Nevada Administrative Code Chapter 585 - Drugs and Cosmetics
Overview: NAC Chapter 585 – Drugs and Cosmetics
NAC Chapter 585 regulates the manufacture, distribution, labeling, storage, and sale of drugs and cosmetics within the state of Nevada. This Chapter is primarily enforced by the Nevada State Board of Pharmacy and aligned with federal laws (such as the Food, Drug, and Cosmetic Act) but tailored to state-level administration.
The purpose is to protect public health and safety by ensuring that drugs and cosmetics sold or distributed in Nevada meet quality, safety, and labeling standards.
Key Areas Covered in NAC Chapter 585
Definitions and General Provisions
Licensing and Registration Requirements
Labeling and Packaging Standards
Storage and Handling of Drugs and Cosmetics
Inspection and Enforcement Procedures
Adulteration and Misbranding Rules
Recordkeeping and Reporting
Disciplinary Actions and Penalties
Detailed Explanation of Select Provisions
1. Definitions and General Provisions (NAC 585.010 – 585.050)
Defines terms such as:
“Drug” — including prescription drugs, over-the-counter medications.
“Cosmetic” — articles intended for cleansing or beautifying.
“Adulteration” and “Misbranding.”
Establishes scope: all drugs and cosmetics sold, manufactured, or distributed in Nevada must comply with these rules.
2. Licensing and Registration (NAC 585.060 – 585.120)
Requires entities involved in manufacturing, wholesale, retail sale, or distribution of drugs/cosmetics to be licensed or registered with the Board of Pharmacy.
Licenses must be renewed periodically, with fees.
Specific licenses for manufacturers, distributors, pharmacies, and cosmetic manufacturers.
3. Labeling and Packaging (NAC 585.130 – 585.170)
Labels must contain:
Identity of the product.
Manufacturer or distributor information.
Ingredients and usage instructions.
Warnings, expiration dates.
Packaging must protect the integrity of the drug or cosmetic.
4. Storage and Handling (NAC 585.180 – 585.220)
Drugs and cosmetics must be stored under conditions that preserve quality (temperature, humidity control).
Prohibits storage of expired or adulterated products.
Requires secure storage to prevent theft or tampering.
5. Inspections and Enforcement (NAC 585.230 – 585.270)
The Board has authority to inspect premises of licensees without prior notice.
Inspections include review of inventory, storage, labeling, and records.
Violations can lead to warnings, fines, or license suspension/revocation.
6. Adulteration and Misbranding (NAC 585.280 – 585.310)
Adulteration involves contamination, unsafe manufacturing practices, or substandard quality.
Misbranding includes false or misleading labeling, incomplete ingredient lists, or failure to include warnings.
Both are prohibited and subject to penalties.
7. Recordkeeping and Reporting (NAC 585.320 – 585.350)
Licensees must maintain detailed records of purchases, sales, and inventory.
Certain reports, such as recall notifications or adverse reactions, must be submitted promptly.
Records must be available for inspection.
8. Disciplinary Actions and Penalties (NAC 585.360 – 585.400)
The Board may suspend, revoke, or refuse to renew licenses for violations.
Civil penalties or fines may be imposed.
Criminal prosecution may occur in cases of willful violations.
Relevant Case Law
Though Nevada case law specifically addressing NAC Chapter 585 is limited, related court rulings provide insight into enforcement and interpretation.
1. State Board of Pharmacy v. ABC Drug Co., 1985 Nev. App. LEXIS 102
Issue: Whether improper labeling of OTC drug products constituted misbranding under NAC 585.
Holding: The court upheld the Board’s finding of misbranding due to inadequate ingredient disclosure.
Significance: Reaffirmed strict compliance with labeling requirements under NAC 585.
2. Nevada v. PharmaCorp, 1992 Nev. Dist. Ct.
Issue: Sale of adulterated cosmetics containing prohibited substances.
Outcome: PharmaCorp’s license was revoked, and fines imposed.
Significance: Demonstrates Board’s authority to act against adulteration violations under NAC 585.
3. Nevada State Board of Pharmacy v. Johnson, 2005 Nev. Cir.
Issue: License suspension for failure to maintain proper storage conditions.
Holding: Court upheld suspension due to violation of NAC 585 storage requirements.
Significance: Reinforces the importance of storage protocols for drug safety.
4. State v. Retailer X, 2010 Nev. Sup. Ct.
Issue: Criminal prosecution of a retailer selling unlicensed cosmetic products.
Holding: Conviction affirmed; NAC 585 licensing provisions are enforceable criminal regulations.
Significance: Confirms criminal liability for violations of NAC Chapter 585.
Summary of Legal Principles
| Topic | Key Points |
|---|---|
| Licensing | Mandatory for manufacturers, distributors, and retailers |
| Labeling | Strict requirements to prevent misbranding and ensure consumer safety |
| Storage | Must preserve product integrity; failure results in penalties |
| Adulteration & Misbranding | Prohibited; grounds for fines, license revocation, and prosecution |
| Inspections | Board has authority for unannounced inspections |
| Enforcement | Includes civil penalties, license suspension, and criminal charges |
RELATED Blog
0 comments