression. You may continue to experience illnesses associated with HIV infection, including opportunistic infections.
- You should remain under the care of a physician when using Ziagen. If you stopped taking Ziagen for reasons other than a severe allergic reaction, it is possible to begin taking Ziagen again with continued monitoring by your doctor for such a reaction.
- Ziagen has not been shown to reduce the risk of transmission to others through sexual contact or blood contamination.
Tell your doctor or health care provider if you are:
- trying to become pregnant or are pregnant.
- breast-feeding or thinking about breast-feeding while taking Ziagen.
Carry the warning card of Ziagen allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking Ziagen. Serious and life threatening allergic reactions have been associated with Ziagen (See "Special Warnings").
Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main body. Loss of fat from the legs, arms, and face may also happen.
Other side effects of Ziagen include:
- fever
- rash
- nausea
- vomiting
- feeling tired
- diarrhea
- loss of appetite
- trouble sleeping
- joint pain
- swelling
- shortness of breath
Tags: hiv, infection, inhibitors, ziagon
Product Name: Epicel® cultured epidermal autograft (CEA)
How does it work? Epicel® replaces the patient’s top skin layer, or epidermis. The skin serves to protect the patient from infection and fluid loss.
What will it accomplish? In deep dermal or full thickness burns, the outer epidermal layer of the skin and most or all of the dermis (inner layer of the skin) is destroyed. Due to the depth of the injury, regeneration of the skin is greatly reduced. In patients that are severely burned, the patient does not have enough donor skin available to cover the wounds. The physician may need to consider other means of permanent wound closure treatment, such as Epicel®, to treat the patient’s wounds. The Epicel® graft replaces the epidermal or top layer of the skin. This layer of skin is required to close or heal the wound.
Brand Name: Antagon Injection®
Active Ingredient: ganirelix acetate
Strength(s): 250 mcg/0.5 ml
Dosage Form(s): Injection
Company Name: Organon, Inc.
Availability: Prescription only
*Date Approved by the FDA: July 29, 1999
*Approval by FDA does not mean that the drug is available for consumers at this time.
What is Antagon? Antagon is used to inhibit premature ovulation in women undergoing fertility procedures.
Who should not use Antagon?
Women who have experienced a hypersensitivity reaction to gonadotropin-releasing hormone (GnRH) or any other GnRH-type drug.
Women who suspect or know they are pregnant.
Special Warnings with Antagon:
A physician specializing in fertility treatment should prescribe Antagon.
Before starting treatment with Antagon, pregnancy must be ruled out.
General Precautions with Antagon:
Patients with hypersensitivity to GnRH should be closely monitored after the first injection.
The packaging of Antagon contains natural rubber latex that may cause allergic reactions.
You will need to be examined on a regular basis when using Antagon.
What should I tell my doctor or health care provider?
Tell your doctor if you are pregnant or breast-feeding. Women who are pregnant or breast-feeding should not use Antagon.
What are some possible side effects of Antagon? (This is NOT a complete list of side effects reported with Antagon. Your health care provider can discuss with you a more complete list of side effects.)
The most frequent side effects of Antagon are:
Abdominal pain
Fetal death
Headache
For more detailed information about Antagon, ask your health care provider.
Posted: 5/2/00Updated: 10/31/00, 12/29/04ghc
Tags: antagon, fertility, injections, ovilation