Aluminum in IV solutions was then shown to impair neurological development, with infants who received 45 micrograms/Kg/day compared to 5 micrograms/Kg/day having a reduced Bayley Mental Development Index of 1 point per day of exposure!
[ref. Bishop NJ, Morley R, Day JP, Lucas A aluminum neurotoxicity in preterm infants receiving intravenous-feeding solutions. N. Eng. J Med 1997;336:1557-1561.]
The FDA (Food and Drug Administration) has had a ruling in place for the past decade not to exceed 5 micrograms/Kg/day of parenteral aluminum.
Parenteral means IV or IM (injected).
The CDC continues to ignore this data and ruling calling for the injection of 250 micrograms of aluminum to all newborns born in the USA which is more than 10X (1000%) of the maximum allowable dose of aluminum injected with the Hepatitis B vaccine.
The complete FDA document is presented here:
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CFR - Code of Federal Regulations Title 21
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The information on this page is current as of April 1 2015.
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2015]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 201 -- LABELING
Subpart G--Specific Labeling Requirements for Specific Drug Products
Sec. 201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition.
(a) The aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed 25 micrograms per liter ([micro]g/L).
(b) The package insert of LVP's used in TPN therapy must state that the drug product contains no more than 25 [micro]g/L of aluminum. This information must be contained in the "Precautions" section of the labeling of all large volume parenterals used in TPN therapy.
(c) Except as provided in paragraph (d) of this section, the maximum level of aluminum present at expiry must be stated on the immediate container label of all small volume parenteral (SVP) drug products and pharmacy bulk packages (PBPs) used in the preparation of TPN solutions. The aluminum content must be stated as follows: "Contains no more than __ [micro]g/L of aluminum." The immediate container label of all SVP's and PBP's that are lyophilized powders used in the preparation of TPN solutions must contain the following statement: "When reconstituted in accordance with the package insert instructions, the concentration of aluminum will be no more than __ [micro]g/L." This maximum level of aluminum must be stated as the highest of:
(d) If the maximum level of aluminum is 25 [micro]g/L or less, instead of stating the exact amount of aluminum as required in paragraph (c) of this section, the immediate container label may state: "Contains no more than 25 [micro]g/L of aluminum." If the SVP or PBP is a lyophilized powder, the immediate container label may state: "When reconstituted in accordance with the package insert instructions, the concentration of aluminum will be no more than 25 [micro]g/L".
(e) The package insert for all LVP's, all SVP's, and PBP's used in TPN must contain a warning statement. This warning must be contained in the "Warnings" section of the labeling. The warning must state:
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 [micro]g/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
(f) Applicants and manufacturers must use validated assay methods to determine the aluminum content in parenteral drug products. The assay methods must comply with current good manufacturing practice requirements. Applicants must submit to the Food and Drug Administration validation of the method used and release data for several batches. Manufacturers of parenteral drug products not subject to an approved application must make assay methodology available to FDA during inspections. Holders of pending applications must submit an amendment under 314.60 or 314.96 of this chapter.
[65 FR 4110, Jan. 26, 2000, as amended at 67 FR 70691, Nov. 26, 2002; 68 FR 32981, June 3, 2003]
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