Regulatory Updates

Distribution date: 15 December 2005

The Food and Drug Administration (FDA) is issuing a proposed rule to amend the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA is issuing this proposed rule after considering information submitted in a citizen petition. This proposal is part of FDA's ongoing review of OTC drug products.

Products Covered: Human Drug Products  (HS:  Chapter 3003;  ICS:  11)

Regulation Type: Regular notification

Distribution date: 15 December 2005

The Food and Drug Administration (FDA) is issuing a proposed rule to amend the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA is issuing this proposed rule after considering information submitted in a citizen petition. This proposal is part of FDA's ongoing review of OTC drug products.

Products Covered: Human Drug Products  (HS:  Chapter 3003;  ICS:  11)

Regulation Type: Regular notification

Distribution date: 08 December 2005

EPA is proposing to remove the molecular weight limitations from the tolerance exemption expression for certain polymeric substances codified in 40 CFR 180.960. These exemptions from the requirement of a tolerance were established based on the polymer's meeting the criteria established by the Agency in 40 CFR 723.250, which define a low risk polymer. The Agency is acting on its own initiative.

Products Covered: Pesticide (HS Chapter 3808;  ICS:  65)

Regulation Type: Regular notification

Distribution date: 08 December 2005

EPA is proposing to remove the molecular weight limitations from the tolerance exemption expression for certain polymeric substances codified in 40 CFR 180.960. These exemptions from the requirement of a tolerance were established based on the polymer's meeting the criteria established by the Agency in 40 CFR 723.250, which define a low risk polymer. The Agency is acting on its own initiative.

Products Covered: Pesticide (HS Chapter 3808;  ICS:  65)

Regulation Type: Regular notification

Distribution date: 08 December 2005

Products Covered: Marine paints (HS:  3208, 3209;  ICS:  87.040)

Regulation Type: Regular notification

Distribution date: 08 December 2005

Products Covered: Marine paints (HS:  3208, 3209;  ICS:  87.040)

Regulation Type: Regular notification

Distribution date: 08 December 2005

Products Covered: Zinc Phosphate weldable primer (HS:  3208, 3209; ICS:  87.040)

Regulation Type: Regular notification

Distribution date: 08 December 2005

Products Covered: Zinc Phosphate weldable primer (HS:  3208, 3209; ICS:  87.040)

Regulation Type: Regular notification

Distribution date: 07 December 2005

Products Covered: Marine Paints (HS:  3208, 3209;  ICS:  87.040)

Regulation Type: Regular notification

Distribution date: 07 December 2005

Products Covered: Marine Paints (HS:  3208, 3209;  ICS:  87.040)

Regulation Type: Regular notification